HUMIRA 40 mg /0.8 Мл Инъекционный Раствор

Наталья Бессолицына

Наталья Бессолицына — врач-ревматолог высшей категории. Проводит онлайн-консультации по диагностике, лечению и сопровождению пациентов с заболеваниями суставов и системными болезнями соединительной ткани. В работе опирается на международные клинические рекомендации и методы доказательной медицины.

С какими симптомами и диагнозами можно обратиться:

Боли в суставах — острая, хроническая, рецидивирующая боль.
Артриты: ревматоидный артрит, псориатический артрит, полиартрит, подагрический артрит.
Артрозы: остеоартроз, коксартроз, гонартроз, узелковый полиостеоартроз.
Плечелопаточный периартрит и спондилоартриты.
Хронические воспалительные заболевания позвоночника — болезнь Бехтерева.
Системные аутоиммунные заболевания: системная красная волчанка, склеродермия, системные васкулиты.
Остеопороз и нарушение плотности костей.

Наталья Бессолицына помогает разобраться в причинах болей, назначает необходимые обследования и подбирает индивидуальное лечение с учётом состояния пациента, образа жизни и риска прогрессирования болезни. Основной акцент — на раннюю диагностику, профилактику осложнений и улучшение качества жизни.

Онлайн-формат позволяет получить квалифицированную ревматологическую помощь независимо от региона проживания.

Записаться на онлайн-консультацию

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Инструкция по применению UMIRA

Содержание инструкции

Humira 20 mg solution for injection in pre-filled syringe
Humira 40 mg/0.8 ml injectable solution
Humira 40 mg injectable solution in pre-filled syringe
Humira 40 mg solution for injection in pre-filled pen
Humira 40 mg injectable solution in pre-filled syringe
1. What is Humira and what is it used for
Humira may slow down the progression of joint damage caused by the disease
Humira 40 mg solution for injection in pre-filled pen
Humira 80 mg injectable solution in pre-filled syringe
Humira 80 mg solution for injection in pre-filled pen

Humira 20 mg solution for injection in pre-filled syringe

adalimumab

Read this leaflet carefully before the child starts using this medicine as it
contains important information.

Keep this leaflet. You may need to read it again.
Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before the child starts taking Humira and during treatment with Humira. You or the child keep this Patient Reminder Card.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed only for the child. Do not give it to other people, even if their symptoms are the same as those of the child, because it could be dangerous.
If the child experiences any side effects, including those not listed in this leaflet, contact the pediatrician or pharmacist. See section 4.

Contents of this leaflet

1. What Humira is and what it is used for
2. What you need to know before the child uses Humira
3. How to use Humira
4. Possible side effects
5. How to store Humira
6. Contents of the pack and other information
7. Humira injection

1. What is Humira and what is it used for

Humira contains the active ingredient adalimumab.
Humira is indicated for the treatment of the inflammatory diseases listed below:

Juvenile idiopathic polyarticular arthritis
Arthritis associated with enthesitis
Pediatric plaque psoriasis
Crohn's disease in pediatric patients
Pediatric uveitis

2. What you need to know before your child uses Humira

Do not use Humira

If your child is allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
If your child has active tuberculosis or other serious infections (see “Warnings and precautions”). It is important to tell your doctor if your child has symptoms of infection, such as fever, wounds, feeling tired, dental problems.
If your child has moderate or severe heart failure. It is important to tell your doctor if your child has had or has a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Humira.
Allergic reactions

If your child experiences allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not give Humira again and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

Infections

If your child has an infection, including long-term infections or infections in a part of the body (for example, leg ulcers), consult your doctor before starting treatment with Humira. If you have any doubts, contact your doctor.
Your child may be more likely to get infections during treatment with Humira. This risk may increase if your child has problems with their lungs. These infections can be serious and include:
tuberculosis
infections caused by viruses, fungi, parasites or bacteria
serious infections in the blood (sepsis)

In rare cases, these infections can be life-threatening to the patient. It is important
to tell your doctor if your child has symptoms such as fever, wounds, feeling tired
or dental problems. Your doctor may tell you to stop Humira for a period of time.

Tell your doctor if your child lives in or travels to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
Tell your doctor if your child has had recurrent infections or if they have conditions that increase the risk of infection.
Your child and their pediatrician should pay particular attention to signs of infection while your child is being treated with Humira. It is important to tell your pediatrician if symptoms of infection such as fever, wounds, feeling tired or dental problems appear.

Tuberculosis

Because cases of tuberculosis have occurred in patients treated with Humira, your doctor will need to check if your child has signs or symptoms typical of tuberculosis before starting therapy with Humira. This will involve a thorough medical assessment of your child’s medical history and appropriate clinical tests (for example, a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded in your child’s Patient Reminder Card.
It is very important to tell your doctor if your child has ever had tuberculosis, or if your child has been in contact with someone who has had tuberculosis. If your child has active tuberculosis, they should not take Humira.
Tuberculosis can develop during therapy even if your child has received treatment to prevent tuberculosis.
Contact your doctor immediately if symptoms of tuberculosis (such as a cough that does not go away, weight loss, lack of energy, mild fever) or other infections appear during or after therapy.

Hepatitis B

It is very important to tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if they have an active infection with the hepatitis B virus or if you think they may be at risk of contracting the hepatitis B virus.
Your doctor should test your child for hepatitis B virus infection. In subjects who test positive for HBV, Humira may cause the virus to become active again.
In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of the hepatitis B virus can be life-threatening to the patient.

Surgery or dental procedures

If your child is to undergo surgery or dental procedures, tell your doctor that your child is taking Humira. Your doctor may recommend temporarily stopping Humira.

Demyelinating diseases

If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide whether it is appropriate for them to start or continue treatment with Humira. Tell your doctor immediately if your child experiences symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccinations

Certain vaccines can cause infections and should not be given during treatment with Humira.
Consult your doctor before vaccinating your child.
It is recommended, if possible, to give children all vaccinations recommended for their age before starting treatment with Humira.
If the mother has taken Humira during pregnancy, the child may have a higher risk of contracting this infection.
It is important to tell the pediatrician and other healthcare professionals about the use of Humira during pregnancy, before the child receives any vaccinations. For more information on vaccinations, see “Warnings and precautions”.

Heart failure

If your child has mild heart failure and is treated with Humira, their heart failure status must be carefully monitored by the doctor. It is important to tell your doctor about any heart problems, past or present. If they develop new symptoms of heart failure or if existing symptoms worsen (e.g. shortness of breath or swelling of the feet), contact your doctor immediately. The doctor will decide if your child can take Humira.

Fever, bruising, bleeding or paleness,

In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. Your doctor may decide to stop therapy. If your child has a persistent fever, develops easy bruising or bleeding, or paleness, see your doctor immediately.

Cancer

Very rarely, some types of cancer have occurred in patients, both children and adults, treated with Humira or other anti-TNF drugs.
Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow).
If your child takes Humira, the risk of developing lymphoma, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with Humira. Some of these patients were also taking azathioprine or 6-mercaptopurine.
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
Cases of non-melanoma skin cancer have been observed in patients taking Humira.
If new skin lesions appear during or after therapy, or if the appearance of existing lesions changes, tell your doctor.
Cases of neoplasms, in addition to lymphoma, have occurred in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another anti-TNF. If your child suffers from COPD, or smokes heavily, they should discuss with their doctor whether treatment with an anti-TNF is appropriate.

Autoimmune disease

Rarely, treatment with Humira can lead to the development of a syndrome like lupus. Tell your doctor if you experience symptoms such as a persistent unexplained rash, fever, joint pain or fatigue.

Other medicines and Humira
Tell your doctor or pharmacist if your child is taking, has recently taken or might
take any other medicines.
Your child should not use Humira with medicines that contain the following active ingredients due to the
increased risk of having serious infections:

anakinra
abatacept.

Humira can be used with:

methotrexate
other disease-modifying antirheumatic drugs (e.g. sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts)
steroids or pain relievers, including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have any doubts, ask your doctor.

Pregnancy and breastfeeding

The mother should consider using adequate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Humira.
If the mother is pregnant, suspects she may be pregnant or is planning a pregnancy, she should ask her doctor for advice about taking this medicine.
Humira should only be used during pregnancy if necessary.
According to a pregnancy study, no increased risk of birth defects was found when the mother had received Humira during pregnancy, compared to mothers who had the same condition but had not received Humira.
Humira can be used during breastfeeding.
If the mother has taken Humira during pregnancy, her child may have a higher risk of contracting an infection.
It is important to inform the pediatrician and other healthcare professionals about the use of Humira during pregnancy, before the child receives any vaccinations. For more information on vaccinations, see “Warnings and precautions”.

Driving and using machines
Humira may affect, although only to a modest extent, your child’s ability to drive, ride a
bicycle or use machines. After taking Humira, you may experience visual disturbances and a sensation that the environment around you is spinning.

3. How to use Humira

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts or require clarification, consult your doctor or pharmacist.
The recommended doses of Humira for each approved indication are listed in the following
table. The doctor may prescribe a different concentration of Humira if the child needs a
different dose.

Juvenile Idiopathic Polyarthritis
Age or body weight	a How much should be taken and how often?	Notes
Children, adolescents and adults aged 2 years and over and weighing 30 kg or more	I 40 mg every other week	Not applicable
a Children and adolescents aged 2 i years and over and weighing between 10 kg and less than 30 kg	20 mg every other week	Not applicable

Enthesitis-related Arthritis
n Age or body weight	How much should be taken and how often?	Notes
e g Children, adolescents and adults aged 6 years and over and weighing 30 kg or more	40 mg every other week	Not applicable
A Children and adolescents aged 6 years and over and weighing between 15 kg and less than 30 kg	20 mg every other week	Not applicable

Plaque Psoriasis in Pediatric Patients
Age or body weight	How much should be taken and how often?	Notes
Children and adolescents aged between 4 and 17 years and weighing 30 kg or more	An initial dose of 40 mg, followed by 40 mg after one week. Subsequently, the usual dose is 40 mg every other week.	o Not applicable c a
Children and adolescents aged between 4 and 17 years and weighing between 15 kg and less than 30 kg	An initial dose of 20 mg, followed by 20 mg after one week. Subsequently, the usual dose is 20 mg every other week.	m Not applicable r a F

Crohn’s Disease in Pediatric Patients
Age or body weight	l How much should be taken and how often?	Notes
Children and adolescents aged between 6 and 17 years weighing 40 kg or more	e d An initial dose of 80 mg followed by 40 mg after two weeks. a If a faster response is needed, the pediatrician may prescribe an initial dose of 160 mg, followed by 80 mg after two weeks. i Subsequently, the usual dose is 40 mg every other week.	The pediatrician may increase the dosage to 40 mg every week or 80 mg every other week.
Children and adolescents aged between 6 and 17 years weighing less than 40 kg a i z n	a An initial dose of 40 mg t followed by 20 mg after two I weeks. If a faster response is needed, the pediatrician may prescribe an initial dose of 80 mg, followed by 40 mg after two weeks. Subsequently, the usual dose is 20 mg every other week.	The pediatrician may increase the frequency of the dose to 20 mg every week.

Pediatric Uveitis
g Age or body weight	How much should be taken and how often?	Notes
A Children and adolescents aged 2 years and over and weighing less than 30 kg	20 mg every other week	The doctor may prescribe an initial dose of 40 mg to be administered one week before the start of the usual dose of 20 mg every other week. The use of Humira is

Method and route of administration
Humira is administered by subcutaneous injection (under the skin).

Detailed instructions for injecting Humira can be found in section 7 “Humira Injection”.
If you use more Humira than you should
If you accidentally inject Humira more frequently than prescribed by your doctor or pharmacist,
contact your doctor or pharmacist informing them that the child has taken more medicine. Always keep the medicine box, even if empty.

If you forget to use Humira
If you forget to give an injection to the child, you should inject the next dose as soon as you remember.
Then give the child the next dose regularly according to the established dosage schedule.

If you stop treatment with Humira
The decision to stop using Humira should be discussed with your doctor. The child’s symptoms
may return if you stop treatment with Humira.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate in form. However, some may be serious and require treatment. Side effects may occur
up to 4 months after the last injection of Humira.

Immediately inform your doctor if you notice any of the following reactions

severe skin rash, hives or other signs of an allergic reaction
swelling of the face, hands, feet
difficulty breathing, difficulty swallowing
shortness of breath during physical activity or when lying down or swollen feet

Inform your doctor as soon as possible if you notice any of the following reactions

signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating
fatigue or weakness
cough
tingling

		recommended in association with methotrexate.
Children and adolescents from 2 years of age and weighing equal to or greater than 30 kg	40 mg every other week	or The doctor may prescribe an initial dose of 80 mg to be a administered one week before starting the usual 40 mg dose every other week. The use of Humira is recommended in association with methotrexate.

numbness
double vision
weakness of the arms or legs
swelling or open sore that does not heal
signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, pallor

The symptoms described above may be signs of the following side effects, which have been observed
with Humira.

Very common(may affect more than 1 in 10 people)

reactions at the injection site (including pain, swelling, redness or itching)
respiratory tract infections (including cold, runny nose, sinusitis and pneumonia)
headache
abdominal pain
nausea and vomiting
skin rash
musculoskeletal pain

Common(may affect up to 1 in 10 people)

serious infections (including sepsis and influenza)
intestinal infections (including gastroenteritis)
skin infections (including cellulitis and Herpes Zoster infection)
ear infections
oral infections (including dental infections and herpes simplex)
reproductive system infections
urinary tract infections
fungal infections
infections of the joints
benign tumors
skin cancer
allergic reactions (including seasonal allergies)
dehydration
mood changes (including depression)
anxiety
sleep disorders
sensory disturbances such as tingling, stabbing sensation or numbness
migraine
nerve root compression (including lower back pain and leg pain)
visual disturbances
eye inflammation
eyelid inflammation and eye swelling
dizziness (feeling faint or lightheaded)
fast heartbeat
high blood pressure
hot flashes
bruising (blood accumulation outside of blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heartburn)
acid reflux
dry eye syndrome (including dry eyes and dry mouth)
itching
itchy skin rash
contusion
skin inflammation (such as eczema)
nail breakage of the fingers and toes
increased sweating
hair loss
onset or worsening of psoriasis
muscle spasms
blood in urine
kidney problems
chest pain
edema (swelling)
fever
reduced platelets in the blood, which increases the risk of bleeding or bruising
difficulty healing wounds

Uncommon(may affect up to 1 in 100 people)

opportunistic infections (including tuberculosis and other infections that occur when immune defenses are reduced)
neurological infections (including viral meningitis)
eye infections
bacterial infections
diverticulitis (inflammation and infection of the large intestine)
tumors
tumors of the lymphatic system
melanoma
immune system disorders that can affect the lungs, skin and lymph nodes (which most commonly present as sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (nerve damage)
stroke
hearing loss, tinnitus
irregular heartbeat such as palpitations
heart problems that can cause shortness of breath or swelling of the ankles
acute myocardial infarction
formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel
lung disease causing shortness of breath (including inflammation)
pulmonary embolism (blockage of a pulmonary artery)
pleural effusion (abnormal accumulation of fluid in the pleural space)
inflammation of the pancreas causing severe pain in the abdomen and back
difficulty swallowing
facial edema (swelling of the face)
inflammation of the gallbladder, gallstones
fatty liver
night sweats
scarring
abnormal muscle catabolism
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs)
interrupted sleep
impotence
inflammations

Rare(may affect up to 1 in 1,000 people)

leukemia (a cancer that affects the blood and bone marrow)
severe allergic reaction with shock
multiple sclerosis
neurological disorders (such as optic nerve inflammation and Guillain-Barré syndrome, which can cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
cardiac arrest
pulmonary fibrosis (scarring of the lungs)
intestinal perforation (hole in the intestine)
hepatitis
reactivation of hepatitis B
autoimmune hepatitis (inflammation of the liver caused by your own immune system)
cutaneous vasculitis (inflammation of the blood vessels in the skin)
Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash)
facial edema (swelling of the face) associated with allergic reactions
multiforme erythema (inflammatory skin rash)
lupus-like syndrome
angioedema (localized swelling of the skin)
lichenoid skin reaction (itchy reddish-purple rash)

Not known(frequency cannot be estimated based on available data)

T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal)
Merkel cell carcinoma (a type of skin cancer)
Kaposi's sarcoma, a rare cancer associated with human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness)
Weight gain (weight gain has been small for most patients)

Some of the effects observed with Humira may be asymptomatic and can only be detected
through blood tests. These include:

Very common(may affect more than 1 in 10 people)

low white blood cell count
low red blood cell count
increased lipids in the blood
increased liver enzymes

Common(may affect up to 1 in 10 people)

serious infections
increased white blood cell count
decreased platelet count
increased uric acid in the blood
altered sodium in the blood
decreased calcium in the blood
decreased phosphorus in the blood
increased sugar in the blood
increased lactate dehydrogenase in the blood
presence of autoantibodies in the blood
decreased potassium in the blood

Uncommon(may affect up to 1 in 100 people)

high levels of bilirubin in the blood (liver blood test)

Rare(may affect up to 1 in 1,000 people)

low white blood cell count, red blood cell count and platelets

Reporting of side effects
If your child experiences any side effects, including those not listed in this leaflet,
contact your pediatrician or pharmacist. You can also report side effects directly through the
national reporting system reported in Annex V. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Humira

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2  C – 8  C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled syringe may be stored
at room temperature (up to 25°C) for a maximum period of 14 days – ensure the
medicine is protected from light. Once removed from the refrigerator for storage at room
temperature, the syringe must be used within 14 days or discarded, even if it is placed back in the
refrigerator.
You must record the date on which the syringe is removed from the refrigerator for the first time and the date after which
the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor or pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humira contains
The active substance is adalimumab.
The excipients are mannitol, polysorbate 80 and water for injections.

Description of the appearance of Humira pre-filled syringe and contents of the pack
Humira 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as a sterile
solution of 20 mg of adalimumab dissolved in 0.2 ml of solution.
The pre-filled syringe of Humira is a single-use glass syringe containing a solution of
adalimumab.
The pre-filled syringe of Humira is available in a pack containing 2 pre-filled syringes
with 2 alcohol swabs.
Humira may be available in vial, pre-filled syringe and/or pre-filled pen.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/ .

large> or
authorisation holder.

7. Humira Injection

The following instructions explain how to give the child a subcutaneous injection of Humira using the pre-filled syringe. First read the instructions carefully and follow them step by step.
You will receive instructions from your doctor, nurse or pharmacist on the technique for administering the injection.
Do not proceed with the injection on the child until you are sure you understand how to prepare and administer the injection.
After adequate instruction, the injection can be performed by the child or by another person such as, for example, a family member or friend.
Use each pre-filled syringe exclusively for one injection only.

Humira pre-filled syringe
PlungerFinger gripNeedle cap

Gray syringe with plunger and metal needle, arrows indicating the main parts

Do not use the pre-filled syringe and contact your doctor or pharmacist if

the solution appears cloudy, has changed color, or contains flocculi and particles
the expiry date (Exp.) has been exceeded
the solution has been frozen or exposed to direct sunlight
the pre-filled syringe has been dropped or damaged

Only remove the needle cap immediately before the injection. Keep Humira out of the
sight and reach of children.
STEP 1
Remove Humira from the refrigerator.
Before giving the injection, allow Humira to reach room temperature for 15-30 minutes.

Do notremove the needle cap while waiting for Humira to reach room temperature
Do notwarm Humira in other ways. For example, do notwarm in the microwave or in hot water. STEP 2Check the expiry date (Exp.). Do notuse the pre-filled syringe if the expiry date (Exp.) has been exceeded.

Arrange the following items on a clean, flat surface

Syringe

1 single-use pre-filled syringe
1 alcohol swab

Wash and dry your hands.

Prefilled syringe in blister packaging with space for l

Swab
STEP 3
Injection areas
Choose an injection site:

On the front of the child's thigh or
On the child's abdomen (belly) at least 5 cm from the navel
At least 3 cm from the child's last injection site

Rub the injection site with circular movements,
using the alcohol swab.

Person with adhesive bandages applied to abdomen and hips, close-up detail of a hand applying a bandage

Do notinject through clothing
Do notinject into areas where the skin appears red or hardened, there are bruises, ulcers, scars, stretch marks or areas with plaque psoriasis

Injection areas
STEP 4Hold the pre-filled syringe with one hand.
Check the liquid in the pre-filled syringe.

Make sure the liquid is clear and colorless
Do notuse the pre-filled syringe if the liquid is cloudy or contains particles
Do notuse the pre-filled syringe if it has been dropped or crushed

Gently remove the cap from the syringe needle with
your other hand. Dispose of the cap. Do not reuse the cap.

Hand holding a pre-filled syringe with exposed needle and a separate protective cap next to it

Do nottouch the needle with your fingers, and make sure the needle does not come into contact with anything. STEP 5Hold the pre-filled syringe with the needle pointing upwards.

Hand holding an injection device with a transparent needle and a cross-shaped support for l

Hold the pre-filled syringe at eye level with one hand, so you can see the air in the pre-filled syringe

Slowly push the plunger to expel the air through
the needle.

It is normal to see a drop of liquid at the end of the needle

STEP 6Hold the pre-filled syringe with one hand between your thumb and
index finger, like a pencil.
With your other hand, grasp the skin at the injection
site to lift it and hold it firmly

STEP 7Insert the needle completely into the skin at
an angle of approximately 45° with a quick and
decisive movement.

Subcutaneous injection with a syringe at 45 degrees in the arm, detail of the needle penetrating the skin and angle indicated with a triangle

When the needle is inserted, release the skin.

Push the plunger completely until all the
liquid has been injected and the pre-filled syringe is empty.

STEP 8When the syringe is empty, slowly remove the needle from
the skin, keeping the same angle as when it was
inserted.
After giving the injection, press a cotton ball or
gauze onto the skin at the injection site.

Subcutaneous injection with a syringe: hand holding the syringe and l

Do notrub
It is normal for slight bleeding to occur at the injection site

Cotton ball
STEP 9
Dispose of the used pre-filled syringe in a special container, according to the instructions of your doctor,
nurse or pharmacist. Never recap the needle.

Do notrecycle or dispose of the pre-filled syringe in household waste
Always keep the pre-filled syringe and the special waste container out of the sight and reach of children.

The needle cap, alcohol swab, cotton ball or gauze, blister and
packaging can be disposed of in household waste.

Humira 40 mg/0.8 ml injectable solution

adalimumab

Read this leaflet carefully before the child starts using this medicine because
it contains important information

Keep this leaflet. You may need to read it again.
The doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before the child is given Humira and during treatment with Humira. You or the child keep this Patient Reminder Card.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed only for the child. Do not give it to other people, even if their symptoms are the same as those of the child, because it could be dangerous.
If the child experiences any side effects, including those not listed in this leaflet, contact the pediatrician or pharmacist. See section 4.

Contents of this leaflet:

1. What Humira is and what it is used for
2. What you need to know before the child uses Humira
3. How to use Humira
4. Possible side effects
5. How to store Humira
6. Contents of the pack and other information

1. What is Humira and what is it used for

Humira contains the active ingredient adalimumab.
Humira is indicated for the treatment of the inflammatory diseases listed below:

Juvenile idiopathic polyarticular arthritis
Arthritis associated with enthesitis
Pediatric plaque psoriasis
Hidradenitis suppurativa in adolescents
Crohn’s disease in pediatric patients
Ulcerative colitis in pediatric patients
Pediatric uveitis

2. What you need to know before your child uses Humira

Do not use Humira

If your child is allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
If there is a serious infection, including active tuberculosis (see “Warnings and precautions”). It is important to tell your doctor if your child has symptoms of infection, such as e.g. fever, wounds, feeling tired, dental problems.
If there is moderate or severe heart failure. It is important to tell your doctor if there has been or is a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your pediatrician or pharmacist before using Humira.

If there are allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not give Humira again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.
If there is an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Humira. If you have doubts, contact your doctor.
It is possible to contract infections more easily during treatment with Humira. This risk may increase if your child's lung function is impaired. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis which, in rare cases, can be life-threatening to the patient. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise temporarily stopping Humira.
Since cases of tuberculosis have occurred in patients treated with Humira, your doctor will need to check if your child presents signs or symptoms typical of tuberculosis before starting therapy with Humira. This will involve collecting a detailed medical assessment including your child's medical history and appropriate clinical examinations (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if your child has ever had tuberculosis, or if they have had close contact with people with tuberculosis. Tuberculosis may develop during therapy even if the child has received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.
Tell your doctor if your child lives in or travels to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are endemic.
Tell your doctor if your child has had recurrent infections or if they have conditions that increase the risk of infection.
Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if they have an active infection with the hepatitis B virus or if you think they may be at risk of contracting the hepatitis B virus. Your doctor should test your child for hepatitis B virus infection. Taking Humira may cause reactivation of the hepatitis B virus in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of the hepatitis B virus can be life-threatening to the patient.
It is important to inform your pediatrician if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.
Before surgery or dental procedures, tell your doctor that your child is taking Humira. Your doctor may advise temporarily stopping it.
If your child suffers from or develops demyelinating diseases such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Humira. Tell your doctor immediately if your child experiences symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.
Certain vaccines can cause infections and should not be given during treatment with Humira. Consult your doctor before vaccinating your child. In children, it is advisable, if possible, to implement the vaccination schedule before starting therapy with Humira, in compliance with current vaccination guidelines. If you have taken Humira during pregnancy, your child may have a higher risk of contracting such an infection up to about 5 months after the last dose you took during pregnancy. It is important that you tell your pediatrician or other healthcare provider about your use of Humira during pregnancy, so that they can decide when your child should receive any type of vaccination.
In case of mild heart failure and concomitant treatment with Humira, the doctor must carefully evaluate and monitor the child's heart condition. It is important to inform the doctor about any heart problems, both past and present. If new symptoms of heart failure appear or existing symptoms worsen (e.g., shortness of breath or swelling of the feet), contact your doctor immediately. The doctor will decide if the child can take Humira.
In some patients, the body may not be able to produce enough blood cells to help them fight infections or stop bleeding. If your child has persistent fever, bruising or easy bleeding, or paleness, see your doctor immediately. The latter may decide to interrupt the therapy.
In patients, both children and adults, undergoing treatment with Humira or with other anti-TNF drugs, very rare cases of certain types of tumors have occurred. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukemia (a cancer affecting the blood and bone marrow). If your child takes Humira, the risk of developing lymphomas, leukemia or other tumors may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with Humira. Some of these patients were also being treated with azathioprine or 6-mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira. In addition, cases of non-melanoma skin cancer have been observed in patients taking Humira. If new skin lesions appear during or after therapy or if the appearance of existing lesions changes, report it to your doctor.
There have been cases of neoplasms, other than lymphoma, in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another anti-TNF. If your child suffers from COPD, or smokes heavily, they should discuss with their doctor whether treatment with an anti-TNF is appropriate.
Rarely, treatment with Humira can lead to the manifestation of a syndrome like lupus. Tell your doctor if symptoms such as a persistent unexplained rash, fever, joint pain or fatigue appear.

Other medicines and Humira
Tell your pediatrician or pharmacist if your child is taking, has recently taken or might
take any other medicines.
Humira can be taken both with methotrexate and with other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), steroids or
analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Humira must not be taken at the same time as medicines containing anakinra or abatacept as the active ingredient due to the increased risk of serious infections. If you have doubts, consult your doctor.

Pregnancy and breastfeeding

The girl should consider using adequate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Humira.
If the girl is pregnant, suspects she is pregnant or is planning a pregnancy, she should ask her doctor for advice on taking this medicine.
Humira should only be used during pregnancy if necessary.
According to a pregnancy study, no increased risk of birth defects was found when the mother had received Humira during pregnancy, compared to mothers with the same condition who had not received Humira.
Humira can be used during breastfeeding.
If the girl takes Humira during pregnancy, the child may have a higher risk of contracting an infection.
It is important that you tell your pediatrician or other healthcare provider about the use of Humira during pregnancy, before the child receives any type of vaccine. For more information on vaccinations, see “Warnings and precautions”.

Driving and using machines
Humira may affect, albeit only to a modest extent, the ability to drive, ride a bicycle or
use machines. After taking Humira, you may experience vision disturbances and a
sensation that the environment around you is rotating.

Humira contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml of dose, i.e. essentially
‘sodium-free’.

3. Come usare Humira

Usi questo medicinale seguendo sempre esattamente le istruzioni del pediatra o del farmacista. Se ha
dubbi o desidera chiarimenti consulti il pediatra o il farmacista. Il medico potrebbe prescrivere un’altra
concentrazione di Humira se il bambino necessita di una dose differente.
Bambini e adolescenti con artrite idiopatica giovanile poliarticolare

Bambini e adolescenti a partire da 2 anni di età e con peso compreso tra 10 kg e meno di 30 kg
La dose raccomandata di Humira è 20 mg a settimane alterne.

Bambini e adolescenti a partire da 2 anni di età e con peso uguale o superiore a 30 kg
La dose raccomandata di Humira è 40 mg a settimane alterne.
Bambini, adolescenti e adulti con artrite associata ad entesite

Bambini e adolescenti a partire da 6 anni di età e con peso compreso tra 15 kg e meno di 30 kg
La dose raccomandata di Humira è 20 mg a settimane alterne.

Bambini, adolescenti e adulti a partire da 6 anni di età e con peso uguale o superiore a 30 kg
La dose raccomandata di Humira è 40 mg a settimane alterne.
Bambini e adolescenti con psoriasi

Bambini e adolescenti di età compresa tra 4 e 17 anni e con peso compreso tra 15 kg e meno di 30 kg
La dose raccomandata di Humira è una dose iniziale di 20 mg, seguita da una dose di 20 mg la
settimana seguente. Successivamente, la dose abituale è di 20 mg a settimane alterne.

Bambini e adolescenti di età compresa tra 6 e 17 anni e con peso inferiore a 40 kg
La dose abituale è inizialmente di 40 mg seguita da 20 mg dopo due settimane. Nel caso sia necessaria
una risposta più rapida, il pediatra può prescrivere una dose iniziale di 80 mg (tramite due iniezioni da
40 mg in un giorno) seguita da 40 mg due settimane dopo.
Successivamente, la dose abituale è di 20 mg a settimane alterne. In funzione della risposta del
bambino, il pediatra può aumentare la frequenza della dose a 20 mg ogni settimana.

Bambini e adolescenti di età compresa tra 6 e 17 anni e con peso uguale o superiore a 40 kg
La dose abituale è inizialmente di 80 mg (tramite due iniezioni da 40 mg in un giorno) seguita da 40
mg dopo due settimane. Nel caso sia necessaria una risposta più rapida, il pediatra può prescrivere una
dose iniziale di 160 mg (tramite quattro iniezioni da 40 mg in un giorno o due iniezioni da 40 mg al
giorno per due giorni consecutivi) seguita da 80 mg (tramite due iniezioni da 40 mg in un giorno) due
settimane dopo.
Successivamente, la dose abituale è di 40 mg a settimane alterne. In funzione della risposta del
bambino, il pediatra può aumentare il dosaggio a 40 mg ogni settimana o 80 mg a settimane alterne.
Bambini e adolescenti con colite ulcerosa

Bambini e adolescenti a partire dai 6 anni di età e con peso inferiore a 40 kg
La dose abituale di Humira è di 80 mg (tramite due iniezioni da 40 mg in un giorno) seguita da 40 mg
(tramite una sola iniezione da 40 mg) dopo due settimane. Successivamente, la dose abituale è di
40 mg a settimane alterne.
I pazienti che compiono 18 anni mentre assumono 40 mg a settimane alterne devono continuare la
dose prescritta.

Bambini e adolescenti a partire da 2 anni di età e con peso inferiore a 30 kg
La dose abituale di Humira è di 20 mg somministrati a settimane alterne con metotrexato.
Il pediatra potrebbe prescrivere anche una dose iniziale da 40 mg che potrebbe essere somministrata
una settimana prima dell’inizio della dose abituale.

Bambini e adolescenti a partire da 2 anni di età e con peso uguale o superiore a 30 kg
La dose abituale di Humira è di 40 mg somministrati a settimane alterne con metotrexato.
Il pediatra potrebbe prescrivere anche una dose iniziale da 80 mg che potrebbe essere somministrata
una settimana prima dell’inizio della dose abituale.

Modo e via di somministrazione
Humira è somministrato per iniezione sotto la cute (per iniezione sottocutanea).

Istruzioni per la preparazione e l’iniezione di Humira
Le seguenti istruzioni spiegano come iniettare Humira. Legga attentamente le istruzioni e le segua passo
dopo passo. Riceverà istruzioni dal medico o dal suo assistente sulla tecnica della somministrazione e
sulla quantità da somministrare al bambino. Non proceda all’iniezione finché non è sicuro di aver capito
come preparare ed eseguire la somministrazione. Dopo adeguate istruzioni l’iniezione può essere
eseguita da lei o da altre persone quali, ad esempio, un familiare o un amico.
La mancata esecuzione delle seguenti istruzioni, come descritto, può determinare una contaminazione
che potrebbe a sua volta causare infezioni al bambino.
Il contenuto della siringa non deve essere mescolato ad altri farmaci nella stessa siringa o nel flaconcino.

1)Preparazione

Si assicuri di conoscere la quantità appropriata (volume) necessaria per la dose. Se non conosce la quantità, SI FERMIe contatti il medico per ricevere ulteriori istruzioni.
Avrà necessità di un contenitore speciale per i rifiuti, come ad esempio un contenitore per oggetti appuntiti oppure come le viene indicato dall’infermiere, medico o farmacista. Disponga il contenitore sulla propria superficie di lavoro.
Si lavi accuratamente le mani.
Rimuova dall’astuccio una scatola contenente una siringa, un adattatore per flaconcini, un flaconcino, 2 tamponi imbevuti di alcool e un ago. Se c’è una seconda scatola nell’astuccio da utilizzare per la prossima somministrazione, la riponga nel frigorifero immediatamente.
Controlli la data di scadenza sulla scatola. NONultilizzi alcuno degli oggetti nella scatola dopo la data di scadenza.
Sistemi i seguenti oggetti su una superficie pulita, SENZAancora tirare fuori alcun oggetto dal suo confezionamento.

o Una siringa da 1 ml (1)
o Un adattatore per flaconcino (2)
o Un flaconcino per uso pediatrico di Humira soluzione iniettabile (3)
o Due tamponi imbevuti di alcool (4)
o Un ago (5)

Components of the medication: vial, pre-filled syringe, adapter and disinfectant wipes numbered from 1 to 5

Humira è un liquido limpido e incolore. NONutilizzarlo se il liquido è opaco, di colore alterato o presenta flocculazioni o particelle all’interno.

2)Preparazione della dose di Humira per l’iniezione

Istruzioni generali: NONdisfarsi di nessun oggetto fino a quando l’iniezione non è stata completata.

Preparare l’ago aprendo parzialmente la confezione dall’estremità più vicina al connettore giallo della siringa. Aprire la confezione quanto basta ad esporre il connettore giallo della siringa. Posare la confezione con il lato chiaro rivolto verso l’alto.

Hand extracting a sealed cartridge from an open package, containing a liquid medicine

Togliere il cappuccio di plastica dal flaconcino fino a vedere la cima del tappo del flaconcino.

Hand unscrewing the cap of a cylindrical transparent vial with a white arrow indicating the direction of rotation

Usare uno dei tamponi imbevuti di alcol per pulire il tappo del flaconcino. NONtoccare il tappo del flaconcino dopo averlo pulito con il tampone.
Rimuovere la copertura della confezione dell’adattatore per flaconcino senza tirarlo fuori dalla confezione.

Two hands assembling a transparent medical device with interlocking components

Tenere il flaconcino con il tappo a faccia in sù.
Con l’adattatore per flaconcini ancora nella confezione trasparente, attaccarlo al tappo del flaconcino spingendolo fino a quando l’adattatore non scatta.
Quando si è sicuri che l’adattatore è attaccato al flaconcino, tirare via la confezione dallo stesso.
Deporre gentilmente il flaconcino e l’adattatore su una superficie di lavoro pulita, facendo attenzione che non cada. NONtoccare l’adattatore.

Hands removing the protective cap from a vial and then drawing the medicine with a needle from a vial

Preparare la siringa aprendo parzialmente la confezione dall’estremità più vicina allo stantuffo bianco.
Aprire la confezione trasparente quanto basta ad esporre lo stantuffo bianco senza tirare fuori la siringa dalla sua confezione.
Mantenere la confezione della siringa, far uscire LENTAMENTElo stantuffo 0,1 ml al di sopra della dose prescritta (per esempio, se la dose prescritta è 0,5 ml, spingere lo stantuffo fino a 0,6 ml). Non superare MAIla posizione corrispondente a 0,9 ml indipendentemente dalla dose prescritta.
Il volume verrà regolato fino alla dose prescritta in un passaggio successivo.
NONspingere lo stantuffo bianco completamente fuori dalla siringa.

NOTA:
Se lo stantuffo bianco è spinto completamente fuori dalla siringa, scartare la siringa e contattare il
fornitore di Humira per la sostituzione. NONcercare di inserire nuovamente lo stantuffo bianco.

Dose + 0.1 mL

NONusare lo stantuffo bianco per rimuovere la siringa dalla confezione. Tenere la siringa sulla parte graduata e tirarla fuori dalla sua confezione. NONdeporre la siringa in nessun momento.
Tenendo fermo l’adattatore, inserire la punta della siringa all’interno dell’adattatore e girare la siringa in senso orario con una mano fino a che non è fermo. NONstringere troppo.

Tenendo il flaconcino, spingere lo stantuffo bianco fino in fondo. Questa fase è importante per prelevare la giusta dose. Tenere dentro lo stantuffo bianco e capovolgere il flaconcino e la siringa.

Hand holding a syringe and a vial, with an arrow indicating the direction of insertion of

Tirare LENTAMENTElo stantuffo bianco fino a 0,1 ml al di sopra della dose prescritta. È importante per prelevare la dose appropriata. Il liquido passerà dal flaconcino alla siringa.

Hand holding a syringe with needle while drawing the medicine from a transparent vial white arrow indicates direction of aspiration

Spingere indietro lo stantuffo bianco fino alla fine per far rientrare il liquido nel flaconcino. Di nuovo, tirare LENTAMENTElo stantuffo bianco fino a raggiungere 0,1 ml al di sopra della dose prescritta; è importante per prelevare la dose appropriata e prevenire la formazione di bolle d’aria nel liquido o spazi vuoti. Il volume equivalente alla dose prescritta sarà stabilito al punto 4, Preparazione della dose.

Hand holding a syringe with needle and transparent glass vial, preparing to

Se rimangono bolle d’aria o spazi vuoti nella siringa, può ripetere tale operazione fino a tre volte. NONscuotere la siringa.

NOTE:
If the white plunger is pushed completely out of the syringe, discard the syringe and contact your
Humira provider for a replacement. DO NOTtry to reinsert the white plunger.

Holding the syringe still in the upright position by the graduation, remove the adapter with the vial by unscrewing the adapter with your other hand. Make sure to remove the adapter with the vial from the syringe. DO NOTtouch the tip of the syringe.

Hand holding a prefilled syringe with a white arrow indicating the direction of injection and another arrow pointing downwards

If you notice a large air bubble or an empty space near the tip of the syringe, push the white plunger SLOWLYinto the syringe until fluid starts to enter the tip of the syringe. DO NOTpush the white plunger past the position corresponding to the dose.
For example, if the prescribed dose is 0.5 ml, DO NOTpush the white plunger past the 0.5 ml position.
Verify that the fluid remaining in the syringe is at least equivalent to the prescribed dose. If it is less, DO NOTuse the syringe and contact your healthcare provider.
With your free hand, pick up the needle pack with the yellow syringe connector facing downwards.
Keeping the syringe facing upwards, insert the tip of the syringe into the yellow connector and rotate the syringe as indicated by the arrow in the figure until it stops. The needle is now attached to the syringe.

Hand screwing a needle onto a prefilled syringe with a curved arrow indicating the rotation movement

Pull the needle out of the pack, but DO NOTremove the clear needle cap.
Place the syringe on a clean work surface. Proceed immediately with the injection site and dose preparation steps.

3)Choosing and preparing an injection site

Choose a site on the thigh or abdomen: DO NOTuse the same site that was used for the last injection.
The new injection must be administered at least 3 cm from the last injection site.

Diagram of the human body with a gray area indicating the abdominal injection zone and a medical device applied

DO NOTinject into areas where the skin appears red, bruised, or hardened. This may indicate an infection; therefore, you should contact your doctor.
To reduce the possibility of infection, rub the injection site with the other alcohol swab. DO NOTtouch the area again before the injection.

4)Preparing the dose

Pick up the syringe with the needle pointing upwards.
Use your other hand to turn the pink needle cover towards the syringe.

Hand grasping an auto-injector device with a visible needle and a curved arrow indicating the direction of injection

Remove the clear needle cap by pulling it upwards with your other hand.

The needle is clean.
DO NOTtouch the needle.
DO NOTpoint the syringe downwards after the clear needle cap has been removed.
DO NOTtry to put the clear needle cap back on the needle.
Hold the syringe at eye level with the needle pointing upwards to clearly see the amount of liquid. Be careful not to spray the medicine into your eyes.
Check the amount of medicine drawn up again.
Gently push the white plunger into the syringe until the syringe contains the prescribed amount of medicine. Excess liquid may leak from the needle while the plunger is pressed. DO NOTremove the needle or syringe.

5)Injecting Humira

With your free hand, gently grasp the area already rubbed with alcohol and hold it firm.
With your other hand, hold the syringe at a 45° angle to the injection site.
With a firm, quick motion, push the entire needle into the skin.
Release the skin with your hand.
Push the white plunger to inject the medicine until the syringe is empty.
When the syringe is empty, remove the needle from the skin by pulling it out at the same angle it was inserted.

Hand holding a syringe tilted at 45 degrees while injecting medication into a patient's arm with a cannula

Gently turn the pink needle cover upwards, over the needle, to snap it on, and place the syringe with the needle on the work surface. DO NOTput the clear needle cap back on the needle.

Hand holding a prefilled syringe with needle inserted into a valve connection device for infusion

With a piece of gauze, apply pressure to the injection site for 10 seconds. You may experience slight bleeding. DO NOTmassage the injection site. If desired, apply a bandage.

6)Disposing of materials

You will need a special waste container, such as a sharps container, or according to the instructions of your nurse, doctor, or pharmacist.
Place the syringe with the needle, the vial, and the adapter in a special sharps container. DO NOTput these items in your household trash container.
The syringe, needle, vial, and adapter SHOULD NEVERbe reused.
Keep this container always out of the sight and reach of children.
Dispose of all other materials used in the household trash container.

If you use more Humira than you should
If you accidentally inject more Humira than prescribed, or if you inject it more frequently than
directed by your doctor, contact your doctor informing them that the child has received more medication.
Always keep the medicine box or vial, even if empty.

If you use less Humira than you should
If you accidentally inject less Humira than prescribed, or if you inject it less frequently than
directed by your pediatrician or pharmacist, contact your pediatrician or pharmacist informing them that the
child has received less medication. Always keep the medicine box or vial, even if
empty.

If you forget to use Humira
If you forget to give your child an injection of Humira, you should inject the missed dose of Humira as soon as you
remember. Then administer the next dose to your child regularly according to the established dosing schedule.

If your child stops treatment with Humira
The decision to stop using Humira should be discussed with your pediatrician. The child's symptoms
may return after discontinuation.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

severe skin rash, hives or other signs of an allergic reaction;
swelling of the face, hands, feet;
difficulty breathing, difficulty swallowing;
shortness of breath on exertion or when lying down or swollen feet.

Inform your doctor as soon as possible if you notice any of the following reactions

signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating;
fatigue or weakness;
cough;
tingling;
numbness;
double vision;
weakness of the arms or legs;
swelling or open sore that does not heal
signs and symptoms suggesting the onset of disorders affecting the hematopoietic system, such as persistent fever, bruising, bleeding, pallor.

The symptoms described above may be signs of the following side effects, which have been observed
with Humira.
Very common (may affect more than 1 in 10 people)

reactions at the injection site (including pain, edema, redness or itching);
respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
headache;
abdominal pain;
nausea and vomiting;
skin rash;
musculoskeletal pain.

Common (may affect up to 1 in 10 people)

serious infections (including sepsis and influenza);
intestinal infections (including gastroenteritis);
skin infections (including cellulitis and Herpes Zoster infection);
ear infections;
oral infections (including dental infections and herpes simplex);
infections of the reproductive system;
urinary tract infections;
fungal infections;
infections affecting the joints;
benign tumors;
skin cancer;
allergic reactions (including seasonal allergies);
dehydration;
mood changes (including depression);
anxiety;
sleep disorders;
sensory disturbances such as tingling, stabbing sensation or numbness;
migraine;
nerve root compression (including lower back pain and leg pain);
visual disturbances;
eye inflammation;
inflammation of the eyelids and swelling of the eyes;
dizziness;
feeling of a racing heartbeat;
high blood pressure;
hot flashes;
bruising;
cough;
asthma;
shortness of breath;
gastrointestinal bleeding;
dyspepsia (indigestion, bloating, heartburn);
acid reflux;
dry eye syndrome (including dry eyes and dry mouth);
itching;
itchy skin rash;
contusion;
skin inflammation (such as eczema);
nail breakage of the fingers and toes;
increased sweating;
hair loss;
onset or worsening of psoriasis;
muscle spasms;
blood in the urine;
kidney problems;
chest pain;
edema;
fever;
reduced platelets in the blood, which increases the risk of bleeding or bruising;
difficulty healing wounds.

Uncommon (may affect up to 1 in 100 people)

opportunistic infections (including tuberculosis and other infections that occur when immune defenses are reduced);
neurological infections (including viral meningitis);
eye infections;
bacterial infections;
diverticulitis (inflammation and infection of the large intestine);
tumors;
tumors of the lymphatic system;
melanoma;
immune system disorders that can affect the lungs, skin and lymph nodes (which most commonly present as sarcoidosis);
vasculitis (inflammation of blood vessels);
tremor;
stroke;
neuropathy;
hearing loss, tinnitus;
feeling of irregular heartbeat such as palpitations;
heart problems that can cause shortness of breath or swelling at the level of the ankles;
acute myocardial infarction;
formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
lung disease that causes shortness of breath (including inflammation);
pulmonary embolism (blockage of a pulmonary artery);
pleural effusion (abnormal collection of fluid in the pleural space);
inflammation of the pancreas that causes severe pain in the abdomen and back;
difficulty swallowing;
facial edema;
inflammation of the gallbladder, gallstones;
fatty liver;
night sweats;
scarring;
abnormal muscle catabolism;
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs)
interrupted sleep;
impotence;
inflammations.

Rare (may affect up to 1 in 1,000 people)

leukemia (a cancer that affects the blood and bone marrow);
severe allergic reaction with shock;
multiple sclerosis;
neurological disorders (such as optic nerve inflammation and Guillain-Barré syndrome, which can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
cardiac arrest;
pulmonary fibrosis (scarring of the lungs);
intestinal perforation;
hepatitis;
reactivation of hepatitis B;
autoimmune hepatitis (inflammation of the liver caused by your own immune system);
cutaneous vasculitis (inflammation of the blood vessels of the skin);
Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and skin rash);
facial edema associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus-like syndrome;
angioedema (localized swelling of the skin);
lichenoid skin reaction (itchy red-violet rash).

Not known (frequency cannot be estimated based on available data)

T-cell hepato-splenic lymphoma (a rare blood cancer that is often fatal);
Merkel cell carcinoma (a type of skin cancer);
Kaposi's sarcoma, a rare cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
liver failure;
worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
Weight gain (weight gain has been low for most patients)

Some of the side effects observed with Humira may be asymptomatic and can only be
identified through blood tests.
These include:
Very common (may affect more than 1 in 10 people)

low white blood cell count;
low red blood cell count;
increased lipids in the blood;
increased liver enzymes.

Common (may affect up to 1 in 10 people)

increased white blood cell count;
reduced platelet count;
increased uric acid in the blood;
alteration of sodium in the blood;
reduced calcium in the blood;
reduced phosphorus in the blood;
increased sugar in the blood;
increased lactate dehydrogenase in the blood;
presence of autoantibodies in the blood;
reduced potassium in the blood.

Uncommon(may affect up to 1 in 100 people)

high levels of bilirubin in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

low white blood cell, red blood cell and platelet counts.

5. How to store Humira

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word ‘Expiry’.
Store in a refrigerator (2  C – 8  C). Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your doctor or pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humira contains

The active ingredient is adalimumab.
The excipients are mannitol, citric acid monohydrate, sodium citrate, sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.

Description of the appearance of Humira vials and contents of the pack
Humira 40 mg solution for injection in vials is supplied as a sterile solution of 40 mg of
adalimumab dissolved in 0.8 ml of solution.
Humira vials consist of a solution of adalimumab contained in a glass vial. One
pack contains 2 cartons, each of which contains 1 vial, a sterile empty syringe, 1 needle,
1 vial adapter and 2 alcohol swabs.
Humira may be available in vial, pre-filled syringe and/or pre-filled pen.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/ .

greater> or
authorisation holder.

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Humira 40 mg injectable solution in pre-filled syringe

adalimumab

Read this leaflet carefully before using this medicine as it contains important
information for you

Keep this leaflet. You may need to read it again.
Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before administering Humira and during treatment with Humira. Keep this Patient Reminder Card.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Humira is and what it is used for
2. What you need to know before you use Humira
3. How to use Humira
4. Possible side effects
5. How to store Humira
6. Contents of the pack and other information

1. What is Humira and what is it used for

Humira contains the active ingredient adalimumab.
Humira is indicated for the treatment of the inflammatory diseases listed below:

Rheumatoid arthritis,
Polyarticular juvenile idiopathic arthritis,
Arthritis associated with enthesitis,
Ankylosing spondylitis,
Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
Psoriatic arthritis,
Psoriasis,
Hidradenitis suppurativa,
Crohn’s disease,
Ulcerative colitis and
Non-infectious uveitis

The active ingredient contained in Humira, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system (defense) and is present in higher concentrations in the
inflammatory diseases listed above. By binding to TNFα, Humira decreases the inflammatory
process of these diseases.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Humira is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs, such as
methotrexate, may initially be taken. If the response to these drugs is not satisfactory,
you will be given Humira to treat rheumatoid arthritis.
Humira can also be used to treat severe, active and progressive rheumatoid arthritis
without prior treatment with methotrexate.
Humira has been shown to slow the progression of cartilage and bone damage in the
joints caused by the disease, and to improve physical function.
Generally Humira is used with methotrexate. If the doctor decides that treatment with
methotrexate is not appropriate, Humira can be administered alone.
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis are inflammatory
diseases.
Humira is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents of
ages 2 to 17 years and arthritis associated with enthesitis in children and adolescents of 6-17 years of age.
Other disease-modifying drugs, such as methotrexate, may be given at diagnosis.
If the response to these drugs is not adequate, you will be given Humira for the
treatment of polyarticular juvenile idiopathic arthritis or arthritis associated with enthesitis.
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis are inflammations of the spine.
Humira is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic
evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial
spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first take other
medications. If you are unable to achieve an adequate response with these medications, you will take
Humira to reduce the signs and symptoms of the disease.
Psoriatic arthritis
Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
Humira is used to treat psoriatic arthritis in adults. Humira has been shown to slow
the damage to the cartilage and bones of the joints caused by the disease, and to improve
physical function.
Plaque psoriasis in adults and children
Plaque psoriasis is a skin condition that causes red, scaly, and hardened patches of
skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to
break, thicken, and lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a
problem with the body's immune system that leads to increased
skin cell production.
Humira is used to treat moderate to severe plaque psoriasis in adults. Humira is
also used to treat severe plaque psoriasis in children and adolescents from 4 to 17 years of age
in whom topical therapy and phototherapy have not worked optimally or are not indicated.
Hidradenitis Suppurativa in adults and adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a chronic inflammatory disease of
the skin and is often painful. Symptoms may include painful nodules and abscesses (cysts) that can
drain pus. It most frequently affects specific areas of the skin, such as the submammary region,
the armpits, the inner thighs, the groin, and the buttocks. Scars can also form in the affected areas.
Humira is used to treat Hidradenitis Suppurativa in adults and adolescents from 12 years of
age. Humira can reduce the number of nodules and abscesses you have and the pain that is often associated with
this disease. Initially, you may receive other medications. If you do not respond well enough
to these medications, you will receive Humira.
Crohn’s disease in adults and children
Crohn’s disease is an inflammation of the digestive tract.
Humira is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If
you suffer from Crohn’s disease, you will first be given other medications. If you do not
respond adequately to these medications, you will be given Humira to
reduce the typical symptoms of Crohn’s disease.
Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine.
Humira is used to treat moderate to severe ulcerative colitis in adults and children aged 6
to 17 years. If you have ulcerative colitis, you may initially take other medications. If you
are unable to achieve an adequate response with these medications, you will take Humira to reduce
the signs and symptoms of the disease.
Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Humira is used for the treatment of:

Adults with non-infectious uveitis with inflammation affecting the back of the eye
Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation can lead to a decrease in vision and/or the presence of mobile bodies
in the eye (black spots or thin lines that move across the field of vision). Humira works
by reducing this inflammation.

2. What you need to know before using Humira

Do not use Humira

If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
If you have a severe infection, including active tuberculosis (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, dental problems.
If you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Humira

If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Humira again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.
If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Humira. If you have doubts, contact your doctor.
You may be more likely to get infections during treatment with Humira. This risk may increase if your lung function is impaired. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis which, in rare cases, can be life-threatening. It is important to tell your doctor about the presence of symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise temporarily stopping Humira.
Because cases of tuberculosis have occurred in patients treated with Humira, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Humira. This will involve collecting a detailed medical assessment including your medical history and appropriate clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis may develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.
Tell your doctor if you live in or travel to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.
Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active hepatitis B virus infection, or if you think you may be at risk of contracting the hepatitis virus

B. Your doctor should test you for hepatitis B virus infection. Taking Humira may cause reactivation of the hepatitis B virus in carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of the hepatitis B virus can be life-threatening.

If you are over 65 years of age, you may be more susceptible to infections while taking Humira. You and your doctor should pay particular attention to signs of infection while you are being treated with Humira. It is important to inform your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.
Before surgery or dental procedures, tell your doctor that you are taking Humira. Your doctor may advise temporarily stopping treatment.
If you have or develop demyelinating diseases such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Humira. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.
Certain vaccines can cause infections and should not be given during treatment with Humira. Consult your doctor before getting vaccinated. In children, it is recommended, if possible, to implement the vaccination schedule before starting therapy with Humira, in accordance with current vaccination guidelines. If you have taken Humira during pregnancy, the child may have a higher risk of contracting such an infection up to about 5 months after the last dose you took during pregnancy. It is important that you inform your pediatrician or other healthcare provider of your use of Humira during pregnancy, so that they can decide when the child should receive any type of vaccination.
In case of mild heart failure and concomitant treatment with Humira, the doctor must carefully assess and monitor the state of your heart. It is important to inform your doctor about any heart problems, both past and present. If new symptoms of heart failure appear or existing symptoms worsen (for example, shortness of breath or swelling of the feet), contact your doctor immediately. The doctor will decide if you can take Humira.
In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you have persistent fever, bruising or easy bleeding, or paleness, see your doctor immediately. The latter may decide to interrupt the therapy.
In patients, both children and adults, undergoing treatment with Humira or other anti-TNF drugs, very rare cases of certain types of tumors have occurred. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow). If you take Humira, your risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients undergoing therapy with Humira. Some of these patients were also being treated with azathioprine or 6-mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira. In addition, cases of non-melanoma skin cancer have been observed in patients taking Humira. If new skin lesions appear during or after therapy or if the appearance of existing lesions changes, report it to your doctor.
There have been cases of neoplasms, in addition to lymphoma, in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another anti-TNF. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNF is appropriate.
Rarely, treatment with Humira can lead to the manifestation of a syndrome like lupus. Tell your doctor if you develop symptoms such as persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

Vaccinations: if possible, children should have already received all vaccinations before using Humira.
Do not give Humira to children with polyarticular juvenile idiopathic arthritis under the age of 2 years.

Other medicines and Humira

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Humira can be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), steroids or analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Humira must not be taken at the same time as medicines containing the active ingredients anakinra or abatacept due to the increased risk of serious infections. If you have doubts, consult your doctor.

Pregnancy and breastfeeding

You should consider using appropriate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Humira.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice on taking this medicine.
Humira should only be used during pregnancy if necessary.
According to a pregnancy study, no increased risk of birth defects was found when the mother had received Humira during pregnancy, compared to mothers with the same condition who had not received Humira.
Humira can be used during breastfeeding.
If you take Humira during pregnancy, the child may have a higher risk of contracting an infection.
It is important that you inform your pediatrician or other healthcare provider of your use of Humira during pregnancy, before the child receives any type of vaccination (for more information on vaccinations, see “Warnings and precautions”).

Driving and using machines
Humira may affect, albeit only to a modest extent, your ability to drive, ride a bicycle or use machinery. Following the administration of Humira, you may experience visual disturbances and a sensation that the environment around you is rotating. Humira contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml of dose, i.e. essentially ‘sodium-free’.

3. Come usare Humira

Usi questo medicinale seguendo sempre esattamente le istruzioni del medico o del farmacista. Se ha
dubbi consulti il medico o il farmacista. Il medico potrebbe prescrivere un’altra concentrazione di
Humira se necessita di una dose differente.
Adulti con artrite reumatoide, artrite psoriasica, spondilite anchilosante o spondiloartrite assiale senza
evidenza radiografica di spondilite anchilosante
Humira va iniettato sotto la pelle (uso sottocutaneo). La dose abituale per gli adulti con artrite
reumatoide, spondilite anchilosante, spondiloartrite assiale senza evidenza radiografica di spondilite
anchilosante e per pazienti con artrite psoriasica è di 40 mg di adalimumab a settimane alterne,
somministrato in un’unica dose.
Nell’artrite reumatoide, il metotressato viene continuato durante il trattamento con Humira. Se il medico
decide che il metotressato non è appropriato, Humira può essere somministrato da solo.
Se è affetto da artrite reumatoide e non riceve metotressato in associazione al trattamento con Humira,
il medico può decidere di prescriverle 40 mg di adalimumab ogni settimana o 80 mg a settimane alterne.
Bambini, adolescenti e adulti con artrite idiopatica giovanile poliarticolare

Bambini e adolescenti a partire da 2 anni di età e con peso compreso tra 10 kg e meno di 30 kg
La dose raccomandata di Humira è 20 mg a settimane alterne.

Bambini, adolescenti e adulti a partire da 2 anni di età e con peso uguale o superiore a 30 kg
La dose raccomandata di Humira è 40 mg a settimane alterne.
Bambini, adolescenti e adulti con artrite associata ad entesite

Bambini eadolescenti a partire da 6 anni di età e con peso compreso tra 15 kg e meno di 30 kg
La dose raccomandata di Humira è 20 mg a settimane alterne.

Bambini, adolescenti e adulti a partire da 6 anni di età e con peso uguale o superiore a 30 kg
La dose raccomandata di Humira è 40 mg a settimane alterne.
Adulti con psoriasi
La dose abituale di Humira per gli adulti con psoriasi è una dose iniziale di 80 mg (tramite due iniezioni
da 40 mg in un giorno), seguita da una dose di 40 mg, somministrata a settimane alterne, ad iniziare
dalla settimana successiva all’assunzione della dose iniziale. Deve continuare il trattamento con Humira
per il tempo indicato dal medico. In funzione alla risposta clinica, il medico può aumentare il dosaggio
a 40 mg ogni settimana o 80 mg a settimane alterne.
Bambini e adolescenti con psoriasi a placche

Bambini e adolescenti di età compresa tra 4 e 17 anni e con peso uguale o superiore a 30 kg
La dose raccomandata di Humira è una dose iniziale di 40 mg, seguita da una dose di 40 mg la
settimana seguente. Successivamente, la dose abituale è di 40 mg a settimane alterne.
Adulti con idrosadenite suppurativa
La dose abituale per l’Idrosadenite Suppurativa è una dose iniziale di 160 mg (tramite quattro iniezioni
da 40 mg in un giorno o due iniezioni da 40 mg al giorno per due giorni consecutivi), seguita da una
dose di 80 mg (tramite due iniezioni da 40 mg in un giorno) due settimane dopo. Dopo altre due
settimane, continuare con una dose di 40 mg a settimana o 80 mg a settimane alterne, come prescritto
dal medico. Si raccomanda di utilizzare tutti i giorni una soluzione di lavaggio antisettica sulle aree
interessate.
Adolescenti con idrosadenite suppurativa di età compresa tra 12 e 17 anni d’età, con peso uguale o
superiore a 30 kg
La dose raccomandata di Humira è una dose iniziale di 80 mg (tramite due iniezioni da 40 mg in un
giorno), seguita da 40 mg somministrati a settimane alterne a partire da una settimana dopo la dose
iniziale. In caso di risposta inadeguata a 40 mg di Humira a settimane alterne, il medico può aumentare
il dosaggio a 40 mg ogni settimana o 80 mg a settimane alterne.
Si raccomanda di utilizzare tutti i giorni una soluzione di lavaggio antisettica sulle aree interessate.
Adulti con malattia di Crohn
La dose abituale in caso di malattia di Crohn è inizialmente di 80 mg (tramite due iniezioni da 40 mg in
un giorno) seguita da 40 mg a settimane alterne, dopo due settimane. Nel caso sia necessaria una risposta
più rapida, il medico può prescrivere una dose iniziale di 160 mg (tramite quattro iniezioni da 40 mg in
un giorno o due iniezioni da 40 mg al giorno per due giorni consecutivi) seguita da 80 mg (tramite due
iniezioni da 40 mg in un giorno) dopo due settimane , e successivamente 40 mg a settimane alterne. In
funzione della risposta clinica, il medico può aumentare il dosaggio a 40 mg ogni settimana o 80 mg a
settimane alterne.
Bambini e adolescenti con malattia di Crohn

Bambini e adolescenti di età compresa tra 6 e 17 anni e con peso inferiore a 40 kg
La dose abituale è inizialmente di 40 mg seguita da 20 mg dopo due settimane. Se è necessario indurre
una risposta più rapida, il medico può prescrivere una dose iniziale di 80 mg (tramite due iniezioni da
40 mg in un giorno) seguita da 40 mg dopo due settimane.
Successivamente, la dose abituale è di 20 mg a settimane alterne. In funzione della risposta clinica, il
medico può aumentare la frequenza della dose a 20 mg ogni settimana.

Bambini ed adolescenti di età compresa tra 6 e 17 anni e con peso uguale o superiore a 40 kg
La dose abituale è inizialmente di 80 mg (tramite due iniezioni da 40 mg in un giorno) seguita da 40 mg
dopo due settimane. Se è necessario indurre una risposta più rapida, il medico può prescrivere una dose
iniziale di 160 mg (tramite quattro iniezioni da 40 mg in un giorno o due iniezioni da 40 mg al giorno
per due giorni consecutivi) seguita da 80 mg (tramite due iniezioni da 40 mg in un giorno) dopo due
settimane.
Successivamente, la dose abituale è di 40 mg a settimane alterne. In funzione della risposta clinica, il
medico può aumentare il dosaggio a 40 mg ogni settimana o 80 mg a settimane alterne.
Adulti con colite ulcerosa
La dose abituale di Humira per gli adulti con colite ulcerosa è di 160 mg (tramite quattro iniezioni da
40 mg in un giorno o due iniezioni da 40 mg al giorno per due giorni consecutivi) alla settimana 0 e di
80 mg (tramite due iniezioni da 40 mg in un giorno) alla settimana 2 e successivamente di 40 mg a
settimane alterne. In funzione della risposta clinica, il medico può aumentare il dosaggio a 40 mg ogni
settimana o 80 mg a settimane alterne.
Bambini e adolescenti con colite ulcerosa

Bambini e adolescenti a partire dai 6 anni di età e con peso inferiore a 40 kg
La dose abituale di Humira è di 80 mg (tramite due iniezioni da 40 mg in un giorno), seguita da 40 mg
(tramite una sola iniezione da 40 mg) due settimane dopo. Successivamente, la dose abituale è di
40 mg a settimane alterne.
I pazienti che compiono 18 anni mentre assumono 40 mg a settimane alterne devono continuare la
dose prescritta.

Bambini e adolescenti a partire dai 6 anni di età e con peso uguale o superiore a 40 kg
La dose abituale di Humira è di 160 mg (tramite quattro iniezioni da 40 mg in un giorno o due
iniezioni da 40 mg al giorno per due giorni consecutivi) seguita da 80 mg (tramite due iniezioni da
40 mg in un giorno) dopo due settimane. Successivamente la dose abituale è di 80 mg a settimane
alterne.
I pazienti che compiono 18 anni mentre assumono 80 mg a settimane alterne devono continuare la
dose prescritta.
Adulti con uveite non infettiva
La dose abituale per gli adulti con uveite non infettiva è una dose iniziale di 80 mg (tramite due iniezioni
in un giorno), seguita da 40 mg somministrati a settimane alterne a partire da una settimana dopo la dose
iniziale. Deve continuare a iniettarsi il trattamento con Humira per tutto il tempo indicato dal medico.
Nell’uveite non infettiva, i corticosteroidi o gli altri farmaci che influiscono sul sistema immunitario
potranno essere continuati durante il trattamento con Humira. Humira può essere somministrato in
monoterapia.
Bambini e adolescenti con uveite cronica non infettiva a partire da 2 anni di età

Bambini e adolescenti a partire da 2 anni di età e con peso inferiore a 30 kg
La dose abituale di Humira è di 20 mg somministrati a settimane alterne con metotressato.
Il medico potrebbe prescrivere anche una dose iniziale da 40 mg che può essere somministrata una
settimana prima dell’inizio della dose abituale.

Bambini e adolescenti a partire da 2 anni di età e con peso uguale o superiore a 30 kg
La dose abituale di Humira è di 40 mg somministrati a settimane alterne con metotressato.
Il medico potrebbe prescrivere anche una dose iniziale da 80 mg che può essere somministrata una
settimana prima dell’inizio della dose abituale.

Modo e via di somministrazione
Humira è somministrato per iniezione sotto la cute (per iniezione sottocutanea).

Istruzioni per la preparazione e l’iniezione di Humira
Le seguenti istruzioni spiegano come iniettare Humira. Legga attentamente le istruzioni e le segua passo
dopo passo. Riceverà istruzioni dal medico o dal suo assistente sulla tecnica dell’auto-somministrazione.
Non proceda all’iniezione da solo finché non è sicuro di aver capito come preparare ed eseguire la
somministrazione. Dopo adeguate istruzioni l’iniezione può essere eseguita da lei o da altre persone
quali, ad esempio, un familiare o un amico.
Il contenuto della siringa non deve essere mescolato ad altri farmaci nella stessa siringa o nel flaconcino.

1)Preparazione

Si lavi accuratamente le mani.
Sistemi i seguenti oggetti su una superficie pulita

o Una siringa pre-riempita di Humira iniettabile
o Un tampone imbevuto di alcool

Syringe pre-filled with needle protected by cap, flanked by a sterile swab and container on a gray tray

Controlli la data di scadenza sulla siringa. Non usi il prodotto oltre il mese e l’anno indicati.

2)Scelta e preparazione di un sito d’iniezione

Scelga un punto sulla coscia o sulla pancia.

Stylized human torso with gray areas indicating possible subcutaneous injection sites in the upper arms and in the abdomen

Ogni nuova iniezione deve essere somministrata ad almeno 3 cm dal sito dell’ultima iniezione. o Non esegua l’iniezione in zone in cui la pelle appare arrossata, siano presenti ematomi o risulti indurita. Ciò potrebbe indicare la presenza di un’infezione. o Strofini la sede di iniezione con il tampone imbevuto di alcool, con un movimento circolare. o Non tocchi nuovamente la zona prima dell’iniezione.

3)Iniezione di Humira

NON agiti la siringa.
Rimuova il tappo dall’ago della siringa, facendo attenzione a non toccare l’ago o che l’ago non tocchi nessuna superficie.
Con una mano, prenda delicatamente la zona già strofinata con l’alcool e la mantenga ferma.

Hand holding a syringe tilted at 45 degrees while injecting the drug into the arm of a patient with the other hand

Con l’altra mano, impugni la siringa (con la parte scanalata rivolta verso l’alto) formando un angolo di 45° rispetto al punto di iniezione.
Con un movimento deciso e rapido, spinga tutto l’ago nella pelle.
Lasci la pelle con la prima mano.
Spinga lo stantuffo per iniettare la soluzione - possono occorrere dai 2 ai 5 secondi per svuotare la siringa.
Quando la siringa è vuota, rimuova l’ago dalla pelle, mantenendo la stessa angolazione di quando è stato inserito.
Con il pollice o un pezzo di garza, eserciti una pressione sulla sede di iniezione per 10 secondi. Si potrebbe verificare un piccolo sanguinamento. Non massaggi la sede di iniezione. Se lo desidera, applichi un cerotto.

4)Smaltimento dei materiali

Non riutilizzi MAIla siringa di Humira. Non reincappucci MAIl’ago.
Dopo aver iniettato Humira, getti via immediatamente la siringa usata in un contenitore speciale secondo le istruzioni del medico, infermiere o farmacista.
Tenga il contenitore fuori dalla vista e dalla portatadei bambini.

Instructions for preparing and injecting Humira
The following instructions explain how to inject Humira. Read the instructions carefully and follow them
step by step. You will receive instructions from your doctor or their assistant on the technique
of self-administration. Do not proceed with self-injection until you are sure you have understood how to
prepare and perform the administration. After adequate instructions, the injection can be performed by
you or another person, such as a family member or friend.
The contents of the syringe must not be mixed with other medicines in the same syringe.

1)Preparation

Wash your hands thoroughly
Arrange the following items on a clean surface
o A pre-filled syringe of Humira injectable solution
o An alcohol-soaked swab

Prefilled syringe with visible plunger next to a cotton swab on a rectangular tray

Check the expiry date on the syringe. Do not use the product beyond the month and year indicated.

2) Choosing and preparing an injection site

Choose a spot on the thigh or abdomen

Lower part of the human body with gray areas indicating intramuscular injection sites in the buttocks

Each new injection must be administered at least 3 cm from the site of the last injection.
o Do not inject into areas where the skin is reddened, bruised or
hardened. This could indicate the presence of an infection.
o Rub the injection site with the alcohol-soaked swab, with a circular
motion.
o Do not touch the area again before the injection.

3)Injecting Humira

DO NOT shake the syringe.
Remove the cap from the syringe needle, being careful not to touch the needle or let the needle touch any surface.
With one hand, gently grasp the area already rubbed with alcohol and hold it steady

Hand holding a syringe with needle inserted into the skin of the arm, subcutaneous injection technique illustrated with simple lines

With the other hand, hold the syringe with the ribbed part facing upwards, forming a 45° angle to the injection point.
With a firm and rapid movement, push the entire needle into the skin
Release the skin with your first hand
Push the plunger to inject the solution - it may take 2 to 5 seconds to empty the syringe
When the syringe is empty, remove the needle from the skin, maintaining the same angle as when it was inserted
Hold the syringe in one hand and with the other slide the protective sheath over the exposed needle until it stops in position.
With your thumb or a piece of gauze, apply pressure to the injection site for 10 seconds. A small amount of bleeding may occur. Do not massage the injection site. If desired, apply a bandage.

4)Disposal of materials

NEVER reuse the Humira syringe. NEVER recap the needle
After injecting Humira, immediately dispose of the used syringe in a special container according to the instructions of your doctor, nurse or pharmacist. Keep this medicine out of the sight and reach of children.

If you use more Humira than you should
If you accidentally inject Humira more frequently than prescribed by your doctor or pharmacist,
contact your doctor or pharmacist informing them that you have taken more medicine. Always keep the
medicine box, even if it is empty.

If you forget to use Humira
If you forget to give an injection, you should inject the next dose of Humira as soon as you remember.
Then resume the dose regularly according to the established dosage schedule.

If you stop using Humira
The decision to stop using Humira should be discussed with your doctor. Symptoms may
return after discontinuation.
If you have any doubts about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate in severity. However, some may be serious and require treatment. Side effects may occur
up to 4 months after the last injection of Humira.
Tell your doctor immediately if you notice any of the following reactions

severe skin rash, hives or other signs of an allergic reaction;
swelling of the face, hands, feet;
difficulty breathing, difficulty swallowing;
shortness of breath on exertion or when lying down, or swollen feet.

Tell your doctor as soon as possible if you notice any of the following reactions

signs of infection such as fever, feeling unwell, sores, dental problems, burning when urinating;
fatigue or weakness;
cough;
tingling;
numbness;
double vision;
weakness of the arms or legs;
swelling or a sore that does not heal;
signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, paleness.

The symptoms described above may be signs of the following side effects, which have been observed
with Humira.
Very common (may affect more than 1 in 10 people)

reactions at the injection site (including pain, swelling, redness or itching);
respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
headache;
abdominal pain;
nausea and vomiting;
skin rash;
musculoskeletal pain.

Common (may affect up to 1 in 10 people)

serious infections (including sepsis and influenza);
intestinal infections (including gastroenteritis);
skin infections (including cellulitis and herpes zoster infection);
ear infections;
oral infections (including dental infections and herpes simplex);
reproductive system infections;
urinary tract infections;
fungal infections;
infections affecting the joints;
benign tumors;
skin cancer;
allergic reactions (including seasonal allergies);
dehydration;
mood changes (including depression);
anxiety;
sleep disorders;
sensory disturbances such as tingling, pricking or numbness;
migraine;
nerve root compression (including lower back pain and leg pain);
visual disturbances;
eye inflammation;
inflammation of the eyelids and swelling of the eyes;
dizziness;
feeling of a racing heartbeat;
high blood pressure;
hot flashes;
bruising;
cough;
asthma;
shortness of breath;
gastrointestinal bleeding;
dyspepsia (indigestion, bloating, heartburn);
acid reflux;
dry eye syndrome (including dry eyes and mouth);
itching;
itchy skin rash;
contusion;
skin inflammation (such as eczema);
nail breakage of the fingers and toes;
increased sweating;
hair loss;
onset or worsening of psoriasis;
muscle spasms;
blood in urine;
kidney problems;
chest pain;
edema;
fever;
decreased platelets in the blood, which increases the risk of bleeding or bruising;
difficulty healing wounds.

Uncommon (may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when the immune defenses are reduced);
neurological infections (including viral meningitis);
eye infections;
bacterial infections;
diverticulitis (inflammation and infection of the large intestine);
tumors;
tumors of the lymphatic system;
melanoma;
immune system disorders that can affect the lungs, skin and lymph nodes (which most commonly present as sarcoidosis);
vasculitis (inflammation of blood vessels);
tremor;
neuropathy;
stroke;
hearing loss, ringing in the ears;
feeling of irregular heartbeat such as palpitations;
heart problems that can cause shortness of breath or swelling at the ankles;
acute myocardial infarction;
formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
lung disease causing shortness of breath (including inflammation);
pulmonary embolism (blockage of a pulmonary artery);
pleural effusion (abnormal collection of fluid in the pleural space);
inflammation of the pancreas causing severe pain in the abdomen and back;
difficulty swallowing;
facial edema;
inflammation of the gallbladder, gallstones;
fatty liver;
night sweats;
scarring;
abnormal muscle breakdown;
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs);
interrupted sleep;
impotence;
inflammations.

Rare (may affect up to 1 in 1,000 people)

leukemia (a cancer that affects the blood and bone marrow);
severe allergic reaction with shock;
multiple sclerosis;
neurological disorders (such as optic nerve inflammation and Guillain-Barré syndrome, which can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
cardiac arrest;
pulmonary fibrosis (scarring of the lungs);
intestinal perforation;
hepatitis;
reactivation of hepatitis B;
autoimmune hepatitis (inflammation of the liver caused by your own immune system);
cutaneous vasculitis (inflammation of the blood vessels in the skin);
Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash);
facial edema associated with allergic reactions;
erythema multiforme (inflammatory skin rash);
lupus-like syndrome;
angioedema (localized swelling of the skin);
lichenoid skin reaction (itchy, reddish-purple skin rash).

Not known (frequency cannot be estimated based on available data)

T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal);
Merkel cell carcinoma (a type of skin cancer);
Kaposi's sarcoma, a rare cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
liver failure;
worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
Weight gain (weight gain has been low for most patients)

Some of the side effects observed with Humira may be asymptomatic and can only be
detected through blood tests. These include:
Very common (may affect more than 1 in 10 people)

low white blood cell count;
low red blood cell count;
increased lipids in the blood;
increased liver enzymes.

Common (may affect up to 1 in 10 people)

increased white blood cell count;
decreased platelet count;
increased uric acid in the blood;
alteration of sodium in the blood;
decreased calcium in the blood;
decreased phosphorus in the blood;
increased sugar in the blood;
increased lactate dehydrogenase in the blood;
presence of autoantibodies in the blood;
decreased potassium in the blood.

Uncommon (may affect up to 1 in 100 people)

high levels of bilirubin in the blood (liver blood test).

Rare (may affect up to 1 in 1,000 people)

low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Humira

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2  C – 8  C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single ready-to-use syringe can be
stored at room temperature (up to 25°C) for a maximum period of 14 days – make sure to
protect the medicine from light. Once it has been removed from the refrigerator to be stored at
room temperature, the syringe must be used within 14 days or discarded, even if it is placed
back in the refrigerator.
You must record the date on which the syringe is removed from the refrigerator for the first time and the date after which
the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor or pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humira contains
The active substance is adalimumab.
The excipients are mannitol, citric acid monohydrate, sodium citrate, sodium phosphate monobasic
dihydrate, sodium phosphate dibasic dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for
injections.

Description of the appearance of Humira pre-filled syringe and contents of the pack
Humira 40 mg solution for injection in pre-filled syringes is supplied as a sterile solution of 40 mg of
adalimumab dissolved in 0.8 ml of solution.
Humira pre-filled syringe consists of a solution of adalimumab contained in a glass syringe.
Each pack contains 1, 2, 4 or 6 pre-filled syringes with 1, 2, 4 or 6 alcohol swabs respectively.
Not all pack sizes may be marketed.
Humira may be available in vial, pre-filled syringe and/or pre-filled pen.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/ .

large> or

Humira 40 mg solution for injection in pre-filled pen

adalimumab

Read this leaflet carefully before you start to use this medicine because it contains important
information for you

Keep this leaflet. You may need to read it again.
Your doctor will give you a Patient Reminder Card, which contains important safety information, that you need to know before administering Humira and during treatment with Humira. Keep this Patient Reminder Card.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, because it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Humira is and what it is used for
2. What you need to know before you use Humira
3. How to use Humira
4. Possible side effects
5. How to store Humira
6. Contents of the pack and other information

1. What is Humira and what is it used for

Humira contains the active ingredient adalimumab.
Humira is indicated for the treatment of the inflammatory diseases listed below:

Rheumatoid arthritis,
Polyarticular juvenile idiopathic arthritis,
Arthritis associated with enthesitis,
Ankylosing spondylitis,
Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
Psoriatic arthritis,
Psoriasis,
Hidradenitis suppurativa,
Crohn's disease,
Ulcerative colitis and
Non-infectious uveitis

The active ingredient contained in Humira, adalimumab, is a human monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target.
The target of adalimumab is a protein called tumor necrosis factor (TNFα), which is
involved in the immune system (defense) and is present at higher concentrations in the inflammatory
diseases listed above. By binding to TNFα, Humira decreases the inflammatory process
of these diseases.
Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Humira is used to treat rheumatoid arthritis in adults.
If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs, such as methotrexate, may be initially administered. If the response to these drugs is not satisfactory,
you will be given Humira to treat rheumatoid arthritis.
Humira can also be used to treat severe, active and progressive rheumatoid arthritis
without previous treatment with methotrexate.
Humira has been shown to be able to slow the progression of cartilage and bone damage in
the joints caused by the disease, and to improve physical function.
Generally Humira is used with methotrexate. If your doctor decides that treatment with
methotrexate is not appropriate, Humira can be administered alone.
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis are inflammatory diseases.
Humira is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged
2 to 17 years and arthritis associated with enthesitis in children and adolescents aged 6-17 years.
Other disease-modifying drugs, such as methotrexate, may be administered at diagnosis.
If the response to these drugs is not adequate, you will be given Humira for the
treatment of polyarticular juvenile idiopathic arthritis or arthritis associated with enthesitis.
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis are inflammations of the spine.
Humira is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic
evidence of ankylosing spondylitis in adults. If you have ankylosing spondylitis or axial
spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first take other
medications. If you are unable to achieve an adequate response with these medications, you will take
Humira to reduce the signs and symptoms of the disease.
Psoriatic arthritis
Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
Humira is used to treat psoriatic arthritis in adults.
Humira has been shown to be able to slow the damage to cartilage and bone in the joints,
caused by the disease, and to improve physical function.
Plaque psoriasis in adults and children
Plaque psoriasis is a skin condition that causes red, scaly, and hardened patches of
skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to
break, thicken, and lift from the nail bed, which can be painful. Psoriasis is believed to be caused by a problem with the body's immune system that leads to increased
skin cell production.
Humira is used to treat moderate to severe plaque psoriasis in adults. Humira is
also used to treat severe plaque psoriasis in children and adolescents from 4 to 17 years of age
in whom topical therapy and phototherapies have not worked optimally or are not indicated.
Hidradenitis Suppurativa in adults and adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a chronic inflammatory disease of
the skin and is often painful. Symptoms may include painful nodules and abscesses (cysts) that can
drain pus. It most frequently affects specific areas of the skin, such as the submammary region,
the armpits, the inner thighs, the groin, and the buttocks. Scars can also form in the affected areas.
Humira is used to treat Hidradenitis Suppurativa in adults and adolescents from 12 years of
age. Humira can reduce the number of nodules and abscesses you have and the pain that is often associated with
this disease. Initially, you may receive other medications. If you do not respond well enough
to these medications, you will receive Humira.
Crohn's disease in adults and children
Crohn's disease is an inflammation of the digestive tract.
Humira is used to treat Crohn's disease in adults and children aged 6 to 17 years. If
you suffer from Crohn's disease, you will first be given other medications. If you do not
respond adequately to these medications, you will be given Humira to
reduce the typical symptoms of Crohn's disease.
Ulcerative colitis in adults and children
Ulcerative colitis is an inflammation of the large intestine.
Humira is used to treat moderate to severe ulcerative colitis in adults and children aged 6
to 17 years. If you have ulcerative colitis, you may initially take other medications. If you
are unable to achieve an adequate response with these medications, you will take Humira to reduce
the signs and symptoms of the disease.
Non-infectious uveitis in adults and children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Humira is used for the treatment of:

Adults with non-infectious uveitis with inflammation affecting the back of the eye
Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

2. What you need to know before using Humira

Do not use Humira

If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
If you have a severe infection, including active tuberculosis (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, such as e.g. fever, wounds, feeling tired, dental problems.
If you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Humira

If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not administer Humira again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.
If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Humira. If you have doubts, contact your doctor.
You may be more likely to get infections during treatment with Humira. This risk may increase if your lung function is impaired. These infections can be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis which, in rare cases, can be life-threatening. It is important to tell your doctor if you have symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise temporarily stopping Humira.
Because cases of tuberculosis have occurred in patients treated with Humira, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Humira. This will involve collecting a detailed medical assessment including your medical history and appropriate clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis may develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.
Tell your doctor if you live in or travel to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are endemic.
Tell your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.
Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis virus

B. Your doctor should test you for hepatitis B virus infection. Taking Humira may cause reactivation of the hepatitis B virus in subjects who are carriers of this virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of the hepatitis B virus can be life-threatening.

If you are over 65 years of age, you may be more susceptible to infections while taking Humira. You and your doctor should pay particular attention to signs of infection while you are being treated with Humira. It is important to tell your doctor if symptoms of infections such as fever, wounds, feeling tired or dental problems appear.
Before surgery or dental procedures, tell your doctor that you are taking Humira. Your doctor may advise temporarily stopping it.
If you have or develop demyelinating diseases such as multiple sclerosis, your doctor will decide whether to start or continue treatment with Humira. Tell your doctor

immediately if you experience symptoms such as changes in vision, weakness of
arms or legs or numbness or tingling that affects any part of the body.

Certain vaccines can cause infections and should not be given during treatment with Humira. Consult your doctor before getting vaccinated. In children, it is advisable, if possible, to implement the vaccination schedule provided for, in compliance with current vaccination guidelines, before starting therapy with Humira. If you have taken Humira during pregnancy, the child may have a higher risk of contracting this infection up to approximately 5 months after the last dose you took during pregnancy. It is important that you inform your pediatrician or other healthcare provider of your use of Humira during pregnancy, so that they can decide when the child should receive any type of vaccination.
If you have mild heart failure and are being treated with Humira at the same time, your doctor will need to carefully assess and monitor your heart condition. It is important to tell your doctor about any heart problems, both past and present. If new symptoms of heart failure appear or existing symptoms worsen (for example, shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide whether Humira can be used.
In some patients, the body may not be able to produce enough blood cells to help fight infections or stop bleeding. If you have persistent fever, bruising or easy bleeding or paleness, see your doctor immediately. The latter may decide to stop the therapy.
In patients, both children and adults, undergoing treatment with Humira or with other anti-TNF drugs, very rare cases of certain types of tumors have occurred. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukemia (a cancer affecting the blood and bone marrow). If you take Humira, the risk of developing lymphomas, leukemia or other tumors may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients undergoing therapy with Humira. Some of these patients were also being treated with azathioprine or 6-mercaptopurine. Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira. In addition, cases of non-melanoma skin cancer have been observed in patients taking Humira. If new skin lesions appear during or after therapy or if the appearance of existing lesions changes, report it to your doctor.
There have been cases of neoplasms, in addition to lymphoma, in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another anti-TNF. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNF is appropriate.
Rarely, treatment with Humira can lead to the manifestation of a syndrome like lupus. Tell your doctor if you experience symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

Vaccinations: if possible, children should have had all vaccinations before using Humira.
Do not give Humira to children with juvenile idiopathic polyarticular arthritis under the age of 2 years.

Other medicines and Humira
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Humira can be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), steroids or
analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).

Humira must not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of serious infections. If you have doubts, ask your doctor.

Pregnancy and breastfeeding

You should consider using adequate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Humira.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice on taking this medicine.
Humira should only be used during pregnancy if necessary.
According to a pregnancy study, no increased risk of birth defects was found when the mother had received Humira during pregnancy, compared to mothers with the same condition who had not received Humira.
Humira can be used during breastfeeding.
If you take Humira during pregnancy, the child may have a higher risk of contracting an infection.
It is important that you inform your pediatrician or other healthcare provider of your use of Humira during pregnancy, before the child receives any type of vaccination. For more information on vaccinations, see “Warnings and precautions”.

Driving and using machines
Humira may affect, albeit only to a modest extent, your ability to drive, ride a bicycle
or use machines. After taking Humira, you may experience visual disturbances and a
sensation that the environment around you is rotating.

Humira contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially
‘sodium-free’.

3. How to use Humira

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, ask your doctor or pharmacist. Your doctor may prescribe a different concentration of
Humira if you need a different dose.
Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondylarthritis without
radiographic evidence of ankylosing spondylitis
Humira should be injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid
arthritis, ankylosing spondylitis, axial spondylarthritis without radiographic evidence of ankylosing
spondylitis and for patients with psoriatic arthritis is 40 mg of adalimumab every other week,
administered as a single dose.
In rheumatoid arthritis, methotrexate is continued during treatment with Humira. If your doctor
decides that methotrexate is not appropriate, Humira can be administered alone.
If you have rheumatoid arthritis and are not receiving methotrexate in combination with treatment with Humira,
your doctor may decide to prescribe 40 mg of adalimumab every week or 80 mg every other week.
Children, adolescents and adults with polyarticular juvenile idiopathic arthritis

Children and adolescents starting from 2 years of age and weighing between 10 kg and less than 30 kg
The recommended dose of Humira is 20 mg every other week.

Children, adolescents and adults starting from 2 years of age and weighing 30 kg or more
The recommended dose of Humira is 40 mg every other week.
Children, adolescents and adults with arthritis associated with enthesitis

Children and adolescents starting from 6 years of age and weighing between 15 kg and less than 30 kg
The recommended dose of Humira is 20 mg every other week.

Children, adolescents and adults starting from 6 years of age and weighing 30 kg or more
The recommended dose of Humira is 40 mg every other week.
Adults with psoriasis
The usual dose of Humira for adults with psoriasis is an initial dose of 80 mg (via two 40 mg injections
on one day), followed by a dose of 40 mg, administered every other week, starting
the week after the initial dose. You must continue treatment with Humira
for the time indicated by your doctor. Depending on the clinical response, your doctor may increase the dosage
to 40 mg every week or 80 mg every other week.
Children and adolescents with plaque psoriasis

Children and adolescents between 4 and 17 years of age and weighing between 15 kg and less than 30 kg
The recommended dose of Humira is an initial dose of 20 mg, followed by a dose of 20 mg the
following week. Subsequently, the usual dose is 20 mg every other week.

Children and adolescents between 4 and 17 years of age and weighing 30 kg or more
The recommended dose of Humira is an initial dose of 40 mg, followed by a dose of 40 mg the
following week. Subsequently, the usual dose is 40 mg every other week.
Adults with hidradenitis suppurativa
The usual dose in case of Hidradenitis Suppurativa is an initial dose of 160 mg (via four
40 mg injections on one day or two 40 mg injections per day for two consecutive days), followed
by a dose of 80 mg (via two 40 mg injections on one day) two weeks later. After another
two weeks, continue with a dose of 40 mg per week or 80 mg every other week, as
prescribed by your doctor. It is recommended to use an antiseptic cleansing solution daily
on the affected areas.
Adolescents with hidradenitis suppurativa aged between 12 and 17 years, weighing 30 kg or more
The recommended dose of Humira is an initial dose of 80 mg (via two 40 mg injections on one
day), followed by 40 mg administered every other week starting one week after the initial dose.
In case of inadequate response to 40 mg of Humira every other week, the doctor may increase
the dosage to 40 mg every week or 80 mg every other week.
It is recommended to use an antiseptic cleansing solution daily on the affected areas.
Adults with Crohn's disease
The usual dose in case of Crohn's disease is initially 80 mg (via two 40 mg injections in
one day) followed by 40 mg every other week, after two weeks. If a faster response is needed, the doctor may prescribe an initial dose of 160 mg (via four 40 mg injections in
one day or two 40 mg injections per day for two consecutive days) followed by 80 mg (via two
40 mg injections on one day) after two weeks and subsequently 40 mg every other week. In
depending on the clinical response, the doctor may increase the dosage to 40 mg every week or 80 mg to
every other week.
Children and adolescents with Crohn's disease

Children and adolescents between 6 and 17 years of age and weighing less than 40 kg
The usual dose is initially 40 mg followed by 20 mg after two weeks. If it is necessary to induce
a faster response, the doctor may prescribe an initial dose of 80 mg (via two 40 mg injections in
one day) followed by 40 mg after two weeks.
Subsequently, the usual dose is 20 mg every other week. Depending on the clinical response, the
doctor may increase the frequency of the dose to 20 mg every week.

Children and adolescents between 6 and 17 years of age and weighing 40 kg or more
The usual dose is initially 80 mg (via two 40 mg injections in one day) followed by 40 mg
after two weeks. If a faster response is needed, the doctor may prescribe a dose
initial of 160 mg (via four 40 mg injections in one day or two 40 mg injections per day
for 2 consecutive days) followed by 80 mg (via two 40 mg injections in one day) after two
weeks.
Subsequently, the usual dose is 40 mg every other week. Depending on the clinical response, the
doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Adults with ulcerative colitis
The usual dose of Humira for adults with ulcerative colitis is 160 mg (via four 40 mg injections in
one day or two 40 mg injections per day for two consecutive days) at week 0 and 80 mg (via two 40 mg injections in one day) at week 2 and subsequently 40 mg at
every other week. Depending on the clinical response, the doctor may increase the dosage to 40 mg every
week or 80 mg every other week.
Children and adolescents with ulcerative colitis

Children and adolescents starting from 6 years of age and weighing less than 40 kg
The usual dose of Humira is 80 mg (via two 40 mg injections in one day) followed by 40 mg
(via a single 40 mg injection) after two weeks. Subsequently, the usual dose is
40 mg every other week.
Patients who turn 18 years old while taking 40 mg every other week should continue the
prescribed dose.

Children and adolescents starting from 6 years of age and weighing 40 kg or more
The usual dose of Humira is 160 mg (via four 40 mg injections in one day or two
40 mg injections per day for two consecutive days) followed by 80 mg (via two 40 mg injections in
one day) after two weeks. Subsequently the usual dose is 80 mg every other week.
Patients who turn 18 years old while taking 80 mg every other week should continue the
prescribed dose.
Adults with non-infectious uveitis
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (via two injections
on one day), followed by 40 mg administered every other week starting one week after the initial dose.
You must continue to inject the treatment with Humira for as long as indicated by your doctor.
In non-infectious uveitis, corticosteroids or other drugs that affect the immune system
may be continued during treatment with Humira. Humira can be administered in
monotherapy.
Children and adolescents with chronic non-infectious uveitis starting from 2 years of age

Children and adolescents starting from 2 years of age and weighing less than 30 kg
The usual dose of Humira is 20 mg administered every other week with methotrexate.
The doctor may also prescribe an initial dose of 40 mg which may be administered one
week before the start of the usual dose.

Children and adolescents starting from 2 years of age and weighing 30 kg or more
The usual dose of Humira is 40 mg administered every other week with methotrexate.
The doctor may also prescribe an initial dose of 80 mg which may be administered one
week before the start of the usual dose.

How and route of administration
Humira is administered by injection under the skin (subcutaneous injection).

How to perform the Humira injection yourself
The following instructions explain how to perform a self-injection of Humira using the pre-filled pen.
Read the instructions carefully and follow them step by step. You will receive instructions from your doctor
or assistant on the self-administration technique. Do not proceed with the injection yourself until
you are sure you understand how to prepare and administer the administration. After adequate instructions
the injection can be performed by you or other people such as, for example, a family member or friend.

What is the procedure to follow before self-administering a Humira subcutaneous injection?

1. Wash your hands thoroughly.
2. Remove the single-dose container containing the Humira pre-filled pen from the refrigerator.
3. Do not shake or drop the pre-filled pen.
4. Arrange the following items on a clean surface.

a Humira pre-filled pen
an alcohol swab.

Injectable pen with numbers 1 and 2 indicated and cotton swab next to it

Swab
Window

5. Check the expiration date printed on the label of the pre-filled pen (Exp.). Do not use the product if the date (of self-injection) has exceeded the month and year of expiration indicated.
6. Hold the pre-filled pen with the gray cap (marked with the number '1') facing up. Check the Humira solution through the window on the sides of the pre-filled pen to verify its appearance. The solution should appear clear and colorless. If it appears cloudy or has changed color, impurities or suspended particles are visible in it, the solution should not be used. Do not use a pre-filled pen that has been frozen or exposed to direct sunlight. Remove both the gray and purple caps only immediatelybefore injection.

Medical device with gray U-shaped body and two black shading on a light gray background

Window
Clear liquid in the syringe

In which part of the body should the injection be performed?

1. Choose as an administration site an area located in the upper thigh or stomach (except for the area around the navel).

Scheme of the human body with area highlighted in gray in the lower abdominal region and legs

2. Change the injection site each time so as to avoid a zone becoming painful. Each injection must be made at a distance of at least 3 centimeters from the last chosen injection site.

3. Do not inject in an area where the skin appears reddened, there are bruises, or it feels hardened. The appearance of these signs may indicate that an infection is in progress.

How should the injection be performed?

1. Clean the skin thoroughly using the alcohol swab provided in the package, rubbing it in a circular motion. Avoid touching the area again before performing the injection.
2. Remove both the gray and purple caps only immediatelybefore injection. Hold the gray body of the pre-filled pen with one hand. Position your hand in the middle of the pen so that neither the gray cap (1) nor the purple cap (2) are covered. Hold the pre-filled pen with the gray cap (1) facing up. With the other hand, pull the gray cap (1) outwards, verify that the black protection covering the needle of the syringe has been removed together with the cap, then remove it. If a few small drops of liquid come out of the needle, it is normal. In this way the white sheath covering the needle will be exposed. Do not try to touch the needle inserted into the syringe cylinder. DO NOT REPLACE THE CAPas this could damage the needle inside.

Prefilled syringe with plunger retracted and black arrows indicating the direction of push and release

3. Remove the purple safety cap (marked with the number '2') to expose the purple activation button. The pre-filled pen is now ready for use. Do not press the purple activation button until the syringe has been correctly positioned as this could cause the drug to leak. DO NOT REPLACE THE CAPas this could cause the drug to leak from the pen.

How to inject the medication

1. With your free hand, gently grasp a firm portion of skin chosen as the injection site and already sterilised, and hold it firmly (see the figure below).
2. Position the white end of the pre-filled pen at a right angle (90 degrees) to the skin, in such a way as to be able to see the window present on the pen. The presence of one or more bubbles in the window is normal.
3. While holding the cylinder of the pre-filled pen with your hand, apply light pressure against the injection site (keeping the pen firmly in position without moving it).
4. With your index finger or thumb, press the purple-coloured button located on the upper end of the pen when you are ready to administer the injection (see the figure below). At this point, as the needle is released, you will feel a strong ‘click’ and perceive a slight prick as the needle penetrates the skin.
5. Continue to hold down the button and leave the pre-filled pen in position applying constant pressure for approximately 10 seconds to be certain that the injection has been completed.Do not remove the pre-filled pen while injecting the solution.

Hand holding a self-administered injection device with indication of a 90-degree angle and enlarged detail of the mechanism

Hand holding an injection pen with needle inserted into the skin at 90 degrees and enlargement of the dosage mechanism

6. During the injection you will see a yellow indicator move inside the window (located on the sides of the pen). The injection is complete when the yellow indicator no longer moves. The yellow indicator is part of the plunger of the pre-filled syringe. If the yellow indicator does not appear inside the window, the plunger has not been pushed adequately, and the injection is not complete.
7. Remove the pre-filled pen from the injection site. The white sheath protecting the needle will move onto the needle and lock onto the tip of the needle, covering it. Do not attempt to touch the needle. The white sheath is designed to protect you from contact with the needle.

Prefilled pen with visible needle and arrow indicating the injection point with an area highlighted by a dashed circle

Diagram of an injector with a black needle partially inserted and two horizontal lines indicating the depth

White sheath
for protection
of the needle Window
Yellow indicator
visible
¿

8. You may notice a small drop of blood at the injection site. If so, apply light pressure to the injection site for 10 seconds with a cotton ball or gauze. Do not rub the injection site. If you wish, you can apply a bandage.

How to dispose of the pen

Use each pre-filled pen for only one injection. Do not replace any of the caps on the pre-filled pen.
After injecting Humira, immediately dispose of the used pre-filled pen in a special container according to the instructions of your doctor, nurse or pharmacist.
Keep this container out of the sight and reach of children.

If you use more Humira than you should
If you accidentally inject Humira more frequently than prescribed by your doctor or pharmacist,
contact your doctor or pharmacist informing them that you have taken more medication. Always keep the box
of the medication or the pre-filled pen, even if empty.

If you forget to use Humira
If you forget to administer an injection, you should inject the next dose of Humira as soon as you remember. Afterwards, resume the dose regularly according to the established dosage schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate. However, some can be serious and require treatment. Side effects may occur
up to 4 months after the last injection of Humira.
Tell your doctor immediately if you notice any of the following reactions

severe skin rash, hives or other signs of an allergic reaction;
swelling of the face, hands, feet;
difficulty breathing, difficulty swallowing;
shortness of breath on exertion or when lying down, or swollen feet.

Tell your doctor as soon as possible if you notice any of the following reactions

signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating;
fatigue or weakness;
cough;
tingling;
numbness;
double vision;
weakness of the arms or legs;
swelling or open sore that does not heal;
signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, paleness.

The symptoms described above may be signs of the following side effects, which have been observed
with Humira
Very common (may affect more than 1 in 10 people)

reactions at the injection site (including pain, swelling, redness or itching);
respiratory tract infections (including cold, runny nose, sinusitis and pneumonia);
headache;
abdominal pain;
nausea and vomiting;
skin rash;
musculoskeletal pain.

Common (may affect up to 1 in 10 people)

serious infections (including sepsis and influenza);
intestinal infections (including gastroenteritis);
skin infections (including cellulitis and herpes zoster infection);
ear infections;
oral infections (including dental infections and herpes simplex);
reproductive system infections;
urinary tract infections;
fungal infections;
infections affecting the joints;
benign tumors;
skin cancer;
allergic reactions (including seasonal allergies);
dehydration;
mood changes (including depression);
anxiety;
sleep disorders;
sensory disturbances such as tingling, pricking sensations or numbness;
migraine;
nerve root compression (including lower back pain and leg pain);
visual disturbances;
eye inflammation;
eyelid inflammation and eye swelling;
dizziness;
feeling of a fast heartbeat;
high blood pressure;
hot flashes;
bruising;
cough;
asthma;
shortness of breath;
gastrointestinal bleeding;
dyspepsia (indigestion, bloating, heartburn);
acid reflux;
dry eye syndrome (including dry eyes and mouth);
itching;
itchy skin rash;
contusion;
skin inflammation (such as eczema);
nail breakage of the fingers and toes;
increased sweating;
hair loss;
onset or worsening of psoriasis;
muscle spasms;
blood in the urine;
kidney problems;
chest pain;
edema;
fever;
decreased platelets in the blood, which increases the risk of bleeding or bruising;
difficulty healing.

Uncommon (may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when immune defenses are reduced);
neurological infections (including viral meningitis);
eye infections;
bacterial infections;
diverticulitis (inflammation and infection of the large intestine);
tumors;
tumors of the lymphatic system;
melanoma;
immune system disorders that can affect the lungs, skin and lymph nodes (which most commonly present as sarcoidosis);
vasculitis (inflammation of blood vessels);
tremor;
neuropathy;
stroke;
hearing loss, ringing in the ears;
feeling of irregular heartbeat such as palpitations;
heart problems that can cause shortness of breath or swelling in the ankles;
acute myocardial infarction;
formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
lung disease causing shortness of breath (including inflammation);
pulmonary embolism (blockage of a pulmonary artery);
pleural effusion (abnormal collection of fluid in the pleural space);
inflammation of the pancreas causing severe abdominal and back pain;
difficulty swallowing;
facial swelling;
inflammation of the gallbladder, gallstones;
fatty liver;
night sweats;
scarring;
abnormal muscle breakdown;
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs);
interrupted sleep;
impotence;
inflammations.

Rare (may affect up to 1 in 1,000)

leukemia (a cancer that affects the blood and bone marrow);
severe allergic reaction with shock;
multiple sclerosis;
neurological disorders (such as optic nerve inflammation and Guillain-Barré syndrome, which can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
cardiac arrest;
pulmonary fibrosis (scarring of the lungs);
intestinal perforation;
hepatitis;
reactivation of hepatitis B;
autoimmune hepatitis (inflammation of the liver caused by your own immune system);
cutaneous vasculitis (inflammation of the blood vessels in the skin);
Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash);
facial swelling associated with allergic reactions;
lichenoid skin reaction (itchy, red-purple rash);
lupus-like syndrome;
angioedema (localized swelling of the skin).

Not known (frequency cannot be estimated based on available data)

T-cell hepato-splenic lymphoma (a rare blood cancer that is often fatal);
Merkel cell carcinoma (a type of skin cancer);
Kaposi's sarcoma, a rare cancer associated with human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin;
liver failure;
worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness);
Weight gain (weight gain has been low for most patients)

Some of the side effects observed with Humira may be asymptomatic and can only be
detected through blood tests. These include:
Very common (may affect more than 1 in 10 people)

low white blood cell count;
low red blood cell count;
increased lipids in the blood;
increased liver enzymes.

Common (may affect up to 1 in 10 people)

increased white blood cell count;
decreased platelet count;
increased uric acid in the blood;
alteration of sodium in the blood;
decreased calcium in the blood;
decreased phosphorus in the blood;
increased sugar in the blood;
increased lactate dehydrogenase in the blood;
presence of autoantibodies in the blood;
decreased potassium in the blood.

Uncommon (may affect up to 1 in 100 people)

high levels of bilirubin in the blood (liver blood test).

Rare (may affect up to 1 in 1,000)

low white blood cell count, red blood cell count and platelet count.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Humira

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2  C – 8  C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled pen can be stored
at room temperature (up to 25°C) for a maximum period of 14 days – ensure that the
medicine is protected from light. Once it is removed from the refrigerator to be stored at room
temperature, the pen must be used within 14 days or discarded, even if it is placed back in the
refrigerator.
You must record the date on which the pen is removed from the refrigerator for the first time and the date after which the
pen must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor or pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humira contains
The active ingredient is adalimumab.
The excipients are mannitol, citric acid monohydrate, sodium citrate, sodium phosphate monobasic
dihydrate, sodium phosphate dibasic dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for
injections.

Description of the appearance of Humira pre-filled pen and contents of the pack
Humira 40 mg solution for injection in pre-filled pens is supplied as a sterile solution of 40 mg of
adalimumab dissolved in 0.8 ml of solution.
The Humira pre-filled pen is a single-use pen, coloured grey and purple, containing a glass syringe
in which Humira is present. The pen is equipped with two caps – one grey marked with the
number ‘1’ and the other purple marked with the number ‘2’. On each side of the pen there is
a window through which the Humira solution inside the
syringe can be glimpsed.
The Humira pre-filled pen is available in packs containing 1, 2, 4 and 6 pre-filled pens.
The 1 pen pre-filled pack contains 2 alcohol swabs (1 spare). The 2, 4 and 6 pen pre-filled packs are supplied with 1 alcohol swab for each pre-
filled pen.
Not all pack sizes may be marketed.
Humira may be available in vial, pre-filled syringe and/or pre-filled pen.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
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Humira 40 mg injectable solution in pre-filled syringe

adalimumab

Read this leaflet carefully before using this medicine as it contains important
information for you

Keep this leaflet. You may need to read it again.
Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before administering Humira and during treatment with Humira. Keep this Patient Reminder Card.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Humira is and what it is used for
2. What you need to know before you use Humira
3. How to use Humira
4. Possible side effects
5. How to store Humira
6. Contents of the pack and other information
7. Injecting Humira

1. What is Humira and what is it used for

Humira contains the active ingredient adalimumab.
Humira is used for the treatment of

Rheumatoid arthritis
Polyarticular juvenile idiopathic arthritis
Arthritis associated with enthesitis
Ankylosing spondylitis
Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Psoriatic arthritis
Plaque psoriasis
Hidradenitis suppurativa
Crohn’s disease
Ulcerative colitis
Non-infectious uveitis

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
Humira is used to treat moderate to severe rheumatoid arthritis in adults.
Initially, other disease-modifying drugs, such as methotrexate, may be taken. If the
response to such drugs is not satisfactory, you will be given Humira.
Humira can also be used for the treatment of severe, active and
progressive rheumatoid arthritis without prior treatment with methotrexate.

Humira may slow down the progression of joint damage caused by the disease

inflammatory and may help you move more freely.
The doctor will decide whether Humira should be taken with methotrexate or alone.

Juvenile idiopathic polyarticular arthritis
Juvenile idiopathic polyarticular arthritis is an inflammatory disease of the joints.
Humira is used to treat juvenile idiopathic polyarticular arthritis in patients aged 2 years or
older. Other disease-modifying drugs, such as methotrexate, may initially be taken. If the response to these drugs is inadequate, you will be given Humira.
The doctor will decide whether Humira should be taken with methotrexate or alone.

Enthesitis-related arthritis
Enthesitis-related arthritis is an inflammatory disease of the joints and areas where
tendons attach to bones.
Humira is used to treat enthesitis-related arthritis in patients aged 6 years or older.
Other disease-modifying drugs, such as methotrexate, may initially be taken. If
the response to these drugs is inadequate, you will be given Humira.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis are inflammations of the spine.
Humira is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic
evidence of ankylosing spondylitis of severe grade in adults. Other drugs may initially be
taken. If the response to these drugs is inadequate, you will be given
Humira.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints usually associated with
psoriasis.
Humira is used to treat psoriatic arthritis in adults. Humira may slow down the damage to the
joints caused by the disease and may help you move more freely. Other drugs may initially
be taken. If the response to these drugs is inadequate, you will be given
Humira.

Plaque psoriasis
Plaque psoriasis is a skin condition that causes red, scaly, and hardened patches
of skin covered with silvery scales. Plaque psoriasis can also affect the nails,
causing them to break, thicken, and lift from the nail bed, which can be
painful.
Humira is used to treat

chronic moderate-to-severe plaque psoriasis in adults and
chronic severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical therapy and phototherapies have not worked well enough or are not indicated.

Hidradenitis Suppurativa
Hidradenitis Suppurativa (sometimes called inverse acne) is a chronic inflammatory
skin disease and is often painful. Symptoms may include painful nodules and abscesses (cysts) that
may drain pus. It most frequently affects specific areas of the skin, such as the
submammary region, armpits, inner thighs, groin, and buttocks. Scars can also form
in the affected areas.
Humira is used to treat

moderate-to-severe hidradenitis suppurativa in adults and
moderate-to-severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Humira may reduce the number of nodules and abscesses caused by the disease. Other drugs may initially
be taken. If the response to these drugs is inadequate, you will be given
Humira.

Crohn’s Disease
Crohn’s disease is an inflammation of the digestive tract.
Humira is used to treat

moderate-to-severe Crohn’s disease in adults and
moderate-to-severe Crohn’s disease in children and adolescents aged 6 to 17 years.

Other drugs may initially be taken. If the response to these drugs is inadequate, you will be given
Humira.

Ulcerative colitis
Ulcerative colitis is an inflammation of the large intestine.
Humira is used to treat

moderate-to-severe ulcerative colitis in adults and
moderate-to-severe ulcerative colitis in children and adolescents aged 6 to 17 years.

Other drugs may initially be taken. If the response to these drugs is inadequate, you will be given
Humira.

Non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Humira is used for the treatment of:

adults with non-infectious uveitis with inflammation affecting the back of the eye
children aged 2 years and older with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation can lead to a decrease in vision and/or the presence of floaters
in the eye (small dark spots or thin lines that move across the field of vision). Humira works
by reducing this inflammation.
Other drugs may initially be taken. If the response to these drugs is inadequate, you will be given
Humira.

2. What you need to know before using Humira

Do not use Humira

If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
If you have active tuberculosis or other serious infections (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, for example, fever, wounds, feeling tired, dental problems.
If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Humira.
Allergic reactions

If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, stop taking Humira and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

If you have an infection, including long-term infections or infections located in one part of the body (for example, leg ulcers), consult your doctor before starting treatment with Humira. If you have any doubts, contact your doctor.
You may be more likely to get infections during treatment with Humira. This risk may increase if you have lung problems. These infections can be serious and include:
tuberculosis
infections caused by viruses, fungi, parasites or bacteria
severe blood infections (sepsis)

In rare cases, these infections can be life-threatening. It is important to
tell your doctor if you have symptoms such as fever, wounds, feeling tired or
dental problems. Your doctor may tell you to stop Humira for a period of time.

Tell your doctor if you live or travel to regions where fungal infections are very common (e.g. histoplasmosis, coccidioidomycosis or blastomycosis).
Tell your doctor if you have had infections that keep recurring or if you have other conditions that increase the risk of infection.
If you are over 65 years of age, you may be more likely to get infections while taking Humira. You and your doctor should pay particular attention to signs of infection during treatment with Humira. It is important to tell your doctor if you develop symptoms of infections such as fever, wounds, feeling tired or dental problems.

Tuberculosis

It is very important to tell your doctor if you have ever had tuberculosis, or if you have been in contact with someone who has had tuberculosis. You should not take Humira if you have active tuberculosis.
Because cases of tuberculosis have occurred in patients treated with Humira, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Humira. This will involve collecting a detailed medical assessment including your medical history and appropriate clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card.
Tuberculosis can develop during therapy even if you have received treatment to prevent tuberculosis.
Contact your doctor immediately if symptoms of tuberculosis (e.g. cough that does not go away, weight loss, lack of energy, mild fever) or other infections appear during or after therapy.

Hepatitis B

Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis B virus.
Your doctor should test you for hepatitis B virus infection. In HBV carriers, taking Humira may cause the virus to reactivate.
In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of the hepatitis B virus can be life-threatening.

Surgery or dental procedures

Before surgery or dental procedures, tell your doctor that you are taking Humira. Your doctor may advise you to temporarily stop Humira.

Demyelinating diseases

If you have or develop a demyelinating disease (a disease that affects the insulating layer around nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Humira. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccinations

Certain vaccines can cause infections and should not be given during treatment with Humira.
Consult your doctor before getting vaccinated.
It is recommended, if possible, to give children all the vaccinations recommended for their age before starting treatment with Humira.
If you have taken Humira during pregnancy, the baby may be at increased risk of contracting an infection up to about 5 months after the last dose of Humira given. It is important that you tell your pediatrician or other healthcare provider about your use of Humira during pregnancy, so they can decide when the baby should receive any type of vaccination.

Heart failure

If you have mild heart failure and are receiving concomitant treatment with Humira, your doctor will need to carefully evaluate and monitor your heart condition. It is important to tell your doctor about any heart problems, past or present. If new symptoms of heart failure or worsening of existing symptoms (e.g. shortness of breath or swelling of the feet) appear, contact your doctor immediately. The doctor will decide if Humira can be used.

Fever, bruising, bleeding or paleness

In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. Your doctor may decide to stop therapy. If you have persistent fever, bruising or easy bleeding, or paleness, see your doctor immediately.

Tumors

In patients, both children and adults, undergoing treatment with Humira or other anti-TNF drugs, some types of tumors have occurred very rarely.
Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow).
If you are taking Humira, the risk of developing lymphomas, leukemia or other tumors may increase. In rare circumstances, a rare and serious type of lymphoma has been observed in patients treated with Humira. Some of these patients were also being treated with azathioprine or 6-mercaptopurine.
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
Cases of non-melanoma skin cancer have been observed in patients taking Humira.
If new skin lesions appear during or after therapy or if the appearance of existing lesions changes, tell your doctor.
Cases of neoplasms, in addition to lymphoma, have been observed in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another anti-TNF. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNF is appropriate.

Autoimmune disease

Rarely, treatment with Humira can lead to the development of a syndrome like lupus. Tell your doctor if you develop symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

Vaccinations: if possible, children should have all the vaccinations before using Humira.

Other medicines and Humira
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not use Humira with medicines that contain the following active ingredients due to the increased risk
of having serious infections:

anakinra
abatacept

Humira can be used with:

methotrexate
other disease-modifying antirheumatic drugs (e.g. sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts)
steroids or pain relievers, including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have any doubts, ask your doctor.

Pregnancy and breastfeeding

You should consider using appropriate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Humira.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice on taking this medicine.
Humira should only be used during pregnancy if necessary.
According to a pregnancy study, no increased risk of birth defects was found when the mother received Humira during pregnancy, compared to mothers who had the same condition but did not receive Humira.
Humira can be used during breastfeeding.
If you take Humira during pregnancy, the baby may be at increased risk of contracting an infection.
It is important that you tell your pediatrician or other healthcare provider about your use of Humira during pregnancy, before the baby receives any type of vaccination. For further information on vaccinations, see “Warnings and precautions”.

Driving and using machines
Humira may have a small marginal effect on your ability to drive, ride a bicycle or
use machines. After taking Humira, you may experience vision disturbances and the
sensation that the environment around you is spinning.

3. How to use Humira

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
doubts, consult your doctor or pharmacist.
The recommended doses of Humira in each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Humira if you need a different
dose.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Age or body weight	How much should be taken and how often?	or Notes
Adults	40 mg every other week l	c In rheumatoid arthritis, continue to take the a methotrexate during treatment with Humira. If the m doctor decides that methotrexate is not appropriate, Humira can be administered alone. r a If you have rheumatoid arthritis and are not taking F methotrexate in combination with Humira, your doctor may decide to prescribe 40 mg of Humira every week or 80 mg every other week.

e Juvenile idiopathic polyarticular arthritis
Age or body weight	d How much should be taken and how often?	Notes
Children, adolescents and adults a from 2 years of age and with weight equal to or greater than 30 kg	40 mg every other week a	Not applicable
Children and adolescents from 2 years of age and weighing between 10 kg and less than 30 kg	n 20 mg every other week a	Not applicable

i Arthritis associated with enthesitis
Age or body weight	l a How much should be taken and how often?	Notes
Children, adolescents and adults a from 6 years of age and with weight equal to or greater than 30 kg	t 40 mg every other week I	Not applicable
Children and adolescents from a 6 years of age and weighing between 15 kg and less than 30 kg	20 mg every other week	Not applicable

z Plaque psoriasis
n Age or body weight	How much should be taken and how often?	Notes
e Adults g A	An initial dose of 80 mg (two injections of 40 mg in one day) followed by a dose of 40 mg, administered every other week, starting the week following taking the initial dose.	In case of inadequate response, the doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Children and adolescents aged between 4 and 17 years and with weight equal to or greater than 30 kg	An initial dose of 40 mg, followed by 40 mg after one week. Subsequently, the usual dose is 40 mg every other week.	Not applicable o c a
Children and adolescents aged between 4 and 17 years and with weight between 15 kg and less than 30 kg	An initial dose of 20 mg, followed by 20 mg after one week. Subsequently, the usual dose is 20 mg every other week.	m Not applicable r a

F Hidradenitis suppurativa
Age or body weight	How much should be taken and how often?	Note
Adults	l e An initial dose of 160 mg (four 40 mg injections in d one day or two 40 mg injections for two consecutive days), followed by a dose of 80 mg (two a 40 mg injections on the same day) two weeks later. After another two weeks, continue with a dose of 40 mg per week or 80 mg every other week, as prescribed by the doctor.	It is recommended to use an antiseptic cleansing solution on the affected areas every day.
Adolescents aged between 12 and 17 years, weighing equal to or greater than 30 kg a	i An initial dose of 80 mg l (two 40 mg injections in one a day), followed by 40 mg every other week, starting t one week after the initial dose.	In case of inadequate response to 40 mg of Humira every other week, the doctor may increase the dosage to 40 mg every week or 80 mg every other week. It is recommended to use an antiseptic cleansing solution on the affected areas every day.

Crohn’s disease
Age or body weight	How much should be taken and how often?	Note
Children, adolescents and adults a from 6 years of age with weight equal to or greater than 40 kg	An initial dose of 80 mg (two 40 mg injections in one day) followed by 40 mg after two weeks. If a faster response is needed, the doctor may prescribe an initial dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) after two weeks. l Subsequently, the usual dose is 40 mg every other week.	o The doctor may increase the dosage to 40 mg every week or 80 mg every other week. c a m r a F
Children and adolescents aged between 6 and 17 years and with weight less than 40 kg	d An initial dose of 40 mg followed by 20 mg after two weeks. a If a faster response is needed, the doctor may prescribe an initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg after two weeks. a Subsequently, the usual dose is 20 mg every other week.	The doctor may increase the frequency of the dose to 20 mg every week.

I Ulcerative colitis
Age or body weight	How much should be taken and how often?	Note
a Adults i z n e g	An initial dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) after two weeks. Subsequently, the usual dose is 40 mg every other week.	The doctor may increase the dosage to 40 mg every week or 80 mg every other week.
A Children and adolescents from 6 years of age and weighing less than 40 kg	An initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg (one 40 mg injection) after two weeks.	Humira should be continued at the usual dose, even after turning 18 years of age.

	Subsequently, the usual dose is 40 mg every other week.
Children and adolescents from 6 years of age and weighing equal to or greater than 40 kg	An initial dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) after two weeks. Subsequently, the usual dose is 80 mg every other week.	o Humira should be continued at the usual dose, even after turning 18 years of age. c a m r

Non-infectious uveitis
Age or body weight	How much should be taken and how often?	F Note
Adults	l An initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week, starting e one week after the initial dose.	Corticosteroids or other drugs that affect the immune system may be continued during treatment with Humira. Humira can be administered as monotherapy.
Children and adolescents from 2 years of age and weighing less than 30 kg	a 20 mg every other week n a i	The doctor may prescribe an initial dose of 40 mg to be administered one week before starting the usual dose of 20 mg every other week. The use of Humira is recommended in combination with methotrexate.
Children and adolescents from 2 years of age and weighing at least 30 kg a	l a 40 mg every other week t I	The doctor may prescribe an initial dose of 80 mg to be administered one week before starting the usual dose of 40 mg every other week. The use of Humira is recommended in combination with methotrexate.

How to administer and route of administration
Humira is administered by injection under the skin (subcutaneous injection).

Detailed instructions on how to administer Humira are described in section 7 ‘Humira injection’.
If you use more Humira than you should
If you accidentally inject Humira more frequently than prescribed by your doctor or pharmacist,
contact your doctor or pharmacist informing them that you have taken more medicine. Always keep the box
of the medicine, even if empty.

If you forget to use Humira
If you forget to make an injection, you should inject the next dose of Humira as soon as you remember.
Then resume the dose regularly according to the prescribed dosage schedule.

If you stop taking Humira
The decision to stop using Humira should be discussed with your doctor. Symptoms may
return if you stop using Humira.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate in severity. However, some can be serious and require treatment. Side effects may occur
up to 4 months after the last injection of Humira.

Immediately inform your doctor if you notice any of the following reactions

severe rash, hives or other signs of an allergic reaction
swelling of the face, hands, feet
difficulty breathing, difficulty swallowing
shortness of breath on exertion or when lying down or swollen feet

Inform your doctor as soon as possible if you notice any of the following reactions

signs of infection such as fever, feeling unwell, sores, dental problems, burning when urinating
fatigue or weakness
cough
tingling
numbness
double vision
weakness of the arms or legs
sore or open wound that does not heal
signs and symptoms suggesting the development of blood system disorders, such as persistent fever, bruising, bleeding, paleness

The symptoms described above may be signs of the following side effects, which have been observed
with Humira

Very common(may affect more than 1 in 10 people)

reactions at the injection site (including pain, swelling, redness or itching)
respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia)
headache
abdominal pain
nausea and vomiting
rash
musculoskeletal pain

Common(may affect up to 1 in 10 people)

serious infections (including sepsis and influenza)
intestinal infections (including gastroenteritis)
skin infections (including cellulitis and herpes zoster infection)
ear infections
oral infections (including dental infections and herpes simplex)
reproductive system infections
urinary tract infections
fungal infections
joint infections
benign tumors
skin cancer
allergic reactions (including seasonal allergies)
dehydration
mood changes (including depression)
anxiety
sleep disorders
sensory disturbances such as tingling, pricking or numbness
migraine
nerve root compression (including lower back pain and leg pain)
visual disturbances
eye inflammation
eyelid inflammation and eye swelling
dizziness (feeling of spinning or whirling)
feeling of a fast heartbeat
high blood pressure
hot flashes
bruise (blood accumulation outside of blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heartburn)
acid reflux
dry eye syndrome (including dry eyes and dry mouth)
itching
itchy rash
contusion
skin inflammation (such as eczema)
nail breakage of the fingers and toes
increased sweating
hair loss
onset or worsening of psoriasis
muscle spasms
blood in the urine
kidney problems
chest pain
edema (fluid retention)
fever
decreased platelets in the blood, which increases the risk of bleeding or bruising
difficulty healing wounds

Uncommon(may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when immune defenses are reduced)
neurological infections (including viral meningitis)
eye infections
bacterial infections
diverticulitis (inflammation and infection of the large intestine)
tumors
tumors of the lymphatic system
melanoma
immune system disorders that can affect the lungs, skin and lymph nodes (which most commonly present as sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (nervous system disorders)
stroke
hearing loss, ringing in the ears
irregular heartbeat such as palpitations
heart problems that can cause shortness of breath or swelling at the ankles
acute myocardial infarction (heart attack)
formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel
lung disease that causes shortness of breath (including inflammation)
pulmonary embolism (blockage of a pulmonary artery)
pleural effusion (abnormal accumulation of fluid in the pleural space)
inflammation of the pancreas causing severe pain in the abdomen and back
difficulty swallowing
facial edema (swelling of the face)
inflammation of the gallbladder, gallstones
fatty liver
night sweats
scarring
abnormal muscle breakdown
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs)
interrupted sleep
impotence
inflammations

Rare(may affect up to 1 in 1,000 people)

leukemia (a cancer that affects the blood and bone marrow)
severe allergic reaction with shock
multiple sclerosis
neurological disorders (such as optic nerve inflammation and Guillain-Barré syndrome, which can cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
cardiac arrest
pulmonary fibrosis (scarring of the lungs)
intestinal perforation (hole in the intestine)
hepatitis
reactivation of hepatitis B
autoimmune hepatitis (inflammation of the liver caused by your own immune system);
cutaneous vasculitis (inflammation of the blood vessels in the skin)
Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash)
facial edema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome
angioedema (localized swelling of the skin)
lichenoid skin reaction (itchy, reddish-purple rash)

Not known(frequency cannot be estimated from available data)

T-cell hepatic-splenic lymphoma (a rare blood cancer that is often fatal)
Merkel cell carcinoma (a type of skin cancer)
Kaposi's sarcoma, a rare cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness)
Weight gain (weight gain has been small for most patients)

Some of the side effects observed with Humira may be asymptomatic and can only be
identified through blood tests.
These include:

Very common(may affect more than 1 in 10 people)

low white blood cell count
low red blood cell count
increased lipids in the blood
increased liver enzymes

Common(may affect up to 1 in 10 people):

increased white blood cell count
decreased platelet count
increased uric acid in the blood
alteration of sodium in the blood
decreased calcium in the blood
decreased phosphorus in the blood
increased sugar in the blood
increased lactate dehydrogenase in the blood
presence of autoantibodies in the blood
decreased potassium in the blood

Uncommon(may affect up to 1 in 100 people)

high levels of bilirubin in the blood (liver blood test).

Rare(may affect up to 1 in 1,000 people):

low white blood cell, red blood cell and platelet counts.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Humira

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2  C – 8  C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled syringe can be stored
at room temperature (up to 25°C) for a maximum period of 14 days – ensure that the
medicine is protected from light. Once it has been removed from the refrigerator to be stored at room
temperature, the syringe must be used within 14 days or discarded, even if it is placed back in the
refrigerator.
You must record the date on which the syringe is removed from the refrigerator for the first time and the date after which
the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor or pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humira contains
The active substance is adalimumab.
The excipients are mannitol, polysorbate 80 and water for injections.

Description of the appearance of Humira pre-filled syringe and contents of the pack
Humira 40 mg solution for injection in pre-filled syringes is supplied as a sterile solution of 40 mg of
adalimumab dissolved in 0.4 ml of solution.
Humira pre-filled syringe consists of a solution of adalimumab contained in a glass syringe.
Each pack contains 1, 2, 4 or 6 pre-filled syringes with 1, 2, 4 or 6 alcohol swabs respectively.
Not all pack sizes may be marketed.
Humira may be available in a vial, in a pre-filled syringe and/or in a pre-filled pen.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/ .

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holder.

7. Humira Injection

The following instructions explain how to perform a subcutaneous self-injection of Humira using the pre-filled syringe. First, read the instructions carefully and follow them step by step.
You will receive instructions from your doctor, nurse, or pharmacist on the self-administration technique.
Do not proceed with the injection on your own until you are sure you understand how to prepare and perform the injection.
After adequate instruction, the injection can be performed by you or by other people, such as a family member or friend.
Use each pre-filled syringe exclusively for a single injection.

Humira pre-filled syringe
PlungerFinger gripNeedle cap

Prefilled syringe with gray butterfly plunger and transparent cylinder with medicinal liquid inside

Do not use the pre-filled syringe and contact your doctor or pharmacist if

the solution appears cloudy, has changed color, or contains flocculi and particles
the expiration date (Exp.) has been exceeded
the solution has been frozen or exposed to direct sunlight
the pre-filled syringe has been dropped or damaged

Only remove the needle cap immediately before the injection. Keep Humira out of the
sight and reach of children.
STEP 1
Remove Humira from the refrigerator.
Before performing the injection, allow Humira to reach room temperature for 15-30 minutes.

Do notremove the needle cap while waiting for Humira to reach room temperature
Do notheat Humira in other ways. For example, do notheat in the microwave or in hot water. STEP 2

Syringe
Check the expiration date (Exp.). Do notuse the pre-
filled syringe if the expiration date (Exp.) has been exceeded.
Arrange the following items on a clean, flat surface

Prefilled syringe in blister packaging with removable protection and detail of a hand removing it

1 single-use pre-filled syringe
1 alcohol swab

Wash and dry your hands.
~'
~

~~~
~

Swab
STEP 3
Injection areas
Choose an injection site:

On the front of the thigh or
On the abdomen (stomach) at least 5 cm from the navel
At least 3 cm from the last injection site

Rub the injection site with circular motions,
using the alcohol swab.

Person with medical patches applied to abdomen and knees, enlarged detail of a hand applying a patch

Do notinject through clothing
Do notinject into areas where the skin appears red or hardened, there are bruises, ulcers, scars, stretch marks, or areas with plaque psoriasis

Injection areas
STEP 4Hold the pre-filled syringe with one hand.
Check the liquid in the pre-filled syringe.

Make sure the liquid is clear and colorless
Do notuse the pre-filled syringe if the liquid is cloudy or contains particles
Do notuse the pre-filled syringe if it has been dropped or crushed

Remove the cap from the syringe needle gently with
your other hand. Dispose of the cap. Do not reuse the cap.

Do nottouch the needle with your fingers, and make sure the needle does not come into contact with anything STEP 5Hold the pre-filled syringe with the needle pointing upwards.

Hand holding an injection device with transparent needle and a cross-shaped support for it

Hold the pre-filled syringe at eye level with one hand, so you can see the air in the pre-filled syringe

Slowly push the plunger to expel the air through
the needle.

It is normal to see a drop of liquid at the end of the needle

STEP 6Hold the pre-filled syringe with one hand between your thumb and
index finger, like a pencil.
With your other hand, grasp the skin at the injection site to lift it and hold it firmly

Hand holding a self-injector with exposed needle and enlarged detail of the injection point in the skin

STEP 7Insert the needle completely into the skin with
an angle of approximately 45° with a quick and
decisive movement.

When the needle is inserted, release the skin.

Push the plunger completely until all the
liquid has been injected and the pre-filled syringe is empty.

Subcutaneous injection with a syringe at a 45-degree angle in the arm, detail of the needle penetrating the skin and angle indicated with a triangle

STEP 8When the syringe is empty, slowly remove the needle from
the skin, maintaining the same angle as when it was
inserted.
After performing the injection, press a cotton ball or
gauze pad on the skin at the injection site.

Subcutaneous injection with a syringe: one hand stabilizes the skin while the

Do notrub
It is normal for slight bleeding to occur at the injection site

Cotton ball
STEP 9
Dispose of the used pre-filled syringe in a special container, according to the instructions of your doctor,
nurse, or pharmacist. Never recap the needle.

Do notrecycle or dispose of the pre-filled syringe in household waste
Always keep the pre-filled syringe and the special waste container out of the sight and reach of children.

The needle cap, alcohol swab, cotton ball or gauze, blister, and
packaging can be disposed of in household waste.

Humira 40 mg solution for injection in pre-filled pen

adalimumab

Read this leaflet carefully before you start using this medicine as it contains important
information for you

Keep this leaflet. You may need to read it again.
Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before you start using Humira and during treatment with Humira. Keep this Patient Reminder Card.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Humira is and what it is used for
2. What you need to know before you use Humira
3. How to use Humira
4. Possible side effects
5. How to store Humira
6. Contents of the pack and other information
7. Injecting Humira

1. What is Humira and what is it used for

Humira contains the active ingredient adalimumab.
Humira is used for the treatment of

Rheumatoid arthritis
Polyarticular juvenile idiopathic arthritis
Enthesitis-related arthritis
Ankylosing spondylitis
Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Psoriatic arthritis
Plaque psoriasis
Hidradenitis suppurativa
Crohn’s disease
Ulcerative colitis
Non-infectious uveitis

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory condition of the joints.
Humira is used to treat moderate to severe rheumatoid arthritis in adults.
Initially, other disease-modifying drugs, such as methotrexate, may be taken. If the
response to these drugs is not satisfactory, you will be given Humira.
Humira can also be used to treat severe, active and progressive rheumatoid arthritis
without prior treatment with methotrexate.
Humira may slow the progression of joint damage caused by the inflammatory disease
and may help you move more freely.
The doctor will decide whether Humira should be taken with methotrexate or alone.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.
Humira is used to treat polyarticular juvenile idiopathic arthritis in patients aged 2 years or older. Initially, other disease-modifying drugs, such as methotrexate, may be taken.
If the response to these drugs is not adequate, you will be given Humira.
The doctor will decide whether Humira should be taken with methotrexate or alone.

Enthesitis-related arthritis
Enthesitis-related arthritis is an inflammatory disease of the joints and areas where the
tendons attach to the bones.
Humira is used to treat enthesitis-related arthritis in patients aged 6 years or older.
Initially, other disease-modifying drugs, such as methotrexate, may be taken. If the
response to these drugs is not adequate, you will be given Humira.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis are inflammations of the spine.
Humira is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic
evidence of ankylosing spondylitis in adults. Initially, other drugs may be taken. If the response to these drugs is not adequate, you will be given Humira.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints usually associated with psoriasis.
Humira is used to treat psoriatic arthritis in adults. Humira may slow the damage to the
joints caused by the disease and may help you move more freely. Initially, other drugs may be
taken. If the response to these drugs is not adequate, you will be given Humira.

Plaque psoriasis
Plaque psoriasis is a skin condition that causes red, scaly, and hardened patches of
skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to
break, thicken, and lift from the nail bed, which can be painful.
Humira is used to treat

chronic moderate to severe plaque psoriasis in adults and
chronic severe plaque psoriasis in children and adolescents from 4 to 17 years of age in whom topical therapies and phototherapies have not worked well enough or are not appropriate.

Hidradenitis Suppurativa
Hidradenitis Suppurativa (sometimes called inverse acne) is a chronic inflammatory disease of
the skin and is often painful. Symptoms can include painful nodules and abscesses (cysts) that can
drain pus. It most frequently affects specific areas of the skin, such as the submammary region,
the armpits, the inner thighs, the groin, and the buttocks. Scars can also form in the affected areas.
Humira is used to treat

moderate to severe hidradenitis suppurativa in adults and
moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Humira can reduce the number of nodules and abscesses caused by the disease, and the pain that is often
associated with this disease. Initially, other drugs may be taken. If the response to these
drugs is not adequate, you will be given Humira.

Crohn’s disease
Crohn’s disease is an inflammation of the digestive tract.
Humira is used to treat

moderate to severe Crohn’s disease in adults and
moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

Initially, other drugs may be taken. If the response to these drugs is not adequate, you will be given Humira.

Ulcerative colitis
Ulcerative colitis is an inflammation of the large intestine.
Humira is used to treat

moderate to severe ulcerative colitis in adults and
moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.

Initially, other drugs may be taken. If the response to these drugs is not adequate, you will be given Humira.

Non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Humira is used for the treatment of:

Adults with non-infectious uveitis with inflammation affecting the back of the eye
Children aged 2 years and older with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation can lead to a decrease in vision and/or the presence of floaters
in the eye (small dark spots or thin lines that move across the field of vision). Humira works
by reducing this inflammation. Initially, other drugs may be taken. If the response to
these drugs is not adequate, you will be given Humira.

2. What you need to know before using Humira

Do not use Humira:

if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
if you have active tuberculosis or other serious infections (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, dental problems.
if you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Humira.
Allergic reactions

If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not take Humira again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

If you have an infection, including long-term infections or infections located in one part of the body (for example, leg ulcers), consult your doctor before starting treatment with Humira. If you have doubts, contact your doctor.
You may be more likely to get infections during treatment with Humira. This risk may increase if you have lung problems. These infections can be serious and include:
tuberculosis
infections caused by viruses, fungi, parasites or bacteria
serious blood infections (sepsis)

In rare cases, these infections can be life-threatening. It is important
to tell your doctor if you develop symptoms such as fever, wounds, feeling tired or
dental problems. Your doctor may tell you to stop Humira for a period of time.

Tell your doctor if you live or travel to regions where fungal infections are very common (e.g. histoplasmosis, coccidioidomycosis or blastomycosis).
Tell your doctor if you have had infections that keep recurring or if you have other conditions that increase your risk of infection.
If you are over 65 years of age, you may be more likely to get infections while taking Humira. You and your doctor should pay particular attention to signs of infection during treatment with Humira. It is important to tell your doctor if you develop symptoms of infections such as fever, wounds, feeling tired or dental problems.

Tuberculosis

It is very important to tell your doctor if you have ever had tuberculosis, or if you have been in contact with someone who has had tuberculosis. You should not take Humira if you have active tuberculosis.
Because cases of tuberculosis have occurred in patients treated with Humira, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Humira. This will involve a thorough medical assessment of your medical history and appropriate clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card.
Tuberculosis can develop during therapy even if you have received treatment to prevent tuberculosis.
Contact your doctor immediately if symptoms of tuberculosis (e.g. cough that does not go away, weight loss, lack of energy, mild fever) or other infections appear during or after therapy.

Hepatitis B

Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis B virus.
Your doctor should test you for hepatitis B virus infection. In HBV carriers, taking Humira may cause the virus to reactivate.
In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of the hepatitis B virus can be life-threatening.

Surgery or dental procedures

Before surgery or dental procedures, tell your doctor that you are taking Humira. Your doctor may advise you to temporarily stop Humira.

Demyelinating diseases

If you have or develop a demyelinating disease (a disease that affects the insulating layer around nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Humira. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccinations

Certain vaccines can cause infections and should not be given during treatment with Humira.
Consult your doctor before getting vaccinated.
It is recommended, if possible, to have children receive all vaccinations recommended for their age before starting treatment with Humira.
If you have taken Humira during pregnancy, the baby may be at increased risk of contracting an infection up to about 5 months after the last dose of Humira administered. It is important that you tell your pediatrician or other healthcare provider about your use of Humira during pregnancy so that they can decide when the baby should receive any type of vaccination.

Heart failure

If you have mild heart failure and are being treated with Humira, your heart failure status should be carefully monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new symptoms of heart failure or if existing symptoms worsen (e.g. shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide if you can take Humira.

Fever, bruising, bleeding or paleness

In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. Your doctor may decide to stop therapy. If you have persistent fever, bruising or easy bleeding, or paleness, see your doctor immediately.

Tumors

In patients, children and adults, undergoing treatment with Humira or other anti-TNF drugs, some types of tumors have very rarely occurred.
Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow).
If you take Humira, your risk of developing lymphomas, leukemia or other tumors may increase. In rare circumstances, a rare and serious type of lymphoma has been observed in patients treated with Humira. Some of these patients were also being treated with azathioprine or 6-mercaptopurine.
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
Cases of non-melanoma skin cancer have been observed in patients taking Humira.
If new skin lesions appear during or after therapy or if the appearance of existing lesions changes, tell your doctor.
Cases of neoplasms, in addition to lymphoma, have occurred in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another anti-TNF. If you have COPD, or smoke heavily, you should discuss with your doctor whether treatment with an anti-TNF is appropriate.

Autoimmune disease

Rarely, treatment with Humira can lead to the development of a syndrome like lupus. Tell your doctor if you develop symptoms such as a persistent unexplained rash, fever, joint pain, or fatigue.

Children and adolescents

Vaccinations: if possible, children should have had all vaccinations before using Humira.

anakinra
abatacept

Humira can be taken with:

methotrexate
other disease-modifying antirheumatic drugs (e.g. sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts)
steroids or pain relievers, including nonsteroidal anti-inflammatory drugs (NSAIDs).

If you have doubts, ask your doctor.

Pregnancy and breastfeeding

You should consider using appropriate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Humira.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice about taking this medicine.
Humira should only be used during pregnancy if necessary.
According to a pregnancy study, no increased risk of birth defects was found when the mother received Humira during pregnancy, compared to mothers with the same condition who had not received Humira.
Humira can be used during breastfeeding.
If you take Humira during pregnancy, the baby may be at increased risk of contracting an infection.
It is important that you tell your pediatrician or other healthcare provider about your use of Humira during pregnancy before the baby receives any type of vaccination. For more information on vaccinations, see “Warnings and precautions”.

3. How to use Humira

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Humira in each approved indication are listed in the following
table. Your doctor may prescribe a different concentration of Humira if you need a different
dose.

Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Age or body weight	How much should be taken and how often?	o Notes
Adults	40 mg every other week l	c In rheumatoid arthritis, continue to take a methotrexate during treatment with Humira. If the m doctor decides that methotrexate is not appropriate, Humira can be administered alone. r a If you have rheumatoid arthritis and are not taking F methotrexate in combination with Humira, your doctor may decide to prescribe 40 mg of Humira every week or 80 mg every other week.

e Juvenile idiopathic polyarticular arthritis
Age or body weight	d How much should be taken and how often?	Note
Children, adolescents and adults a from 2 years of age and with weight equal to or greater than 30 kg	40 mg every other week a	Not applicable
Children and adolescents from 2 years of age and weighing between 10 kg and less than 30 kg	n 20 mg every other week a	Not applicable

i Arthritis associated with enthesitis
Age or body weight	l a How much should be taken and how often?	Note
Children, adolescents and adults a from 6 years of age and with weight equal to or greater than 30 kg	t 40 mg every other week I	Not applicable
Children and adolescents from a 6 years of age and weighing between 15 kg and less than 30 kg	20 mg every other week	Not applicable

z Plaque psoriasis
n Age or body weight	How much should be taken and how often?	Note
e Adults g A	An initial dose of 80 mg (two injections of 40 mg in one day) followed by a dose of 40 mg, administered every other week, starting the week following the initial dose.	In case of inadequate response, the doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Children and adolescents aged between 4 and 17 years and weighing equal to or greater than 30 kg	An initial dose of 40 mg, followed by 40 mg after one week. Subsequently, the usual dose is 40 mg every other week.	Not applicable o c a
Children and adolescents aged between 4 and 17 years and weighing between 15 kg and less than 30 kg	An initial dose of 20 mg, followed by 20 mg after one week. Subsequently, the usual dose is 20 mg every other week.	m Not applicable r a

F Hidradenitis suppurativa
Age or body weight	How much should be taken and how often?	Note
Adults	l e An initial dose of 160 mg (four 40 mg injections in d one day or two 40 mg injections per day for two consecutive days), followed by a dose of 80 mg (two 40 mg injections on the same day) two weeks later. After two more weeks, continue with a dose of 40 mg per week or 80 mg every other week, as prescribed by the doctor.	It is recommended to use daily an antiseptic cleansing solution on the affected areas.
Adolescents aged between 12 and 17 years, weighing equal to or greater than 30 kg a	i An initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting from one week after the initial dose.	In case of inadequate response to 40 mg of Humira every other week, the doctor may increase the dosage to 40 mg every week or 80 mg every other week. It is recommended to use daily an antiseptic cleansing solution on the affected areas.

Crohn’s disease
Age or body weight	How much should be taken and how often?	Note
Children, adolescents and adults a from 6 years of age and with weight equal to or greater than 40 kg	An initial dose of 80 mg (two injections of 40 mg in one day) followed by 40 mg after two weeks. If a faster response is needed, the doctor may prescribe an initial dose of 160 mg (four injections of 40 mg in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) after two weeks. l Subsequently, the usual dose is 40 mg every other week.	o The doctor may increase the dosage to 40 mg every week or 80 mg every other week. c a m r a F
Children and adolescents aged between 6 and 17 years and weighing less than 40 kg	d An initial dose of 40 mg followed by 20 mg after two weeks. a If a faster response is needed, the doctor may prescribe an initial dose of 80 mg (two injections of 40 mg in one day), followed by 40 mg after two weeks. a Subsequently, the usual dose is 20 mg every other week.	The doctor may increase the frequency of the dose to 20 mg every week.

I Ulcerative colitis
Age or body weight	How much should be taken and how often?	Note
a Adults i z n e g	An initial dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) after two weeks. Subsequently, the usual dose is 40 mg every other week.	The doctor may increase the dosage to 40 mg every week or 80 mg every other week.
A Children and adolescents from 6 years of age and weighing less than 40 kg	An initial dose of 80 mg (two injections of 40 mg in one day), followed by 40 mg (one injection of 40 mg) after two weeks.	Humira should continue to be taken at the usual dose, even after turning 18 years of age.

	Subsequently, the usual dose is 40 mg every other week.
Children and adolescents from 6 years of age and weighing equal to or greater than 40 kg	An initial dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) after two weeks. Subsequently, the usual dose is 80 mg every other week.	o Humira should continue to be taken at the usual dose, even after turning 18 years of age. c m r

Non-infectious uveitis
Age or body weight	How much should be taken and how often?	F Note
Adults	l An initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting from one week after the initial dose.	Corticosteroids or other drugs that affect the immune system may be continued during treatment with Humira. Humira can be administered as monotherapy.
Children and adolescents from 2 years of age and weighing less than 30 kg	a 20 mg every other week n a i	The doctor may prescribe an initial dose of 40 mg to be administered one week before starting the usual dose of 20 mg every other week. The use of Humira is recommended in combination with methotrexate.
Children and adolescents from 2 years of age and weighing at least 30 kg a	l a 40 mg every other week t I	The doctor may prescribe an initial dose of 80 mg to be administered one week before starting the usual dose of 40 mg every other week. The use of Humira is recommended in combination with methotrexate.

How and route of administration
Humira is administered by injection under the skin (subcutaneous injection).

If you stop taking Humira
The decision to stop using Humira must be discussed with your doctor. Symptoms may
return if you stop using Humira.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Immediately inform your doctor if you notice any of the following reactions

severe skin rash, hives or other signs of an allergic reaction
swelling of the face, hands, feet
difficulty breathing, difficulty swallowing
shortness of breath on exertion or when lying down or swollen feet

Inform your doctor as soon as possible if you notice any of the following reactions

signs of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating
fatigue or weakness
cough
tingling
numbness
double vision
weakness of the arms or legs
swelling or open sore that does not heal
signs and symptoms suggesting the development of blood system disorders, such as persistent fever, bruising, bleeding, paleness

The symptoms described above may be signs of the following side effects, which have been observed
with Humira.

Very common(may affect more than 1 in 10 people)

reactions at the injection site (including pain, swelling, redness or itching)
respiratory tract infections (including cold, runny nose, sinusitis and pneumonia)
headache
abdominal pain
nausea and vomiting
skin rash
musculoskeletal pain

Common(may affect up to 1 in 10 people)

serious infections (including sepsis and influenza)
intestinal infections (including gastroenteritis)
skin infections (including cellulitis and Herpes Zoster infection)
ear infections
oral infections (including tooth infections and herpes simplex)
reproductive system infections
urinary tract infections
fungal infections
infections affecting the joints
benign tumors
skin cancer
allergic reactions (including seasonal allergies)
dehydration
mood changes (including depression)
anxiety
sleep disorders
sensory disturbances such as tingling, pricking or numbness
migraine
nerve root compression (including lower back pain and leg pain)
visual disturbances
eye inflammation
eyelid inflammation and eye swelling
dizziness (feeling of spinning or whirling)
feeling of a fast heartbeat
high blood pressure
hot flashes
bruise (blood accumulation outside blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heartburn)
acid reflux
dry eye syndrome (including dry eyes and dry mouth)
itching
itchy skin rash
contusion
skin inflammation (such as eczema)
nail breakage of fingers and toes
increased sweating
hair loss
onset or worsening of psoriasis
muscle spasms
blood in urine
kidney problems
chest pain
edema (fluid retention)
fever
reduced platelets in the blood, which increases the risk of bleeding or bruising
difficulty healing wounds

Uncommon(may affect up to 1 in 100 people)

opportunistic infections (including tuberculosis and other infections that occur when immune defenses are reduced)
neurological infections (including viral meningitis)
eye infections
bacterial infections
diverticulitis (inflammation and infection of the large intestine)
tumors
tumors of the lymphatic system
melanoma
immune system disorders that can affect the lungs, skin and lymph nodes (which most commonly present as sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (nervous system disorders)
stroke
hearing loss, ringing in the ears
irregular heartbeat such as palpitations
heart problems that can cause shortness of breath or swelling in the ankles
acute myocardial infarction
formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel
lung disease causing shortness of breath (including inflammation)
pulmonary embolism (blockage of a pulmonary artery)
pleural effusion (abnormal accumulation of fluid in the pleural space)
inflammation of the pancreas causing severe abdominal and back pain
difficulty swallowing
facial edema (swelling of the face)
inflammation of the gallbladder, gallstones
fatty liver
night sweats
scarring
abnormal muscle catabolism
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs)
interrupted sleep
impotence
inflammations

Rare(may affect up to 1 in 1,000 people)

leukemia (a cancer that affects the blood and bone marrow)
severe allergic reaction with shock
multiple sclerosis
neurological disorders (such as optic nerve inflammation and Guillain-Barré syndrome, which can cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
cardiac arrest
pulmonary fibrosis (scarring of the lungs)
intestinal perforation (hole in the intestine)
hepatitis
reactivation of hepatitis B
autoimmune hepatitis (inflammation of the liver caused by your own immune system)
cutaneous vasculitis (inflammation of the blood vessels in the skin)
Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash)
facial edema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome
angioedema (localized swelling of the skin)
lichenoid skin reaction (itchy reddish-purple rash)

Not known(frequency cannot be estimated based on available data)

T-cell hepatosplenic lymphoma (a rare blood cancer that is often fatal)
Merkel cell carcinoma (a type of skin cancer)
Kaposi's sarcoma, a rare form of cancer related to human herpesvirus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness)
Weight gain (weight gain has been small for most patients)

Some of the side effects observed with Humira may be asymptomatic and can only be
detected through blood tests.
These include:

Very common(may affect more than 1 in 10 people)

low white blood cell count
low red blood cell count
increased lipids in the blood
increased liver enzymes

Common(may affect up to 1 in 10 people)

increased white blood cell count
decreased platelet count
increased uric acid in the blood
alteration of sodium in the blood
decreased calcium in the blood
decreased phosphorus in the blood
increased sugar in the blood
increased lactate dehydrogenase in the blood
presence of autoantibodies in the blood
decreased potassium in the blood

Uncommon(may affect up to 1 in 100 people)

high levels of bilirubin in the blood (liver blood test)

Rare(may affect up to 1 in 1,000 people)

low white blood cell, red blood cell and platelet count

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell
your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Humira

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled pen can be
stored at room temperature (up to 25°C) for a maximum period of 14 days – make sure to
protect the medicine from light. Once it has been removed from the refrigerator to be stored at
room temperature, the pen must be used within 14 days or discarded, even if it is placed
back in the refrigerator.
You must record the date on which the pen is removed from the refrigerator for the first time and the date after which
the pen must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor or
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humira contains
The active ingredient is adalimumab.
The excipients are mannitol, polysorbate 80 and water for injections.

Description of the appearance of Humira pre-filled pen and contents of the pack
Humira 40 mg solution for injection in a pre-filled pen is supplied as a sterile solution of 40 mg of
adalimumab dissolved in 0.4 ml of solution.
The Humira pre-filled pen is a single-use pen in grey and purple colour containing a glass syringe
in which Humira is present. The pen is equipped with two caps – one grey marked with the
number ‘1’ and the other purple marked with the number ‘2’. On each side of the pen there is
a window through which the solution of Humira present inside the
syringe can be glimpsed.
The Humira pre-filled pen is available in packs containing 1, 2, 4 and 6 pre-filled pens.
The pack of 1 pre-filled pen contains 2 alcohol swabs (1 spare). The
packs of 2, 4 and 6 pre-filled pens are supplied with 1 alcohol swab for each
pre-filled pen. Not all pack sizes may be marketed.
Humira may be available in vial, pre-filled syringe and/or pre-filled pen.

Marketing authorisation holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000
Further details on this medicinal product are available on the website of the European Medicines
Agency: http://www.ema.europa.eu/ .

large characters> or
holder.

7. Humira Injection

The following instructions explain how to perform a subcutaneous self-injection of Humira using the pre-filled pen. First, read the instructions carefully and follow them step by step.
You will receive instructions from your doctor, nurse, or pharmacist on the self-administration technique.
Do not proceed with the injection on your own until you are sure you understand how to prepare and perform the injection.
After adequate instruction, the injection can be performed by you or by other people such as, for example, a family member or friend.
Use each pre-filled pen exclusively for one injection only.

Humira Pre-filled Pen
Grey cap 1 White sleeve
covering the needle White arrowPurple cap 2

Injection pen with separate components highlighted by numbered arrows from 1 to 4 to illustrate the

Needle Window for inspection Purple activation button
Do not use the pre-filled pen and contact your doctor or pharmacist if

the solution appears cloudy, has changed color, or contains flocculi and particles
the expiry date (Exp.) has been exceeded
the solution has been frozen or exposed to direct sunlight
the pre-filled pen has been dropped or damaged

Remove the cap only immediately before the injection. Keep Humira out of the sight and
reach of children.
STEP 1
Take Humira out of the refrigerator.
Before the injection, allow Humira to reach room temperature for 15 - 30 minutes.

Do notremove the grey cap and the purple cap while Humira reaches room temperature
Do notheat Humira in any other way. For example, do notheat Humira in the microwave or in hot water STEP 2

Pen
Check the expiry date (Exp.). Do notuse the pre-
filled pen if the expiry date has been exceeded.
Arrange the following items on a flat and clean surface

Auto-injector pen with protected needle and disinfecting wipe, detail of hand injecting the drug with the

1 single-use pre-filled pen
1 alcohol-soaked swab

Wash and dry your hands.

Swab
STEP 3
Injection areas
Choose an injection site:

On the front of the thigh or
On the abdomen (stomach) at a distance of at least 5 cm from the navel
At a distance of at least 3 centimeters from the last injection site chosen

Clean the injection site thoroughly with circular movements
using the alcohol-soaked swab.

Person with medical patches applied to abdomen and knees, enlarged detail of hand applying a patch

Do notinject through clothing
Do notinject on broken, bruised, reddened, hardened skin, with scars, stretch marks or in areas with plaque psoriasis

Injection areas
STEP 4
Hold the pre-filled pen with the grey cap (1) facing
upwards.
Check through the inspection window.

Injection pen in hand with magnification of the cartridge release mechanism and numeric indication on the body

It is normal to notice one or more bubbles in the window
Make sure the solution is clear and colorless
Do notuse the pre-filled pen if the solution appears cloudy or contains particles
Do notuse the pre-filled pen if it has been dropped or damaged

STEP 5
Cap 1
Remove the grey cap (1). Throw away the cap. Do not put the
cap back on.

Verify that the black protection covering the needle of the syringe has been removed together with the cap
It is normal for a few small drops of liquid to come out of the needle

Remove the purple cap (2). Throw away the cap. Do not put the
cap back on.
The pre-filled pen is now ready for use.
Rotate the pre-filled pen so that the white arrow
is facing towards the injection site.

Disassembled injection pen with arrows indicating the detachment of the cap and the

Cap 2
STEP 6
With the other hand, grasp the skin at the injection site to
create a raised area and hold it firmly until the
injection is complete.
Position the white arrow towards the injection site (thigh or
abdomen).
Position the white sleeve covering the needle at a right angle

(90˚ angle)to the injection site.

Hand holding an injection pen, 90-degree angle indicated, detail of the

Hold the pre-filled pen so that you can see the
inspection window.

Do notpress the purple activation button until you are
ready to perform the injection.

STEP 7
10 Seconds
Press the pre-filled pen firmlyagainst the injection
site before starting the injection.

Continue to hold downto prevent the pre-filled
pen from moving away from the skin during the injection.

Pressthe purple activation button and count slowly to

10seconds.

Subcutaneous injection with syringe, needle inserted at a low angle, arrow indicates the direction and detail of the

ri>

A strong “click”will indicate the start of the injection
Continue to holdthe pre-filled pen firmlyagainst the injection site until the injection is complete.

The injection will be complete when the yellow indicator has
stopped moving.
♦

STEP 8
Once the injection is complete, slowly withdraw the
pre-filled pen from the skin. The white sleeve covering
the needle will cover the tip of the needle.

Hand holding a self-administering injection device pressed against the thigh with a black arrow indicating the direction

The presence of a small amount of liquid at the injection site is normal

If there is more than a few drops at the injection site, contact your doctor, nurse, or pharmacist.
After completing the injection, apply a cotton ball
or gauze to the skin at the injection site.

Do notrub
A slight bleeding at the injection site is normal STEP 9

Dispose of the used pre-filled pen in a special container following the instructions of your doctor,
nurse, or pharmacist.

Do notrecycle or dispose of the pre-filled pen in household waste
Alwayskeep the pre-filled pen and the special container out of the sight and reach of children

The caps, alcohol-soaked swabs, cotton wool or gauze, blister and packaging
can be disposed of in household waste.

Humira 80 mg injectable solution in pre-filled syringe

adalimumab

Read this leaflet carefully before using this medicine as it contains important
information for you

Keep this leaflet. You may need to read it again.
Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before starting to take Humira and during treatment with Humira. Keep this Patient Reminder Card.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Humira is and what it is used for
2. What you need to know before you use Humira
3. How to use Humira
4. Possible side effects
5. How to store Humira
6. Contents of the pack and other information
7. Humira injection

1. What is Humira and what is it used for?

Humira contains the active ingredient adalimumab.
Humira is used for the treatment of

Rheumatoid arthritis
Plaque psoriasis
Hidradenitis suppurativa
Crohn’s disease
Ulcerative colitis
Non-infectious uveitis

Plaque psoriasis
Plaque psoriasis is a skin condition that causes reddish, scaly, and hardened patches of
skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to
break, thicken, and lift from the nail bed, which can be painful.
Humira is used to treat chronic moderate to severe plaque psoriasis in adults.

Hidradenitis Suppurativa
Hidradenitis Suppurativa (sometimes called inverse acne) is a chronic inflammatory disease of the
skin and is often painful. Symptoms may include painful nodules and abscesses (cysts) that may
drain pus. It most frequently affects specific areas of the skin, such as the underarm area,
armpits, inner thighs, groin, and buttocks. Scars may also form in the affected areas.
Humira is used to treat:

Moderate to severe Hidradenitis Suppurativa in adults and
Moderate to severe Hidradenitis Suppurativa in adolescents aged 12 to 17 years.

Humira may reduce the number of nodules and abscesses caused by the disease and the pain that is often
associated with this disease. Other medications may be taken initially. If the response to these
drugs is not adequate, you will be given Humira.

Crohn’s disease
Crohn’s disease is an inflammation of the digestive tract.
Humira is used to treat:

Moderate to severe Crohn’s disease in adults
Moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.

Other medications may be taken initially. If the response to these drugs is not
adequate, you will be given Humira to treat Crohn’s disease.

Ulcerative colitis
Ulcerative colitis is an inflammation of the large intestine.
Humira is used to treat

Moderate to severe ulcerative colitis in adults and
Moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years

Other medications may be taken initially. If the response to these drugs is not
adequate, you will be given Humira.

Non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Humira is used for the treatment of:

Adults with non-infectious uveitis with inflammation affecting the back of the eye
Children aged 2 years and older with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation can lead to a decrease in vision and/or the presence of floaters
in the eye (small dark spots or thin lines that move across the field of vision). Humira works
by reducing this inflammation. You will first be given other medications. If you do not
respond adequately to these medications, you will be given Humira.

2. What you need to know before using Humira

Do not use Humira:

If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
If you have active tuberculosis or other serious infections (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, dental problems.
If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Humira
Allergic reactions

If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not take Humira again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

If you have an infection, including long-term infections or an infection in one part of your body (for example, leg ulcers), consult your doctor before starting treatment with Humira. If you have doubts, contact your doctor.
You may be more likely to get infections during treatment with Humira. This risk may increase if you have lung problems. These infections can be serious and include:
tuberculosis,
infections caused by viruses, fungi, parasites or bacteria,
serious blood infections (sepsis)

Tell your doctor if you live or travel to regions where fungal infections are very common (e.g. histoplasmosis, coccidioidomycosis or blastomycosis).
Tell your doctor if you have had infections that keep recurring or if you have other conditions that increase your risk of infection.
If you are over 65 years old, you may be more likely to get infections while taking Humira. You and your doctor should pay particular attention to signs of infection during treatment with Humira. It is important to tell your doctor if you develop symptoms of infections such as fever, wounds, feeling tired or dental problems.

Tuberculosis

It is very important to tell your doctor if you have ever had tuberculosis, or if you have been in contact with someone who has had tuberculosis. You should not take Humira if you have active tuberculosis.
Because cases of tuberculosis have occurred in patients treated with Humira, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Humira. This will involve a thorough medical assessment of your medical history and appropriate clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card.
Tuberculosis can develop during therapy even if you have received treatment to prevent tuberculosis.
Contact your doctor immediately if symptoms of tuberculosis (e.g. cough that does not go away, weight loss, lack of energy, mild fever) or other infections appear during or after therapy.

Hepatitis B

Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus, or if you think you may be at risk of contracting the hepatitis B virus.
Your doctor should test you for hepatitis B virus infection. In HBV carriers, taking Humira may cause the virus to reactivate.
In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of the hepatitis B virus can be life-threatening.

Surgery or dental procedures

Before surgery or dental procedures, tell your doctor that you are taking Humira. Your doctor may advise you to temporarily stop Humira.

Demyelinating diseases

If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Humira. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccinations

Certain vaccines can cause infections and should not be given during treatment with Humira.
Consult your doctor before getting vaccinated.
It is recommended, if possible, to have children vaccinated for all ages before starting treatment with Humira.
If you have taken Humira during pregnancy, the baby may be at increased risk of contracting an infection up to about 5 months after the last dose of Humira given. It is important that you tell your pediatrician or other healthcare provider about your use of Humira during pregnancy, so they can decide when the baby should receive any type of vaccination.

Heart failure

If you have mild heart failure and are treated with Humira, the condition of your heart failure must be carefully monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new symptoms of heart failure or if existing symptoms worsen (e.g. shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide whether you should take Humira.

Fever, bruising, bleeding or paleness

In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. Your doctor may decide to stop therapy. If you have a persistent fever, bruising or easy bleeding, or paleness, see your doctor immediately.

Tumors

In patients, both children and adults, undergoing treatment with Humira or other anti-TNF drugs, some types of tumors have occurred very rarely.
Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma (a cancer that affects the lymphatic system) and leukemia (a cancer that affects the blood and bone marrow).
If you are taking Humira, the risk of developing lymphoma, leukemia, or other tumors may increase. In rare circumstances, a rare and serious type of lymphoma has been observed in patients treated with Humira. Some of these patients were also being treated with azathioprine or 6-mercaptopurine.
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
Cases of non-melanoma skin cancer have been observed in patients taking Humira.
If new skin lesions appear during or after therapy, or if the appearance of existing lesions changes, tell your doctor.
Cases of neoplasms, in addition to lymphoma, have occurred in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another anti-TNF.

If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with
an anti-TNF is appropriate.
Autoimmune disease

Rarely, treatment with Humira can lead to the manifestation of a syndrome like lupus. Tell your doctor if you develop symptoms such as a persistent unexplained rash, fever, joint pain, or fatigue.

Children and adolescents

Vaccinations: if possible, children should have had all vaccinations before using Humira.

anakinra
abatacept.

Humira can be used with:

methotrexate
other disease-modifying antirheumatic drugs (e.g. sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts)
steroids or pain relievers, including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have doubts, ask your doctor.

Pregnancy and breastfeeding

You should consider using adequate contraception to prevent pregnancy and continue using it for at least 5 months after the last therapy with Humira.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice on taking this medicine.
Humira should only be used during pregnancy if necessary.
According to a pregnancy study, no increased risk of birth defects was found when the mother had received Humira during pregnancy, compared to mothers with the same condition who had not received Humira.
Humira can be used during breastfeeding.
If you take Humira during pregnancy, the baby may be at increased risk of contracting an infection.
It is important that you tell your pediatrician or other healthcare provider about your use of Humira during pregnancy, before the baby receives any type of vaccination. For more information on vaccinations, see “Warnings and precautions”.

Driving and using machines
Humira may affect, although only to a modest extent, your ability to drive, ride a bicycle
or use machines. After taking Humira, you may experience vision disturbances and a
sensation that the environment around you is rotating.

3. How to use Humira

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Humira for each of the approved uses are shown in the table below.
Your doctor may prescribe a different dosage of Humira if needed.

a Rheumatoid arthritis
Age or body weight	How much should be taken and how often?	m Notes
Adults	40 mg every other week l e d a	In rheumatoid arthritis, it is r recommended to continue taking a methotrexate during treatment with Humira. If the F doctor decides that methotrexate is not appropriate, Humira can be administered alone. If you have rheumatoid arthritis and are not taking methotrexate in combination with Humira, your doctor may decide to prescribe 40 mg of Humira every week or 80 mg every other week.

n Plaque psoriasis
Age or body weight	a How much should be taken and how often?	Note
Adults	i The first dose of 80 mg l (an 80 mg injection), a followed by 40 mg every other t week, starting one week after the first dose.	If you have an insufficient response, the doctor may increase the dosage to 40 mg every week or 80 mg every other week.

Hidradenitis suppurativa
a Age or body weight	How much should be taken and how often?	Note
i Adults z n e g A	The first dose of 160 mg (two 80 mg injections in one day or an 80 mg injection per day for two consecutive days), followed by a dose of 80 mg (an 80 mg injection) two weeks later. After another two weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by the doctor.	It is recommended to perform daily antiseptic washing on the affected areas.

Adolescents aged between 12 and 17 years weighing 30 kg or more

The first dose of 80 mg (an 80 mg injection), followed by 40 mg every other week starting one week later.

If you have an insufficient response to 40 mg of Humira every other o week, the doctor may increase the dosage to a 40 mg every week or 80 mg every other week. a It is recommended to perform m daily antiseptic washing on the affected areas.

Crohn’s disease
Age or body weight	How much should be taken and how often?	r a Note
Children, adolescents and adults a aged 6 years or older weighing 40 kg or more	The first dose of 80 mg (an 80 mg injection), followed by 40 mg two weeks l later. e If a faster response is needed, the doctor may d prescribe a first dose of 160 mg (two 80 mg injections in one day or an 80 mg injection a per day for two consecutive days), followed by 80 mg n (an 80 mg injection) two weeks later. a Subsequently, the usual dose is 40 mg every other week.	F The doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Children and adolescents aged between 6 and 17 years weighing less than 40 kg a i z n	l a The first dose of 40 mg, followed by 20 mg two weeks t later. I If a faster response is needed, the doctor may prescribe a first dose of 80 mg (an 80 mg injection), followed by 40 mg two weeks later. Subsequently, the usual dose is 20 mg every other week.	The doctor may increase the frequency of the dose to 20 mg every week.

Ulcerative colitis
Age or body weight	How much should be taken and how often?	Note
Adults	The first dose of 160 mg (two 80 mg injections in one day or an 80 mg injection per day for two consecutive days), followed by 80 mg (an 80 mg injection) two weeks later. Subsequently, the usual dose is 40 mg every other week.	o The doctor may increase the c dosage to 40 mg every week or 80 mg every other a week. m r
Children and adolescents aged 6 years or older weighing less than 40 kg	An initial dose of 80 mg (an 80 mg injection), followed by 40 mg (a 40 mg injection) two weeks later. l Subsequently, the usual dose is 40 mg every other week.	a It is recommended to continue taking F Humira at the usual dose, even after turning 18 years of age.
Children and adolescents aged 6 years or older weighing 40 kg or more	d An initial dose of 160 mg (two 80 mg injections in one day or an 80 mg injection per day for two consecutive days), followed by 80 mg n (an 80 mg injection) two weeks later. a Subsequently, the usual dose is 80 mg every other week.	It is recommended to continue taking Humira at the usual dose, even after turning 18 years of age.

a Non-infectious uveitis
Age or body weight	t How much should be taken and how often?	Note
Adults a i	I The first dose of 80 mg (an 80 mg injection), followed by 40 mg every other week starting one week after the first dose.	The use of corticosteroids or other medicines that affect the immune system may be continued while using Humira. Humira can also be administered alone.
z Children and adolescents aged 2 years or older weighing less than 30 kg e g	20 mg every other week	The doctor may prescribe an initial dose of 40 mg to be administered one week before starting the usual dose of 20 mg every other week. The use of Humira is recommended in combination with methotrexate.
A Children and adolescents aged 2 years or older weighing 30 kg or more	40 mg every other week	The doctor may prescribe an initial dose of 80 mg to be administered one week before starting the usual dose of 40 mg every other week. The use of Humira is

How and route of administration
Humira is administered by injection under the skin (subcutaneous injection).

Detailed instructions for injecting Humira can be found in section 7 “Injecting Humira”.
If you use more Humira than you should
If you accidentally inject Humira more frequently than prescribed by your doctor or pharmacist,
contact your doctor or pharmacist informing them that you have taken more medicine. Always keep the box
of the medicine, even if empty.

If you stop taking Humira
The decision to stop using Humira should be discussed with your doctor. Symptoms may
return if you stop taking Humira.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild to moderate. However, some can be serious and require treatment. Side effects may occur
up to 4 months after the last injection of Humira.

Tell your doctor immediately if you notice any of the following reactions

severe skin rash, hives or other signs of an allergic reaction
swelling of the face, hands, feet
difficulty breathing, difficulty swallowing
shortness of breath during physical activity or when lying down or swollen feet.

Tell your doctor as soon as possible if you notice any of the following reactions

signs of infection such as fever, feeling unwell, sores, dental problems, burning when urinating
fatigue or weakness
cough
tingling
numbness
double vision
weakness of the arms or legs
swelling or open sore that does not heal
signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, paleness

recommended in association with methotrexate.

The symptoms described above may be signs of the following side effects, which have been observed
with Humira.

Very common(may affect more than 1 in 10 people)

reactions at the injection site (including pain, swelling, redness or itching)
respiratory tract infections (including cold, runny nose, sinusitis and pneumonia)
headache
abdominal pain
nausea and vomiting
skin rash
musculoskeletal pain

Common(may affect up to 1 in 10 people)

serious infections (including sepsis and influenza)
intestinal infections (including gastroenteritis)
skin infections (including cellulitis and herpes zoster infection)
ear infections
oral infections (including tooth infections and herpes simplex)
infections of the reproductive system
urinary tract infections
fungal infections
infections affecting the joints
benign tumors
skin cancer;
allergic reactions (including seasonal allergy)
dehydration
mood changes (including depression)
anxiety
sleep disorders
sensory disturbances such as tingling, stabbing sensation or numbness
migraine
nerve root compression (including lower back pain and leg pain)
visual disturbances
eye inflammation
eyelid inflammation and eye swelling
dizziness (feeling faint or lightheaded)
feeling of a fast heartbeat
high blood pressure
hot flashes
bruise (blood collection outside blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heartburn)
acid reflux
dry eye syndrome (including dry eyes and dry mouth)
itching
itchy skin rash
contusion
skin inflammation (such as eczema)
nail breakage of the fingers and toes
increased sweating
hair loss
onset or worsening of psoriasis
muscle spasms
blood in urine
kidney problems
chest pain
edema (swelling)
fever
low platelet count in the blood which increases the risk of bleeding or bruising
difficulty healing wounds

Uncommon(may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when the immune defenses are reduced)
neurological infections (including viral meningitis)
eye infections
bacterial infections
diverticulitis (inflammation and infection of the large intestine)
tumors
tumors of the lymphatic system
melanoma
immune system disorders that can affect lungs, skin and lymph nodes (which most commonly present as sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor
neuropathy (nerve disorder)
stroke
hearing loss, ringing in the ears
irregular heartbeat such as palpitations
heart problems that can cause shortness of breath or swelling in the ankles
acute myocardial infarction
formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel
lung disease that causes shortness of breath (including inflammation)
pulmonary embolism (blockage of a pulmonary artery)
pleural effusion (abnormal collection of fluid in the pleural space)
inflammation of the pancreas that causes severe pain in the abdomen and back
difficulty swallowing
facial edema (swelling of the face)
inflammation of the gallbladder, gallstones
fatty liver
night sweats
scarring
abnormal muscle catabolism
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs)
interrupted sleep
impotence
inflammations

Rare(may affect up to 1 in 1,000 people)

leukemia (a cancer that affects the blood and bone marrow)
severe allergic reaction with shock
multiple sclerosis
neurological disorders (such as optic nerve inflammation and Guillain-Barré syndrome which can cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
cardiac arrest
pulmonary fibrosis (scarring of the lungs)
intestinal perforation (hole in the intestine)
hepatitis
reactivation of hepatitis B
autoimmune hepatitis (inflammation of the liver caused by your own immune system);
cutaneous vasculitis (inflammation of the blood vessels of the skin)
Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash)
facial edema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome
angioedema (localized swelling of the skin)
lichenoid skin reaction (itchy red-purple skin rash)

Not known(frequency cannot be estimated from the available data)

T-cell hepatic-splenic lymphoma (a rare blood cancer that is often fatal)
Merkel cell carcinoma (a type of skin cancer)
Kaposi's sarcoma, a rare cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness)
Weight gain (weight gain has been low for most patients)

Some of the side effects observed with Humira may be asymptomatic and can only be
detected through blood tests.
These include:

Very common(may affect more than 1 in 10 people)

low white blood cell count
low red blood cell count
increased lipids in the blood
increased liver enzymes

Common(may affect up to 1 in 10 people)

increased white blood cell count
decreased platelet count
increased uric acid in the blood
alteration of sodium in the blood
decreased calcium in the blood
decreased phosphorus in the blood
increased sugar in the blood
increased lactate dehydrogenase in the blood
presence of autoantibodies in the blood
decreased potassium in the blood

Uncommon(may affect up to 1 in 100 people)

high levels of bilirubin in the blood (liver blood test)

Rare(may affect up to 1 in 1,000 people)

low white blood cell, red blood cell and platelet counts

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Humira

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2  C – 8  C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled syringe can be stored
at room temperature (up to 25°C) for a maximum period of 14 days – ensure that the
medicine is protected from light. Once it has been removed from the refrigerator to be stored at room
temperature, the syringe must be used within 14 days or discarded, even if it is placed back in the
refrigerator.
You must record the date on which the syringe is removed from the refrigerator for the first time and the date after which
the syringe must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor or pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humira contains
The active ingredient is adalimumab.
The excipients are mannitol, polysorbate 80 and water for injections.

Description of the appearance of Humira pre-filled syringe and contents of the pack
Humira 80 mg solution for injection in pre-filled syringes is supplied as a sterile solution of 80 mg of
adalimumab dissolved in 0.8 ml of solution.
Humira pre-filled syringe consists of a solution of adalimumab contained in a glass syringe.
The Humira pre-filled syringe is available in a pack containing 1 pre-filled syringe
for use by patients with an alcohol-soaked wipe.
Humira may be available in a vial, in a pre-filled syringe and/or in a pre-filled pen.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .

large characters> or

7. Humira Injection

The following instructions explain how to perform a subcutaneous self-injection of Humira using the pre-filled syringe. First, read the instructions carefully and follow them step by step.
You will receive instructions from your doctor, nurse, or pharmacist on the self-administration technique.
Do not proceed with the injection on your own until you are sure you understand how to prepare and administer the injection.
After adequate instruction, the injection can be performed by you or by other people, such as a family member or friend.
Use each pre-filled syringe exclusively for a single injection.

Humira pre-filled syringe
PlungerFinger gripNeedle cap

Prefilled syringe with spring-loaded plunger and metallic needle protected by a grey safety cap

Do not use the pre-filled syringe and contact your doctor or pharmacist if

the solution appears cloudy, has changed color, or contains flocculi and particles
the expiration date (Exp.) has been exceeded
the solution has been frozen or exposed to direct sunlight
the pre-filled syringe has been dropped or damaged

Remove the needle cap only immediately before the injection. Keep Humira out of the
sight and reach of children.
STEP 1
Remove Humira from the refrigerator.
Before performing the injection, allow Humira to reach room temperature for 15-30 minutes.

Donot remove the needle cap while waiting for Humira to reach room temperature
Donot heat Humira in other ways. For example, donot heat in the microwave or hot water.

STEP 2
Syringe
Check the expiration date (Exp.). Donot use the pre-
filled syringe if the expiration date (Exp.) has been exceeded.
Arrange the following items on a clean, flat surface

Prefilled syringe in a transparent blister with a visible plunger and a protected needle, next to an opened package and a hand extracting it

1 single-use pre-filled syringe
1 alcohol swab

Wash and dry your hands.

Swab
STEP 3
Injection areas
Choose an injection site:

On the front of the thigh or
On the abdomen (stomach) at least 5 cm from the navel
At least 3 cm from the last injection site

Rub the injection site with circular motions,
using the alcohol swab.

Person with medicated patches applied to abdomen and knees, detailed close-up of a hand applying a patch

Donot inject through clothing
Donot inject into areas where the skin appears red or hardened, there are bruises, ulcers, scars, stretch marks, or areas with plaque psoriasis

Injection areas
STEP 4Hold the pre-filled syringe with one hand.
Check the liquid in the pre-filled syringe.

Make sure the liquid is clear and colorless
Donot use the pre-filled syringe if the liquid is cloudy or contains particles
Donot use the pre-filled syringe if it has been dropped or crushed

Gently remove the needle cap from the syringe with
your other hand. Dispose of the cap. Do not reuse the cap.

Donot touch the needle with your fingers, and make sure the needle does not come into contact with anything

STEP 5Hold the pre-filled syringe with the needle pointing
upward.

Hand holding an injection device with a transparent needle and a cross-shaped support for subcutaneous administration

Hold the pre-filled syringe at eye level with one hand, so you can see the air in the pre-filled syringe

Slowly push the plunger to expel the air through
the needle.

It is normal to see a drop of liquid at the end of the needle

STEP 6Hold the pre-filled syringe with one hand between the thumb and
index finger, like a pencil.
With your other hand, grasp the skin at the injection site to lift it and hold it firmly

Hand holding a self-injector with exposed needle and a detailed close-up of the injection point on the skin

STEP 7Insert the needle completely into the skin with
an angle of approximately 45° with a quick and
decisive movement.

Subcutaneous injection with a syringe at a 45-degree angle in the arm, angle indicated, detail of the hand performing it

When the needle is inserted, release the skin.

Push the plunger completely until all the
liquid has been injected and the pre-filled syringe is empty.

Subcutaneous injection with a syringe: hand holding the syringe and the

Donot rub
It is normal for slight bleeding to occur at the injection site

Cotton ball
STEP 9
Dispose of the used pre-filled syringe in a special container, according to the instructions of your doctor,
nurse, or pharmacist. Never recap the needle.

Donot recycle or dispose of the pre-filled syringe in household waste
Always keep the pre-filled syringe and the special waste container out of the sight and reach of children.

The needle cap, alcohol swab, cotton ball or gauze, blister, and
packaging can be disposed of in household waste.

Humira 80 mg solution for injection in pre-filled pen

adalimumab

Read this leaflet carefully before you start using this medicine as it contains important
information for you

Keep this leaflet. You may need to read it again.
Your doctor will give you a Patient Reminder Card, which contains important safety information that you need to know before starting to take Humira and during treatment with Humira. Keep this Patient Reminder Card.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed only for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Humira is and what it is used for
2. What you need to know before you use Humira
3. How to use Humira
4. Possible side effects
5. How to store Humira
6. Contents of the pack and other information
7. Injecting Humira

1. What is Humira and what is it used for

Humira contains the active ingredient adalimumab.
Humira is used for the treatment of:

Rheumatoid arthritis
Plaque psoriasis
Hidradenitis suppurativa
Crohn’s disease
Ulcerative colitis
Non-infectious uveitis

Hidradenitis Suppurativa of moderate to severe grade in adults and
Hidradenitis Suppurativa of moderate to severe grade in adolescents aged between 12 and 17 years.

Humira may reduce the number of nodules and abscesses caused by the disease, and the pain that is often
associated with this disease. Other medications may be taken initially. If the response to these
drugs is not adequate, you will be given Humira.

Crohn’s disease
Crohn’s disease is an inflammation of the digestive tract.
Humira is used to treat:

Crohn’s disease of moderate to severe grade in adults
Crohn’s disease of moderate to severe grade in children and adolescents aged between 6 and 17 years.

Initially, other medications may be taken. If the response to these drugs is not
adequate, you will be given Humira to treat Crohn’s disease.

Ulcerative colitis
Ulcerative colitis is an inflammation of the large intestine.
Humira is used to treat

ulcerative colitis of moderate to severe grade in adults and
ulcerative colitis of moderate to severe grade in children and adolescents aged between 6 and 17 years.

Initially, other medications may be taken. If the response to these drugs is not
adequate, you will be given Humira.

Non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Humira is used for the treatment of:

Adults with non-infectious uveitis with inflammation affecting the back of the eye.
Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

This inflammation can lead to a decrease in vision and/or the presence of mobile bodies
in the eye (black spots or thin lines that move across the visual field). Humira works
by reducing this inflammation. You will first be given other medications. If you do not
respond adequately to these medications, you will be given Humira.

2. What you need to know before using Humira

Do not use Humira:

If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
If you have active tuberculosis or other serious infections (see “Warnings and precautions”). It is important to tell your doctor if you have signs or symptoms of infection, such as fever, wounds, feeling tired, dental problems.
If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Humira
Allergic reactions

If you experience allergic reactions with symptoms such as a feeling of tightness in the chest, wheezing, dizziness, swelling or skin rash, do not take Humira anymore and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

If you have an infection, including long-term infections or an infection in a part of your body (for example, leg ulcers), consult your doctor before starting treatment with Humira. If you have doubts, contact your doctor.
You may be more likely to get infections during treatment with Humira. This risk may increase if you have lung problems. These infections can be serious and include:
tuberculosis,
infections caused by viruses, fungi, parasites or bacteria,
serious infections in the blood (sepsis)

Tell your doctor if you live or travel to regions where fungal infections are very common (e.g. histoplasmosis, coccidioidomycosis or blastomycosis).
Tell your doctor if you have had infections that keep recurring or if you have other conditions that increase the risk of infection.
If you are over 65 years old, you may be more likely to get infections while taking Humira. You and your doctor should pay particular attention to signs of infection during treatment with Humira. It is important to tell your doctor if you develop symptoms of infections such as fever, wounds, feeling tired or dental problems.

Tuberculosis

It is very important to tell your doctor if you have ever had tuberculosis, or if you have been in contact with someone who has had tuberculosis. You should not take Humira if you have active tuberculosis.
Because cases of tuberculosis have occurred in patients treated with Humira, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Humira. This will involve a thorough medical assessment of your medical history and appropriate clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the Patient Reminder Card.
Tuberculosis may develop during therapy even if you have received treatment to prevent tuberculosis.
Contact your doctor immediately if symptoms of tuberculosis (e.g. cough that does not go away, weight loss, lack of energy, mild fever) or other infections appear during or after therapy.

Hepatitis B

Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis B virus.
Your doctor should test you for hepatitis B virus infection. In carriers of HBV, taking Humira may cause the virus to reactivate.
In some rare cases, especially if the patient is undergoing therapy with other drugs that suppress the immune system, reactivation of the hepatitis B virus can be life-threatening.

Surgery or dental procedures

Before surgery or dental procedures, tell your doctor that you are taking Humira. Your doctor may advise you to temporarily stop Humira.

Demyelinating diseases

If you have or develop a demyelinating disease (a disease that affects the insulating layer around nerves, such as multiple sclerosis), your doctor will decide whether to start or continue treatment with Humira. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness of arms or legs, or numbness or tingling that affects any part of the body.

Vaccinations

Certain vaccines can cause infections and should not be given during treatment with Humira.
Consult your doctor before getting vaccinated.
It is recommended, if possible, to give children all the vaccinations recommended for their age before starting treatment with Humira.
If you have taken Humira during pregnancy, the baby may have a higher risk of contracting infection up to about 5 months after the last dose of Humira given. It is important that you tell your pediatrician or other healthcare provider about your use of Humira during pregnancy so that they can decide when the baby should receive any type of vaccination.

Heart failure

If you have mild heart failure and are being treated with Humira, the state of your heart failure must be carefully monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new symptoms of heart failure or if existing symptoms worsen (e.g. shortness of breath or swelling of the feet), contact your doctor immediately. Your doctor will decide if you can take Humira.

Fever, bruising, bleeding or paleness

In some patients, the body may not be able to produce enough blood cells to fight infections or stop bleeding. Your doctor may decide to stop therapy. If you have persistent fever, bruising or easy bleeding or paleness, see your doctor immediately.

Tumors

In patients, both children and adults, treated with Humira or other anti-TNF drugs, some types of tumors have occurred very rarely.
Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma (a tumor that affects the lymphatic system) and leukemia (a tumor that affects the blood and bone marrow).
If you take Humira, the risk of developing lymphomas, leukemia or other tumors may increase. In rare circumstances, a rare and serious type of lymphoma has been observed in patients treated with Humira. Some of these patients were also being treated with azathioprine or 6-mercaptopurine.
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Humira.
Cases of non-melanoma skin cancer have been observed in patients taking Humira.
If new skin lesions appear during or after therapy or if the appearance of existing lesions changes, report it to your doctor.
Cases of neoplasms, in addition to lymphoma, have occurred in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another anti-TNF.

If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with
an anti-TNF is appropriate.
Autoimmune disease

Rarely, treatment with Humira can lead to the manifestation of a syndrome like lupus. Tell your doctor if you develop symptoms such as a persistent unexplained rash, fever, joint pain or fatigue.

Children and adolescents

Vaccinations: if possible, children should have already had all vaccinations before using Humira.

anakinra
abatacept.

Humira can be taken with:

methotrexate
other disease-modifying antirheumatic drugs (e.g. sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts)
steroids or pain relievers, including non-steroidal anti-inflammatory drugs (NSAIDs). If you have doubts, ask your doctor.

Pregnancy and breastfeeding

You should consider using adequate contraceptive measures to prevent pregnancy and continue using them for at least 5 months after the last therapy with Humira.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice on taking this medicine.
Humira should only be used during pregnancy if necessary.
According to a pregnancy study, no increased risk of birth defects was found when the mother received Humira during pregnancy, compared to mothers with the same condition who had not received Humira.
Humira can be used during breastfeeding.
If you take Humira during pregnancy, the baby may have a higher risk of contracting an infection.
It is important that you tell your pediatrician or other healthcare provider about your use of Humira during pregnancy before the baby receives any type of vaccination. For more information on vaccinations, see “Warnings and precautions”.

Driving and using machines
Humira may affect, albeit only to a modest extent, your ability to drive, cycle
or use machines. After taking Humira, you may experience visual disturbances and a
sensation that the environment around you is spinning.

3. How to use Humira

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended doses of Humira for each of the approved uses are shown in the table
below. Your doctor may prescribe a different dosage of Humira if needed.

a Rheumatoid arthritis
Age or body weight	How much should be taken and how often?	m Notes
Adults	40 mg every other week l e d a	In rheumatoid arthritis, it is r continued to take the a methotrexate during the treatment with Humira. If the F doctor decides that methotrexate is not appropriate, Humira can be administered alone. If you have rheumatoid arthritis and are not taking methotrexate in association with Humira, your doctor may decide to prescribe 40 mg of Humira every week or 80 mg every other week.

n Plaque psoriasis
Age or body weight	a How much should be taken and how often?	Notes
Adults	i The first dose of 80 mg l (an 80 mg injection), a followed by 40 mg every other week, starting one t week after taking the first dose.	If you have an insufficient response, the doctor may increase the dosage up to 40 mg every week or 80 mg every other week.

Hidradenitis suppurativa
a Age or body weight	Che quantità ne va assunta e con che frequenza?	Note
i Adults z n e g A	The first dose of 160 mg (two 80 mg injections in one day or an 80 mg injection for two consecutive days), followed by a dose of 80 mg (an 80 mg injection) two weeks later. After another two weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by the doctor.	It is recommended to perform daily antiseptic washing on the affected areas.

Adolescents aged between 12 and 17 years, weighing 30 kg or more

The first dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week later.

If you have an insufficient response to 40 mg of Humira every other o week, the doctor may increase the dosage up to c 40 mg every week or 80 mg every other week. a It is recommended to perform m daily antiseptic washing on the affected areas.

Crohn’s disease
Age or body weight	How much should be taken and how often?	r a Notes
Children, adolescents and adults aged between 6 and 17 years and weighing 40 kg or more	The first dose of 80 mg (an 80 mg injection), followed by 40 mg two weeks l later. e If a faster response is needed, the doctor may d prescribe a first dose of 160 mg (two 80 mg injections in one day or an 80 mg injection a for two consecutive days), followed by 80 mg n (an 80 mg injection) two weeks later. a Subsequently, the usual dose i is 40 mg every other week.	F The doctor may increase the dosage up to 40 mg every week or 80 mg every other week.
Children and adolescents aged between 6 and 17 years and weighing less than 40 kg a i z n	l a The first dose of 40 mg, followed by 20 mg two weeks t later. I If a faster response is needed, the doctor may prescribe a first dose of 80 mg (an 80 mg injection), followed by 40 mg two weeks later. Subsequently, the usual dose is 20 mg every other week.	The doctor may increase the frequency of the dose up to 20 mg every week.

Ulcerative colitis
Age or body weight	How much should be taken and how often?	Note
Adults	The first dose of 160 mg (two 80 mg injections in one day or an 80 mg injection for two consecutive days), followed by 80 mg (an 80 mg injection) two weeks later. Subsequently, the usual dose is 40 mg every other week.	o The doctor may increase the c dosage up to 40 mg every week or 80 mg every other a week. m r
Children and adolescents starting from 6 years of age weighing less than 40 kg	An initial dose of 80 mg (one 80 mg injection), followed by 40 mg (one 40 mg injection) two weeks later. l Subsequently, the usual dose e is 40 mg every other week.	a It is recommended to continue F taking Humira at the usual dose, even after turning 18 years of age.
Children and adolescents starting from 6 years of age weighing 40 kg or more	An initial dose of 160 mg (two 80 mg injections in one day or an 80 mg injection for two consecutive days), followed by 80 mg n (one 80 mg injection) two weeks later. a Subsequently, the usual dose i is 80 mg every other week.	It is recommended to continue taking Humira at the usual dose, even after turning 18 years of age.

a Non-infectious uveitis
Age or body weight	t How much should be taken and how often?	Note
Adults a i	I The first dose of 80 mg (an 80 mg injection), followed by 40 mg every other week starting one week after the first dose.	The use of corticosteroids or other medicines that affect the immune system can be continued while using Humira. Humira can also be administered alone.
z Children and adolescents starting n from 2 years of age and weighing less than 30 kg e g	20 mg every other week	The doctor may prescribe an initial dose of 40 mg to be administered one week before starting the usual dose of 20 mg every other week. The use of Humira is recommended in association with methotrexate.
A Children and adolescents starting from 2 years of age and weighing 30 kg or more	40 mg every other week	The doctor may prescribe an initial dose of 80 mg to be administered one week before starting the usual dose of 40 mg every other week. The use of Humira is

How and route of administration
Humira is administered by injection under the skin (subcutaneous injection).

If you forget to use Humira
If you forget to give an injection, you should inject the next dose of Humira as soon as you remember.
Then resume the dose regularly according to the prescribed dosage schedule.

If you stop taking Humira
The decision to stop using Humira must be discussed with your doctor. Symptoms may
return if you stop taking Humira.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Tell your doctor immediately if you notice any of the following reactions

severe skin rash, hives or other signs of an allergic reaction
swelling of the face, hands, feet
difficulty breathing, difficulty swallowing
shortness of breath during physical activity or when lying down or swollen feet.

Tell your doctor as soon as possible if you notice any of the following reactions

signs of infection such as fever, feeling unwell, sores, dental problems, burning when urinating
fatigue or weakness
cough
tingling
numbness
double vision
weakness of the arms or legs
sore or open wound that does not heal
signs and symptoms suggesting the development of blood disorders, such as persistent fever, bruising, bleeding, paleness

recommended in association with methotrexate.

The symptoms described above may be signs of the following side effects, which have been observed
with Humira.

Very common(may affect more than 1 in 10 people)

reactions at the injection site (including pain, swelling, redness or itching)
respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia)
headache
abdominal pain
nausea and vomiting
skin rash
musculoskeletal pain

Common(may affect up to 1 in 10 people)

serious infections (including sepsis and influenza)
intestinal infections (including gastroenteritis)
skin infections (including cellulitis and herpes zoster infection)
ear infections
oral infections (including dental infections and herpes simplex)
reproductive system infections
urinary tract infections
fungal infections
infections of the joints
benign tumors
skin cancer
allergic reactions (including seasonal allergies)
dehydration
mood changes (including depression)
anxiety
sleep disorders
sensory disturbances such as tingling, pricking or numbness
migraine
nerve root compression (including lower back pain and leg pain)
visual disturbances
eye inflammation
eyelid inflammation and eye swelling
dizziness (feeling faint or lightheaded)
feeling of a fast heartbeat
high blood pressure
hot flushes
bruise (blood collection outside of blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
indigestion (heartburn, bloating, stomach upset)
acid reflux
dry eye syndrome (including dry eyes and dry mouth)
itching
itchy skin rash
contusion
skin inflammation (such as eczema)
nail breakage of the fingers and toes
increased sweating
hair loss
onset or worsening of psoriasis
muscle spasms
blood in urine
kidney problems
chest pain
edema (swelling)
fever
low platelet count in the blood, which increases the risk of bleeding or bruising
difficulty healing wounds

Uncommon(may affect up to 1 in 100 people)

opportunistic infections (which include tuberculosis and other infections that occur when the immune defenses are reduced)
neurological infections (including viral meningitis)
eye infections
bacterial infections
diverticulitis (inflammation and infection of the large intestine)
tumors
tumors of the lymphatic system
melanoma
immune system disorders that can affect the lungs, skin and lymph nodes (which most commonly present as sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor
neuropathy (nerve damage)
stroke
hearing loss, ringing in the ears
irregular heartbeat such as palpitations
heart problems that can cause shortness of breath or swelling of the ankles
acute myocardial infarction (heart attack)
formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel
lung disease causing shortness of breath (including inflammation)
pulmonary embolism (blockage of a pulmonary artery)
pleural effusion (abnormal collection of fluid in the pleural space)
inflammation of the pancreas causing severe pain in the abdomen and back
difficulty swallowing
facial edema (swelling of the face)
inflammation of the gallbladder, gallstones
fatty liver
night sweats
scarring
abnormal muscle breakdown
systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints and other organs)
interrupted sleep
impotence
inflammations

Rare(may affect up to 1 in 1,000 people)

leukemia (a cancer that affects the blood and bone marrow)
severe allergic reaction with shock
multiple sclerosis
neurological disorders (such as optic nerve inflammation and Guillain-Barré syndrome, which can cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
cardiac arrest
pulmonary fibrosis (scarring of the lungs)
intestinal perforation (hole in the intestine)
hepatitis
reactivation of hepatitis B
autoimmune hepatitis (liver inflammation caused by your own immune system);
cutaneous vasculitis (inflammation of the blood vessels in the skin)
Stevens-Johnson syndrome (early symptoms include feeling unwell, fever, headache and rash)
facial edema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome
angioedema (localized swelling of the skin)
lichenoid skin reaction (itchy, reddish-purple skin rash)

Not known(frequency cannot be estimated from available data)

T-cell hepatic-splenic lymphoma (a rare blood cancer that is often fatal)
Merkel cell carcinoma (a type of skin cancer)
Kaposi's sarcoma, a rare cancer associated with human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (which manifests as a skin rash accompanied by muscle weakness)
Weight gain (weight gain has been low for most patients)

Some of the side effects observed with Humira may be asymptomatic and can only be
detected through blood tests.
These include:

Very common(may affect more than 1 in 10 people)

low white blood cell count
low red blood cell count
increased lipids in the blood
increased liver enzymes

Common(may affect up to 1 in 10 people)

increased white blood cell count
decreased platelet count
increased uric acid in the blood
altered sodium in the blood
decreased calcium in the blood
decreased phosphorus in the blood
increased sugar in the blood
increased lactate dehydrogenase in the blood
presence of autoantibodies in the blood
decreased potassium in the blood

Uncommon(may affect up to 1 in 100 people)

high levels of bilirubin in the blood (liver blood test)

Rare(may affect up to 1 in 1,000 people)

low white blood cell, red blood cell and platelet counts

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store Humira

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/blister/box after the
word Exp.
Store in a refrigerator (2  C – 8  C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled pen can be stored
at room temperature (up to 25°C) for a maximum period of 14 days – ensure the
medicine is protected from light. Once it has been removed from the refrigerator to be stored at room
temperature, the pen must be used within 14 days or discarded, even if it is placed back in the
refrigerator.
You must record the date when the pen is removed from the refrigerator for the first time and the date after which the
pen must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor or pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humira contains
The active ingredient is adalimumab.
The excipients are mannitol, polysorbate 80 and water for injections.

Description of the appearance of Humira pre-filled pen and contents of the pack
Humira 80 mg solution for injection in a pre-filled pen is supplied as a sterile solution of 80 mg of
adalimumab dissolved in 0.8 ml of solution.
The Humira pre-filled pen is a single-use pen, coloured grey and purple, containing a glass
syringe in which Humira is present. The pen is equipped with two caps – one grey marked with the
number ‘1’ and the other purple marked with the number ‘2’. On each side of the pen there is a
window through which the Humira solution present inside the
syringe can be glimpsed.
The Humira pre-filled pen is available in packs containing:

1 pre-filled pen for use by patients with 2 alcohol swabs (1 extra)
3 pre-filled pens for use by patients with 4 alcohol swabs (1 extra)

Not all pack sizes may be marketed.
Humira may be available in vial, pre-filled syringe and/or pre-filled pen.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 21220174

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

Polska
AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

Hrvatska
AbbVie d.o.o.
Tel + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/ .

large characters> or
holder.

7. Humira Injection

The following instructions explain how to perform a subcutaneous self-injection of Humira using the pre-filled pen. First, read the instructions carefully and follow them step by step.
You will receive instructions from your doctor, nurse, or pharmacist on the self-administration technique.
Do not proceed with the injection on your own until you are sure you understand how to prepare and perform the injection.
After adequate instruction, the injection can be performed by you or by other people, such as a family member or friend.
Use each pre-filled pen exclusively for one injection only.

Humira Pre-filled Pen
Grey cap 1 White guard
covering the needleWhite arrowPurple cap 2

Injection pen with separate components highlighted by numbered arrows from 1 to 4 in metallic grey

Needle Window for inspection Purple activation button
Do not use the pre-filled pen and contact your doctor or pharmacist if

the solution appears cloudy, has changed color, or contains flocculi and particles
the expiry date (Exp.) has been exceeded
the solution has been frozen or exposed to direct sunlight
the pre-filled pen has been dropped or damaged

Do notremove the grey cap and the purple cap while Humira reaches room temperature
Do notheat Humira in any other way. For example, do notheat Humira in the microwave or in hot water STEP 2

Pen
Check the expiry date (Exp.). Do notuse the pre-
filled pen if the expiry date has been exceeded.
Arrange the following items on a flat and clean surface

Prefilled pen with protected needle, alcohol wipe and instructions d

1 single-use pre-filled pen
1 alcohol swab

Wash and dry your hands.

Swab
STEP 3
Choose an injection site:

Injection areas

On the front of the thigh or
On the abdomen (stomach) at least 5 cm away from the navel
At least 3 centimeters away from the last injection site chosen

Clean the injection site thoroughly with circular movements using the alcohol swab.

Person with medical patches applied to abdomen and knees, detailed close-up of hand applying a patch

Do notinject through clothing
Do notinject on damaged, bruised, reddened, hardened skin, with scars, stretch marks, or in areas with plaque psoriasis

Injection areas
STEP 4
Hold the pre-filled pen with the grey cap (1) facing
upwards.
Check through the inspection window.

Injection pen in hand with magnification of the cartridge release mechanism and numerical indication on the body

It is normal to notice one or more bubbles in the window
Make sure the solution is clear and colorless
Do notuse the pre-filled pen if the solution appears cloudy or contains particles
Do notuse if the pre-filled pen has been dropped or damaged

STEP 5
Cap 1
Remove the grey cap (1). Throw away the cap. Do notput
the cap back on.

Verify that the black protection covering the needle of the syringe has been removed together with the cap
It is normal for a few small drops of liquid to come out of the needle

Remove the purple cap (2). Throw away the cap. Do notput the
cap back on.
The pre-filled pen is now ready for use.
Rotate the pre-filled pen so that the white arrow
is facing the injection site.

Disassembled injectable pen with arrows indicating the detachment of the protective cap and of

Cap 2
STEP 6
With the other hand, pinch the skin at the injection site to
create a raised area and hold it firmly until the
injection is complete.
Position the white arrow towards the injection site (thigh or
abdomen).
Position the white guard covering the needle at a right angle

(90˚ angle)to the injection site.

Hand holding an injection pen with needle inserted into the skin at 90 degrees with angular indication and detailed enlargement

Hold the pre-filled pen so that you can see the
inspection window.

Do notpress the purple activation button until you are
ready to perform the injection.

STEP 7
15 Seconds
Press the pre-filled pen firmlyagainst the injection
site before starting the injection.

Continue to hold downto prevent the pre-filled
pen from moving away from the skin during the injection.

Pressthe purple activation button and count slowly to

15seconds.

Hand holding an insulin pen with needle inserted into the skin, arrow indicates the direction and detailed enlargement

A strong “click”will indicate the start of the injection
Continue to holdthe pre-filled pen firmly against the injection site until the injection is complete.

The injection will be complete when the yellow indicator has
stopped moving.

STEP 8
Once the injection is complete, slowly withdraw the
pre-filled pen from the skin. The white guard covering
the needle will cover the tip of the needle.

Hand holding a self-administered injection device pressed against the thigh with a black arrow indicating the direction

The presence of a small amount of liquid at the injection site is normal.

If there is more than a few drops at the injection site, contact your doctor, nurse, or pharmacist.
After completing the injection, apply a cotton ball
or gauze to the skin at the injection site.

Do notrub
A slight bleeding at the injection site is normal STEP 9

Dispose of the used pre-filled pen in a special container following the instructions of your doctor,
nurse, or pharmacist.

Do notrecycle or dispose of the pre-filled pen in household waste
Alwayskeep the pre-filled pen and the special container out of the sight and reach of children

The caps, alcohol swabs, cotton ball or gauze, blister and packaging
can be disposed of in household waste.

Страна регистрации
Италия
Форма выпуска
Injectable solution, 40MG/0.8ML
Код АТХ
L04AB04
Действующее вещество
Адалимумаб
Отпускается по рецепту
Да
Производитель
ABBVIE DEUTSCHLAND GMBH & CO. KG
Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
Аналоги UMIRA
AMJEVITA
Форма выпуска: Injectable solution, 20 MG
Действующее вещество: Адалимумаб
Производитель: AMGEN EUROPE B.V.
Отпускается по рецепту
EFIYA
Форма выпуска: Injectable solution, 40 MG
Действующее вещество: Адалимумаб
Производитель: SANDOZ GMBH
Отпускается по рецепту
UKYNDRA
Форма выпуска: Injectable solution, 40 mg
Действующее вещество: Адалимумаб
Производитель: STADA ARZNEIMITTEL AG
Отпускается по рецепту

Аналоги UMIRA в других странах

Лекарства с тем же действующим веществом, доступные в других странах.

Аналог UMIRA в Испания

ЮФЛИМА 80 мг РАСТВОР ДЛЯ ИНЪЕКЦИЙ В ПРЕДНАПОЛНЕННОМ ШПРИЦЕ

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 80 мг

Действующее вещество: Адалимумаб

Производитель: Celltrion Healthcare Hungary Kft.

Отпускается по рецепту

ЮФЛИМА 40 мг Раствор для инъекций в предварительно заполненном шприце

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 40 мг

Действующее вещество: Адалимумаб

Производитель: Celltrion Healthcare Hungary Kft.

Отпускается по рецепту

ИМРАЛДИ 40 мг РАСТВОР ДЛЯ ИНЪЕКЦИЙ В ПРЕДНАПОЛНЕННОМ ШПРИЦ-РУЧКЕ

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 40 мг

Действующее вещество: Адалимумаб

Производитель: Samsung Bioepis Nl B.V.

Отпускается по рецепту

ИМРАЛДИ 40 мг Раствор для инъекций в предварительно заполненном шприце

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 40 мг

Действующее вещество: Адалимумаб

Производитель: Samsung Bioepis Nl B.V.

Отпускается по рецепту

ХИРИМОЗ 20 мг РАСТВОР ДЛЯ ИНЪЕКЦИЙ В ПРЕДНАПОЛНЕННОМ ШПРИЦЕ

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 20 мг

Действующее вещество: Адалимумаб

Производитель: Sandoz Gmbh

Отпускается по рецепту

ХУМИРА 40 мг РАСТВОР ДЛЯ ИНЪЕКЦИЙ В ПРЕДНАПОЛНЕННОМ ШПРИЦЕ-РУЧКЕ

Форма выпуска: ИНЪЕКЦИОННЫЙ РАСТВОР, 40 мг

Действующее вещество: Адалимумаб

Производитель: Abbvie Deutschland Gmbh & Co. Kg

Отпускается по рецепту

Аналог UMIRA в Украина

АБРІЛАДА

Форма выпуска: раствор, 40 мг/0,8 мл

Действующее вещество: Адалимумаб

Производитель: Pfajzer Servis Kompani BV (vipusk serii)

Отпускается по рецепту

ХУМІРА

Форма выпуска: раствор, 40 мг/0,4 мл

Действующее вещество: Адалимумаб

Производитель: Vetter Farma-Fertigung GmbH i Ko. KG

Отпускается по рецепту

ХУМІРА

Форма выпуска: раствор, 20 мг/0,2 мл

Действующее вещество: Адалимумаб

Производитель: Vetter Farma-Fertigung GmbH i Ko. KG

Отпускается по рецепту

ХАДЛІМА

Форма выпуска: раствор, 40 мг/0,8 мл

Действующее вещество: Адалимумаб

Производитель: Katalent Bel'dzium

Отпускается по рецепту

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5.0(2)

Наталья Бессолицына

Ревматология26 лет опыта

С какими симптомами и диагнозами можно обратиться:

Боли в суставах — острая, хроническая, рецидивирующая боль.
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Артрозы: остеоартроз, коксартроз, гонартроз, узелковый полиостеоартроз.
Плечелопаточный периартрит и спондилоартриты.
Хронические воспалительные заболевания позвоночника — болезнь Бехтерева.
Системные аутоиммунные заболевания: системная красная волчанка, склеродермия, системные васкулиты.
Остеопороз и нарушение плотности костей.

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Часто задаваемые вопросы

Требуется ли рецепт для UMIRA?

UMIRA требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.

Какое действующее вещество у UMIRA?

Действующее вещество UMIRA — Адалимумаб. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.

Кто производит UMIRA?

UMIRA производится компанией ABBVIE DEUTSCHLAND GMBH & CO. KG. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.

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Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения UMIRA с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.

Как купить UMIRA в Польше?

Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.

Вы можете купить UMIRA в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.

Чтобы получить рецепт, вы можете воспользоваться Oladoctor:

Какие есть альтернативы UMIRA?

Другие лекарства с тем же действующим веществом (Адалимумаб) включают AMJEVITA, EFIYA, UKYNDRA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.

HUMIRA 40 mg /0.8 Мл Инъекционный Раствор

Рассмотрение рецепта онлайн

Поговорите с врачом об этом лекарстве

Наталья Бессолицына

Инструкция по применению UMIRA

Humira 20 mg solution for injection in pre-filled syringe

1. What is Humira and what is it used for

2. What you need to know before your child uses Humira

3. How to use Humira

4. Possible side effects

5. How to store Humira

6. Contents of the pack and other information

7. Humira Injection

Humira 40 mg/0.8 ml injectable solution

1. What is Humira and what is it used for

2. What you need to know before your child uses Humira

3. Come usare Humira

4. Possible side effects

5. How to store Humira

6. Contents of the pack and other information

Не уверены, подходит ли вам это лекарство?

Humira 40 mg injectable solution in pre-filled syringe

1. What is Humira and what is it used for

2. What you need to know before using Humira

3. Come usare Humira

4. Possible side effects

5. How to store Humira

6. Contents of the pack and other information

Humira 40 mg solution for injection in pre-filled pen

1. What is Humira and what is it used for

2. What you need to know before using Humira

3. How to use Humira

4. Possible side effects

5. How to store Humira

6. Contents of the pack and other information

Уже начали прием и появились вопросы?

Humira 40 mg injectable solution in pre-filled syringe

1. What is Humira and what is it used for

Humira may slow down the progression of joint damage caused by the disease

2. What you need to know before using Humira

3. How to use Humira

4. Possible side effects

5. How to store Humira

6. Contents of the pack and other information

7. Humira Injection

Humira 40 mg solution for injection in pre-filled pen

1. What is Humira and what is it used for

2. What you need to know before using Humira

3. How to use Humira

4. Possible side effects

5. How to store Humira

6. Contents of the pack and other information

7. Humira Injection

Humira 80 mg injectable solution in pre-filled syringe

1. What is Humira and what is it used for?

2. What you need to know before using Humira

3. How to use Humira

4. Possible side effects

5. How to store Humira

6. Contents of the pack and other information

7. Humira Injection

Humira 80 mg solution for injection in pre-filled pen

1. What is Humira and what is it used for

2. What you need to know before using Humira

3. How to use Humira

4. Possible side effects

5. How to store Humira

6. Contents of the pack and other information

7. Humira Injection

Аналоги UMIRA в других странах

Аналог UMIRA в Испания

Аналог UMIRA в Украина

Врачи онлайн по UMIRA

Наталья Бессолицына

Получите рецепт на UMIRA онлайн

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