YUFLYMA 40 mg 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

zł238

Больше времени

Материал предназначен для общего ознакомления. Для индивидуальных рекомендаций обратитесь к врачу. При тяжелых или быстро ухудшающихся симптомах обратитесь за неотложной медицинской помощью.

Инструкция по применению YUFLYMA

Содержание инструкции

Yuflyma 40 mg injectable solution in pre-filled syringe
Yuflyma 40 mg injectable solution in pre-filled pen
Yuflyma 80 mg injectable solution in pre-filled syringe
Yuflyma 80 mg injectable solution in pre-filled pen
Yuflyma 20 mg injectable solution in pre-filled syringe

Yuflyma 40 mg injectable solution in pre-filled syringe

adalimumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects experienced
during the use of this medicine. See the end of section 4 for information on how
to report adverse effects.

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 also provide you with a Patient Reminder Card, which contains important safety information that you should know before and during treatment with Yuflyma. Keep the Patient Reminder Cardwith you during your treatment and for 4 months after the last Yuflyma injection.
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 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Yuflyma and what is it used for

Yuflyma contains the active ingredient adalimumab, a medicine that acts on the immune system (the
body's defense).
Yuflyma is indicated for the treatment of the following inflammatory diseases:

Rheumatoid arthritis
Juvenile idiopathic polyarticular 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

The active ingredient of Yuflyma, adalimumab, is a human monoclonal antibody. Monoclonal antibodies
are proteins that bind to a specific target in the body.
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, Yuflyma reduces the inflammatory process of these
diseases.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
Yuflyma is used for the treatment of moderate to severe rheumatoid arthritis in adults. You may
first receive other disease-modifying drugs, such as methotrexate. If you do not respond
adequately to these drugs, Yuflyma will be administered to you.
Yuflyma can also be used for the treatment of severe, active and progressive rheumatoid arthritis, without
previous treatment with methotrexate.
Yuflyma may slow the progression of joint damage caused by the inflammatory disease and
may help you move more freely.
The doctor will decide whether Yuflyma should be used with methotrexate or alone.

Juvenile idiopathic polyarticular arthritis
Juvenile idiopathic polyarticular arthritis is an inflammatory disease of the joints.
Yuflyma is used for the treatment of juvenile idiopathic polyarticular arthritis in patients from 2 years
of age. You may first receive other disease-modifying drugs, such as methotrexate. If you do not
respond adequately to these drugs, Yuflyma will be administered to you.
The doctor will decide whether Yuflyma should be used with methotrexate or alone.

Enthesitis-related arthritis
Enthesitis-related arthritis is an inflammatory disease of the joints and the areas where the
tendons attach to the bones.
Yuflyma is used to treat enthesitis-related arthritis in patients aged 6 years or older. You
may first receive other disease-modifying drugs, such as methotrexate. If you do not respond
adequately to these drugs, Yuflyma will be administered to you.

Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
are inflammatory diseases of the spine.
Yuflyma is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic
evidence of ankylosing spondylitis of severe grade in adults. Other medications may be taken initially. If you do not respond adequately to these drugs, Yuflyma will be administered to you.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints usually associated with psoriasis.
Yuflyma is used to treat psoriatic arthritis in adults. Yuflyma may slow the damage to the
joints caused by the disease and may help you move more freely. Other medications may be taken initially. If you do not respond adequately to these drugs, Yuflyma will be administered to you.

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.
Yuflyma 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 therapy and phototherapies have not worked optimally 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. More
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.
Yuflyma is used to treat

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

Yuflyma may reduce the number of nodules and abscesses caused by the disease and the pain that is often
associated with the disease. Other medications may be taken initially. If you do not respond
adequately to these drugs, Yuflyma will be administered to you.

Crohn’s disease
Crohn’s disease is an inflammatory disease of the digestive tract. Yuflyma 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 medications may be taken initially. If you do not respond adequately to these drugs, you will
be administered Yuflyma.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large intestine.
Yuflyma 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 you do not respond adequately to these drugs, you
will be administered Yuflyma.

Non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye. Yuflyma is used
to treat

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). Yuflyma works by reducing
this inflammation.
Other medications may be taken initially. If you do not respond adequately to these drugs, you
will be administered Yuflyma.

2. What you need to know before using Yuflyma

Do not use Yuflyma:

if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
In the presence of 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.
In the presence of 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 Yuflyma.
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 Yuflyma 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 Yuflyma. If you have any doubts, contact your doctor.
You may be more likely to get infections during treatment with Yuflyma. 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 infection (sepsis)

In rare cases, these infections 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 tell you to stop Yuflyma 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 medical 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 Yuflyma. You and your doctor should pay particular attention to signs of infection during treatment with Yuflyma. 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 Yuflyma if you have active tuberculosis.
Because cases of tuberculosis have occurred in patients treated with Yuflyma, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Yuflyma. 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 hepatitis B virus infection, 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 Yuflyma may cause the virus to reactivate.
In some rare cases, especially if the patient is receiving 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 Yuflyma. Your doctor may advise you to temporarily stop Yuflyma. 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 Yuflyma. 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 Yuflyma.
Consult your doctor before getting vaccinated.
It is recommended, if possible, to have children vaccinated for their age before starting treatment with Yuflyma.
If you have taken Yuflyma during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose of Yuflyma received during pregnancy. It is important that you tell your pediatrician or other healthcare provider about your use of Yuflyma 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 receiving concomitant treatment with Yuflyma, your doctor should carefully assess and monitor your heart condition. It is important to tell your doctor if you have had or have had serious heart problems in the past. 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. Your doctor will decide if Yuflyma 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 a persistent fever, bruising or easy bleeding, or paleness, see your doctor immediately.

Cancer

Very rarely, some types of cancer have occurred in patients, both children and adults, treated with Yuflyma 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 you are taking Yuflyma, the risk of developing lymphomas, leukemia, or other cancers may increase. In rare circumstances, a rare and serious type of lymphoma has been observed in patients treated with Yuflyma. Some of these patients were also taking azathioprine or 6-mercaptopurine.
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Yuflyma.
Cases of non-melanoma skin cancer have been observed in patients taking Yuflyma.
If new skin lesions appear during or after therapy, or if the appearance of existing lesions changes, tell your doctor.
There have been cases of cancer, 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.

Autoimmune disease

Rarely, treatment with Yuflyma can lead to the development of a lupus-like syndrome. 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 already had all vaccinations before using Yuflyma.

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

anakinra
abatacept.

Yuflyma can be taken with:

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

If you have any doubts, ask your doctor.

Pregnancy and breastfeeding

You should consider using adequate contraception to prevent pregnancy and continue it for at least 5 months after the last therapy with Yuflyma.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice about taking this medicine.
Yuflyma 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 Yuflyma during pregnancy, compared to mothers who had the same condition but did not receive Yuflyma.
Yuflyma can be used during breastfeeding.
If you take Yuflyma 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 Yuflyma during pregnancy before the baby receives any type of vaccination. For further information on vaccinations, see the section “Warnings and precautions”.

Driving and using machines
Yuflyma may have a mild effect on your ability to drive, ride a bicycle or use machines.
After taking Yuflyma, you may experience visual disturbances and a feeling that the environment in
which you are located is rotating.

YUFLYMA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 mL dose, i.e. essentially
“sodium-free”.

3. How to use Yuflyma

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 Yuflyma in each approved indication are listed in the following table. The
doctor may prescribe a different concentration of Yuflyma if you need a different dose.

a 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?	m Notes
Adults	40 mg every other week l e d	In rheumatoid arthritis r continue to take the a methotrexate during the treatment with Yuflyma. If the F doctor decides that methotrexate is not appropriate, Yuflyma can be administered alone. If you have rheumatoid arthritis and are not taking methotrexate in association with Yuflyma, your doctor may decide to prescribe 40 mg of Yuflyma every week or 80 mg every other week.

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

Enthesitis-related arthritis
a Age or body weight	How much should be taken and how often?	Notes
i z Children, adolescents and adults from 6 years of age with weight equal to or greater than 30 kg	40 mg every other week	Not applicable
n Children and adolescents from 6 years of age and with weight between 15 kg and less than 30 kg	20 mg every other week	Not applicable

g Plaque psoriasis
A Age or body weight	How much should be taken and how often?	Notes
Adults	First dose of 80 mg (two injections of 40 mg on one day), followed by 40 mg a	In case of inadequate response the doctor may increase the dosage to 40 mg every

	week or 80 mg every other week, starting from one week after the first dose.	o week or 80 mg every other week.
Children and adolescents from 4 to 17 years of age with weight equal to or greater than 30 kg	First dose of 40 mg, followed by 40 mg one week later. Subsequently, the usual dose is 40 mg every other week.	c Not applicable 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

l Hidradenitis suppurativa
Age or body weight	e How much should be taken and how often?	Notes
Adults	d First dose of 160 mg (four injections of 40 mg on one day or two injections of 40 mg per day, a for two consecutive days), followed by a dose of 80 mg n (two injections of 40 mg on one day) two weeks later. a After another two weeks, continue with a dose of 40 i mg every week or 80 mg every two weeks, as prescribed l by the doctor.	It is recommended to use every day an antiseptic cleansing solution on the affected areas.
Adolescents from 12 to 17 years of age with weight equal to or greater than 30 kg a i	a First dose of 80 mg (two injections of 40 mg on one day), t followed by 40 mg every other week, starting from the following week.	In case of inadequate response to Yuflyma 40 mg 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 every day an antiseptic cleansing solution on the affected areas.

z Crohn’s disease
n Age or body weight	How much should be taken and how often?	Notes
e Children, adolescents and adults from 6 years of age with weight g equal to or greater than 40 kg A	First dose of 80 mg (two injections of 40 mg on one day), followed by 40 mg two weeks later. If a faster response is needed, the doctor may prescribe an initial dose of 160 mg (four	The doctor may increase the dose to 40 mg every week or 80 mg every other week.

	injections of 40 mg on one day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (two injections of 40 mg on one day) after two weeks. Subsequently, the usual dose is 40 mg every other week.	m a c o
Children and adolescents aged between 6 and 17 years and with weight less than 40 kg	An initial dose of 40 mg followed by 20 mg after two weeks. If a faster response is needed, the doctor may prescribe an initial dose of 80 mg (two injections l of 40 mg on one day), followed e by 40 mg after two weeks. d Subsequently, the usual dose is 20 mg every other week.	The doctor may increase the frequency of the dose to 20 mg every week. F

a Ulcerative colitis
Age or body weight	n How much should be taken and how often?	Notes
Adults	a First dose of 160 mg (four injections of 40 mg on one day or i two injections of 40 mg per day for two consecutive days), l followed by 80 mg (two injections a of 40 mg on one day) after two weeks. t I 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.
Children and adolescents from 6 years of age and with weight less than 40 kg i z	An initial dose of 80 mg (two injections of 40 mg on one day), followed by 40 mg (one injection of 40 mg) after two weeks. Subsequently, the usual dose is 40 mg every other week.	Yuflyma should continue to be taken at the usual dose, even after turning 18 years of age.
n Children and adolescents from 6 years of age and with weight equal to or greater than 40 kg g A	An initial dose of 160 mg (four injections of 40 mg on one day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (two injections of 40 mg on one day) after two weeks. Subsequently, the usual dose is 80 mg every other week.	Yuflyma should continue to be taken at the usual dose, even after turning 18 years of age.

Uveitis not infectious
Age or body weight	How much should be taken and how often?	o Notes
Adults	First dose of 80 mg (two injections of 40 mg on one day), followed by 40 mg every other week starting from one week after the first dose.	c Corticosteroids or other drugs that affect the immune system may be continued during treatment with Yuflyma. Yuflyma can also be administered as monotherapy.
Children and adolescents from 2 years of age and with weight less than 30 kg	20 mg every other week l	r The doctor may prescribe a initial dose of 40 mg to be administered one week before starting the usual dose of 20 mg every other week. The use of Yuflyma is recommended in association with methotrexate.
Children and adolescents from 2 years of age with weight of at least 30 kg	e 40 mg every other week d a	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 Yuflyma is recommended in association with methotrexate.

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

Detailed instructions on how to administer Yuflyma are described in section 7 “Instructions for
use”.
If you use more Yuflyma than you should
If you accidentally inject Yuflyma 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 Yuflyma
If you forget to give an injection, you should inject the next dose of Yuflyma as soon as you remember.
Then resume the dose regularly according to the established dosage schedule.

If you stop treatment with Yuflyma
The decision to stop using Yuflyma must be discussed with your doctor. Symptoms may
return if you stop using Yuflyma.
If you have any doubts about the use of 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. However, some can be serious and require treatment. Side effects may occur up to 4 months
after the last injection of Yuflyma.

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
feeling weak/tired
cough
tingling
numbness
double vision
weakness of 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
Yuflyma.

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 cold sores)
reproductive system infections
urinary tract infection
fungal infections
joint infections
benign tumors
skin cancer
allergic reactions (including seasonal allergies)
dehydration
mood changes (including depression)
anxiety
difficulty sleeping
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 dizzy or spinning)
feeling of a fast heartbeat
high blood pressure
hot flushes
bruise (blood accumulation outside blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heartburn)
acid reflux disorder
dry syndrome (including dry eyes and dry mouth)
itching
itchy skin rash
bruising
skin inflammation (such as eczema)
breaking of fingernails and toenails
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
impaired wound healing

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)
cancer
lymphatic system cancer
melanoma
immune system disorders that can affect lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (nervous system disorder)
stroke
hearing loss, ringing
feeling of irregular heartbeat such as palpitations
heart problems that can cause shortness of breath or swelling at the ankles
heart attack
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 lung artery)
pleural effusion (abnormal accumulation of fluid in the pleural space)
pancreatitis (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 skin, heart, lung, joint and other organ inflammation)
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 lung)
intestinal perforation (hole in the intestine)
hepatitis
hepatitis B reactivation
autoimmune hepatitis (liver inflammation caused by your own immune system)
cutaneous vasculitis (inflammation of the skin blood vessels)
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 skin swelling)
lichenoid skin reaction (itchy reddish-purple 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 associated with human herpes virus 8 infection. Kaposi's sarcoma most commonly appears as 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 Yuflyma 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
reduced platelets in the blood
increased uric acid in the blood
altered sodium in the blood
reduced calcium in the blood
reduced phosphate 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 (blood test related to the liver)

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

5. How to store Yuflyma

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/outer packaging after the
word Expiry..
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe with the needle safety device in the outer packaging to
protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled syringe with a safety device for the needle of Yuflyma can be stored at room temperature (up to 25°C) for a maximum period of 31 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 31 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. Package contents and other information

What Yuflyma contains
The active ingredient is adalimumab.
The other ingredients are acetic acid, sodium acetate trihydrate, glycine, polysorbate 80, and water for
injections.

Description of the appearance of Yuflyma pre-filled syringe with safety device for the needle and
package contents
Yuflyma 40 mg injectable solution in a pre-filled syringe with a safety device for the needle is supplied
as a sterile solution of 40 mg of adalimumab dissolved in 0.4 mL of solution.
Yuflyma pre-filled syringe consists of a solution of adalimumab contained in a glass syringe.
The pack of 1 pre-filled syringe is supplied with 2 alcohol swabs (1 spare). In
packs of 2, 4 and 6 pre-filled syringes, each pre-filled syringe is supplied with 1 alcohol swab.
Yuflyma pre-filled syringe is a solution based on adalimumab contained in a glass syringe with
safety device for the needle. The pack of 1 pre-filled syringe with safety device for
the needle is supplied with 2 alcohol swabs (1 spare). In packs of 2, 4 and 6 pre-
filled syringes with safety device for the needle, each pre-filled syringe is supplied with 1 alcohol swab.
Not all pack sizes may be marketed.
Yuflyma may be available as a pre-filled syringe and/or pre-filled pen.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Millmount Healthcare Ltd.
Block 7
City North Business Campus
Stamullen, Co. Meath K32 YD60
Ireland
Nuvisan GmbH
Wegenerstraße 13,
89231 Neu Ulm,
Germany
Nuvisan France SARL
2400, Route des Colles,
06410, Biot,
France
Midas Pharma GmbH
Rheinstr. 49,
55218 Ingelheim,
Germany
KYMOS S.L.
Ronda Can Fatjó, 7B.
08290 Cerdanyola del Vallès,
Barcelona,
Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Celltrion Healthcare Belgium BVBA
Tél/Tel: + 32 1528 7418

Lietuva
Celltrion Healthcare Hungary Kft.
Tel.: +36 1 231 0493

България
Celltrion Healthcare Hungary Kft.
Teл.: +36 1 231 0493

Luxembourg/Luxemburg
Celltrion Healthcare Belgium BVBA
Tél/Tel: + 32 1528 7418

Česká republika
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

Magyarország
Celltrion Healthcare Hungary Kft.
Tel.: +36 1 231 0493

Danmark
Celltrion Healthcare Hungary Kft.
Tlf: +36 1 231 0493

Malta
Mint Health Ltd.
Tel: +356 2093 9800

Deutschland
Celltrion Healthcare Deutschland GmbH
Tél.: +49 (0)30 346494150
[email protected]

Nederland
Celltrion Healthcare Netherlands B.V.
Tel: + 31 20 888 7300

Eesti
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

Norge
Celltrion Healthcare Hungary Kft.
Tlf: +36 1 231 0493

España
Kern Pharma, S.L.
Tel: +34 93 700 2525

Österreich
Astro-Pharma GmbH
Tel: +43 1 97 99 860

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30 210 8009111

Polska
Celltrion Healthcare Hungary Kft.
Tel.: +36 1 231 0493

France
Celltrion Healthcare France SAS
Tél.: +33 (0)1 71 25 27 00

Portugal
PharmaKERN Portugal - Produtos Farmacêuticos,
Sociedade Unipessoal, Lda.
Tel: +351 214 200 290

Hrvatska
Oktal Pharma d.o.o.
Tel: +385 1 6595 777

România
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

Ireland
Celltrion Healthcare Ireland Limited
Tel: +353 1 223 4026

Slovenija
OPH Oktal Pharma d.o.o.
Tel.: +386 1 519 29 22

Ísland
Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493

Slovenská republika
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

Italia
Celltrion Healthcare Italy S.r.l.
Tel: +39 02 47927040

Suomi/Finland
Celltrion Healthcare Finland Oy.
Puh/Tel: +358 29 170 7755

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741741

Sverige
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

United Kingdom (Northern Ireland)
Celltrion Healthcare Ireland Limited
Tel: +353 1 223 4026

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu

Latvija
Celltrion Healthcare Hungary Kft.
Tālr.: +36 1 231 0493

7. Instructions for Use

The following instructions explain how to perform a subcutaneous self-injection of Yuflyma 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-injection technique.
Do notproceed 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 other people, such as a family member or friend.
Use each pre-filled syringe exclusively for a single injection.

Yuflyma Prefilled Syringe

Prefilled syringes with medication, one before and one after

Do not use the pre-filled syringe if:

it is cracked or damaged.
the expiry date has been exceeded.
it has fallen onto a hard surface. Remove the needle cap only immediately before the injection. Keep Yuflyma out of the sightand reach of children.

1. Prepare the materials for the injection

a.Prepare a clean, flat surface, such as a table or shelf, in a well-lit area.
b.Remove 1 pre-filled syringe from the box stored in the refrigerator.

When removing the pre-filled syringe from the box, hold it by the body. Do nottouch the plunger.

c.Make sure you have the following materials:

Pre-filled syringe
alcohol-soaked swab Not included in the box:
cotton wool or gauze
adhesive bandage
sharps disposal container

2. Inspect the pre-filled syringe

a. Make sure you have the correct medicine (Yuflyma) and dosage.

b. Look at the pre-filled syringe and make sure it is not
cracked or damaged.

c. Check the expiration date on the label of the pre-filled syringe.

Do notuse the pre-filled syringe if:

it is cracked or damaged
the expiration date has passed.
it has fallen onto a hard surface.

Prefilled syringe with blue plunger and green protective cap, highlighted by a circle with expiration date indication

3. Inspect the medicine

a. Check the medicine to confirm that the liquid is clear, from colorless to light brown and free of particles.

Do notuse the pre-filled syringe if the liquid is: discolored (yellow or dark brown), cloudy, or contains particles.
You may see air bubbles in the liquid. This is normal.

Prefilled syringe with visible plunger and enlargement of the transparent cylinder with terminal rubber stopper

4. Wait 15-30 minutes

Clock showing 3:00 PM with the inscription 15-30 minutes and blue and green prefilled syringe on a gray background

15 - 30minutesto. Leave the pre-filled syringe at room temperature for 15-30 minutes so that it can warm up.

Donot heat the pre-filled syringe using heat sources such as hot water or microwave.

5. Choose an appropriate injection site

a.You can perform the injection:

Human body diagram with areas colored in blue and gray indicating injection sites for self-administration and for caregiver

on the front of the thigh
in the abdomen, except for the area within 5 cm around the navel
in the outer area of the upper arm (ONLY if you are a person assisting the patient).

Do notperform the injection in skin areas within 5 cm of your navel or in an area that is reddened, hardened, painful, damaged, bruised, or has scars.
If you have psoriasis, do notperform the injection on any raised, thickened, reddened, or scaly patches or on any skin lesions.
Do notperform the injection through clothing.

b.Rotate the injection site each time you administer an injection. Each new injection site must be at least 3 cm away from the previously used injection site.

6. Wash your hands.

a.Wash your hands with soap and water and dry them thoroughly.

7. Clean the injection site

Bent knee with hand applying an adhesive bandage on fair skin above the knee

a. Clean the injection site with a swab soaked
in alcohol, making a circular motion.

b.Allow the skin to dry before the injection.

Do notblow on the injection site or touch it again before performing the injection.

8. Remove the cap

Hand holding a pre-filled syringe with a blue needle and protective cap removed arrows indicate direction and detail of biological waste container

a. Remove the cap while holding the body of the pre-filled syringe with one hand. Gently pull the cap with the other hand.

Do notremove the cap until you are ready to administer the injection
Do nottouch the needle. This could result in a needle stick injury.
Do notreplace the cap on the pre-filled syringe. Immediately dispose of the cap in a sharps container.
It is normal to see a few drops of liquid

from the needle.

9. Insert the pre-filled syringe into the injection site

Hand holding a syringe tilted at 45 degrees while the

a.With one hand, gently pinch the skin to create a fold at the injection site.

b. Holding the pre-filled syringe by the body, insert
the needle completely into the skin fold at
a 45-degree angle with a quick motion,
as when throwing a dart.

10. Perform the injection

Subcutaneous injection with needle inserted into the skin of the arm and black arrow indicating the direction

a.Once the needle is inserted, release the pinched skin.
b.Slowly and completely push the plunger down to inject all the liquid and empty the syringe.

Do notchange the position of the pre-filled syringe once the injection has started.

11. Remove the pre-filled syringe from the injection site and

take care of the injection site

Hand holding a syringe with needle inserted into the skin, black arrow indicates the direction

a.Once the pre-filled syringe is emptied, remove it from the skin at the same angle you inserted it.
b.Treat the injection site by gently pressing on it, without rubbing, with a cotton ball or gauze and, if necessary, apply a bandage. Some bleeding may occur.

Do notreuse the pre-filled syringe.
Do nottouch the needle or cover it with the cap.
Do notrub the injection site.

12. Dispose of the pre-filled syringe

Do notreplace the cap on the pre-filled syringe.

Hand guiding a syringe with a needle towards a container for special waste with a black biohazard symbol on a white background

a.Throw the used pre-filled syringe into a special container for the disposal of sharp objects, as instructed by your doctor, pharmacist or nurse.
b.The alcohol swab and the packaging can be put in household waste.

Always keep the pre-filled syringe and the special sharps waste container out of sight and reach of children.

Yuflyma pre-filled syringe with safety device for the needle

Syringe with plunger, flange, inspection window and needle shown before and after

1. Prepare the materials for the injection

a.Prepare a clean, flat surface, such as a table or shelf, in a well-lit area.
b.Remove 1 pre-filled syringe from the box stored in the refrigerator.

When removing the pre-filled syringe from the box, hold it by the body. Do nottouch the plunger.

c.Make sure you have the following materials:

Pre-filled syringe
Alcohol-soaked swab

Not included in the box:

Cotton ball or gauze
Adhesive bandage
Sharps disposal container

Do not use the pre-filled syringe if:
it is cracked or damaged.
the expiration date has passed.
it has been dropped onto a hard surface.

a Remove the needle cap only immediately before the injection. Keep Yuflyma out of the sight
and reach of children.

2. Inspect the pre-filled syringe

a.Make sure you have the correct medicine (Yuflyma) and dosage
b.Look at the pre-filled syringe and make sure it is not cracked or damaged.

Auto-injector device with visible needle and magnification showing the cross-section of the internal mechanism

c.Check the expiration date on the label of the pre-filled syringe.

Do notuse the pre-filled syringe if:

it is cracked or damaged
the expiration date has passed.
it has fallen onto a hard surface.

3. Inspect the medication

a.Check the medication to confirm that the liquid is clear, from colorless to light brown, and free of particles.

Do notuse the pre-filled syringe if the liquid is: discolored (yellow or dark brown), cloudy, or contains particles.
You may see air bubbles in the liquid. This is normal.

Blue and green injection pen with enlargement of the

Figure C

4. Wait 15-30 minutes

a.Allow the pre-filled syringe to reach room temperature for 15-30 minutes so that it can warm up.

Do notheat the pre-filled syringe using heat sources such as hot water or a microwave.

Prefilled syringe with green safety mechanism and clock indicating 15-30 minutes waiting time

15 - 30minutes

5. Choose an appropriate injection site

a.You can perform the injection:

on the front of the thigh
in the abdomen, except for the area within 5 cm around the navel
in the outer area of the upper arm (ONLY if you are a person assisting the patient).

Do notperform the injection in skin areas within 5 cm

Human body diagram with areas colored in blue and gray indicating injection sites for self-administration and by a caregiver

from your navel or in an area that is red, hard,
painful, damaged, bruised, or where there are scars.

If you have psoriasis, do notperform the injection in any thickened, red or flaky patches or on any skin lesion.
Do notperform the injection through clothing.

b.Rotate the injection site each time you administer an injection. Each new injection site must be at least 3 cm away from the previously used injection site.

Figure E

6. Wash your hands.

a.Wash your hands with soap and water and dry them thoroughly.

7. Clean the injection site

a.Clean the injection site with a swab soaked in alcohol, making a circular motion.
b.Allow the skin to dry before the injection.

Do not blow on the injection site or touch it again before performing the injection.

Bent knee with hand applying an adhesive bandage to fair skin on the lateral area

8. Remove the cap

a. Remove the cap while holding the body of the pre-filled syringe with one hand. Gently pull the cap with the other hand.

Do notremove the cap until you are ready to administer the injection
Do nottouch the needle. This could result in a needle stick injury.
Do notreplace the cap on the pre-filled syringe. Immediately dispose of the cap in a sharps container.
It is normal to see a few drops of liquid exiting the needle.

Hand assembling an injection device with a protected needle and green cylinder, arrows indicate movement and detail of disposal in a biohazard container

9. Insert the pre-filled syringe into the site

of injection

a.With one hand, gently pinch the skin to create a fold at the injection site.
b.Holding the pre-filled syringe by the body, insert

Hand holding a pre-filled syringe with needle inserted into the arm at 45 degrees indicated by an angle

completely the needle into the skin fold
at an angle of 45 degrees, using a
quick movement, as when throwing a
dart.

10. Perform the injection

a.Once the needle is inserted, release the pinched skin.
b.Slowly and completely push the plunger down until all the liquid is injected and the syringe is empty.

Do notchange the position of the pre-filled syringe once the injection has started.

Hand holding a prefilled syringe with needle inserted into the skin, black arrow indicates the direction of

11. Remove the pre-filled syringe from the site

of injection andtake care of the injection site

a.When the pre-filled syringe is empty, slowly lift your thumb off the plunger until the needle is completely covered by the needle safety device.
b.Treat the injection site by gently pressing, without rubbing, a cotton ball or gauze on the site and, if necessary, applying an adhesive bandage. Bleeding may occur.

Do notreuse the pre-filled syringe.
Do not rub the injection site

Prefilled syringe with needle inserted into the skin, black arrow indicates the direction of injection, hand supporting the device

12. Dispose of the pre-filled syringe

a.Immediately discard the used pre-filled syringe in a suitable container for the disposal of sharp objects as indicated by your doctor, nurse or pharmacist.
b.The alcohol swab and the packaging can be put in household waste.

Always keep the pre-filled syringe and the special container for the disposal of sharp objects out of sight and reach of children.

Hand placing a used syringe in a special waste container with a visible biological hazard symbol

Yuflyma 40 mg injectable solution in pre-filled pen

pre-filled
adalimumab

Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects you experience
while taking this medicine. See the end of section 4 for information on how to
report adverse effects.

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 also provide you with a Patient Reminder Card, which contains important safety information that you should know before and during treatment with Yuflyma. Keep the Patient Reminder Cardwith you during your treatment and for 4 months after the last Yuflyma injection.
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 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Yuflyma and what is it used for

Yuflyma contains the active ingredient adalimumab, a medicine that acts on the immune system (the
body's defense).
Yuflyma is indicated for the treatment of the following inflammatory diseases:

Rheumatoid arthritis
Juvenile idiopathic polyarticular 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

The active ingredient of Yuflyma, adalimumab, is a human monoclonal antibody. Monoclonal antibodies
are proteins that bind to a specific target in the body.
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, Yuflyma decreases the inflammatory process of these
diseases.

Arthritis associated with enthesitis
Arthritis associated with enthesitis is an inflammatory disease of the joints and areas where the
tendons attach to the bones.
Yuflyma is used to treat arthritis associated with enthesitis in patients 6 years of age or older. You
may first receive other disease-modifying drugs, such as methotrexate. If you do not respond
adequately to these drugs, Yuflyma will be administered to you.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints usually associated with psoriasis.
Yuflyma is used to treat psoriatic arthritis in adults. Yuflyma may slow the damage to the
joints caused by the disease and may help you move more freely. Other medications may be
taken initially. If you do not respond adequately to these drugs, Yuflyma will be administered to you.

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 therapy and phototherapies have not worked optimally 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. More
often 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.
Yuflyma is used to treat

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

Crohn’s disease
Crohn’s disease is an inflammatory disease of the digestive tract. Yuflyma 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 medications may be taken initially. If you do not respond adequately to these drugs, Yuflyma will be
administered to you.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large intestine.
Yuflyma 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 you do not respond adequately to these drugs, Yuflyma will be
administered to you.

Non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye. Yuflyma is used
to treat

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 Yuflyma

Do not use Yuflyma:

if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
In the presence of 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.
In the presence of 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 Yuflyma.
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 Yuflyma 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 infections located in one part of the body (for example, leg ulcers), consult your doctor before starting treatment with Yuflyma. If you have any doubts, contact your doctor.
You may be more likely to get infections during treatment with Yuflyma. 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 infection (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 coming back 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 Yuflyma. You and your doctor should pay particular attention to signs of infection during treatment with Yuflyma. 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 Yuflyma if you have active tuberculosis.
Because cases of tuberculosis have occurred in patients treated with Yuflyma, your doctor will need to check if you have signs or symptoms of tuberculosis before starting therapy with Yuflyma. 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 hepatitis B virus infection, 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 Yuflyma 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 Yuflyma. Your doctor may advise temporarily stopping Yuflyma. 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 Yuflyma. 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 Yuflyma.
Consult your doctor before getting vaccinated.
It is recommended, if possible, to have children vaccinated for their age before starting treatment with Yuflyma.
If you have taken Yuflyma during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose of Yuflyma received during pregnancy. It is important that you tell your pediatrician or other healthcare provider about your use of Yuflyma 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 receiving concomitant treatment with Yuflyma, your doctor should carefully assess and monitor the condition of your heart. It is important to tell your doctor if you have had or have had serious heart problems in the past. 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 Yuflyma 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. The doctor may decide to
interrupt the therapy. If you have persistent fever, bruising or easy bleeding or
paleness, see your doctor immediately.
Tumor

Very rarely, some types of tumors have occurred in patients, both children and adults, treated with Yuflyma or other anti-TNF drugs.
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 Yuflyma, 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 Yuflyma. 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 Yuflyma.
Cases of non-melanoma skin cancer have been observed in patients taking Yuflyma.
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 tumors, 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.

Autoimmune disease

Rarely, treatment with Yuflyma can lead to the development of a syndrome similar to 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 already had all vaccinations before using Yuflyma.

anakinra
abatacept.

Yuflyma 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 any 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 Yuflyma.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice on taking this medicine.
Yuflyma 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 Yuflyma during pregnancy, compared to mothers with the same condition who did not receive Yuflyma.
Yuflyma can be used during breastfeeding.
If you take Yuflyma 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 Yuflyma during pregnancy, before the baby receives any type of vaccination. For further information on vaccinations, see the section “Warnings and precautions”.

YUFLYMA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 0.4 mL dose, i.e. essentially
“sodium-free”.

3. How to use Yuflyma

a 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?	m Notes
Adults	40 mg every other week l e d a	In rheumatoid arthritis r continue to take the a methotrexate during the treatment with Yuflyma. If the F doctor decides that methotrexate is not appropriate, Yuflyma can be administered alone. If you have rheumatoid arthritis and are not taking methotrexate in association with Yuflyma, your doctor may decide to prescribe 40 mg of Yuflyma every week or 80 mg every other week.

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

Arthritis associated with enthesitis
a Age or body weight	How much should be taken and how often?	Note
i z Children, adolescents and adults aged 6 years and over with weight equal to or greater than 30 kg	40 mg every other week	Not applicable
n 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

g Plaque psoriasis
A Age or body weight	How much should be taken and how often?	Note
Adults	First dose of 80 mg (two injections of 40 mg in one day), followed by 40 mg per week	In case of inadequate response the doctor may increase the

	every other week, starting one week after the first dose.	o dosage to 40 mg every week or 80 mg every other week.
Children and adolescents aged 4 to 17 years with weight equal to or greater than 30 kg	First dose of 40 mg, followed by 40 mg one week later. Subsequently, the usual dose is 40 mg every other week.	c Not applicable a
Children and adolescents aged between 4 and 17 years and weighing between 15 kg and less than 30 kg	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

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

z Crohn’s disease
n Age or body weight	How much should be taken and how often?	Note
e Children, adolescents and adults aged 6 years and over with weight equal to or greater than 40 kg A	First dose of 80 mg (two injections of 40 mg in one day), followed by 40 mg two weeks later. If a faster response is needed, the doctor may prescribe an initial dose of 160 mg (four	The doctor may increase the dose to 40 mg every week or 80 mg every other week.

	injections of 40 mg in one day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (two injections of 40 mg in one day) after two weeks. Subsequently, the usual dose is 40 mg every other week.	m a c o
Children and adolescents aged between 6 and 17 years and weighing less than 40 kg	Initial dose of 40 mg followed by 20 mg after two weeks. If a faster response is needed, the doctor may prescribe an initial dose of 80 mg (two injections l of 40 mg in one day), followed e by 40 mg after two weeks. d Subsequently, the usual dose is 20 mg every other week.	The doctor may increase the frequency of the dose to 20 mg every week. F

a Ulcerative colitis
Age or body weight	n How much should be taken and how often?	Note
Adults	a First dose of 160 mg (four injections of 40 mg in one day or i two injections of 40 mg per day for two consecutive days), l followed by 80 mg (two injections a of 40 mg in one day) after two weeks. t I 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 aged 6 years and over and weighing less than 40 kg i z n	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. Subsequently, the usual dose is 40 mg every other week.	Continue to take Yuflyma at the usual dose, even after turning 18 years of age.
e Children and adolescents aged 6 years and over and weighing 40 kg or more g A	Initial dose of 160 mg (four injections of 40 mg in one day or two injections of 40 mg per day for two consecutive days), followed by 80 mg (two injections of 40 mg in one day) after two weeks. Subsequently, the dose	Continue to take Yuflyma at the usual dose, even after turning 18 years of age.

usual dose is 80 mg every other week.

Non-infectious uveitis
Age or body weight	How much should be taken and how often?	c Note
Adults	First dose of 80 mg (two injections of 40 mg in one day), followed by 40 mg every other week starting one week after the first dose.	a m Corticosteroids or other drugs that affect the immune system may be continued during treatment with Yuflyma. Yuflyma can also be administered as monotherapy.
Children and adolescents aged 2 years and over and weighing less than 30 kg	20 mg every other week l e	a F 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 Yuflyma is recommended in association with methotrexate.
Children and adolescents aged 2 years and over weighing 30 kg or more	d 40 mg every other week a n	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 Yuflyma is recommended in association with methotrexate.

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

If you stop using Yuflyma
The decision to stop using Yuflyma must be discussed with your doctor. Symptoms may
return if you stop using Yuflyma.
If you have any doubts about the use of 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. However, some may be serious and require treatment. Side effects
may occur up to 4 months after the last injection of Yuflyma.

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 during 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
feeling of weakness/fatigue
cough
tingling
numbness
double vision
weakness of 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
Yuflyma.

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
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 cold sores)
reproductive system infections
urinary tract infection
fungal infections
infections affecting the joints
benign tumors
skin tumor
allergic reactions (including seasonal allergy)
dehydration
mood changes (including depression)
anxiety
difficulty sleeping
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
hematoma (blood accumulation outside of blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heartburn)
acid reflux disorder
dry eye syndrome (including dry eyes and dry mouth)
itching
itchy rash
bruising
skin inflammation (such as eczema)
breaking of fingernails and toenails
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
impaired wound 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)
tumor
lymphatic system tumor
melanoma
immune system disorders that can affect lungs, skin and lymph nodes (which most commonly present as
sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (nervous system disorder)
stroke
hearing loss, tinnitus
feeling of irregular heartbeat such as palpitations
heart problems that can cause shortness of breath or swelling at the ankles
heart attack
an aneurysm in 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
hepatitis B reactivation
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, reddish-purple rash) Not known(frequency cannot be estimated based on 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 appears as 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 Yuflyma 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
reduced platelets in the blood
increased uric acid in the blood
alteration of sodium in the blood
reduced calcium in the blood
reduced phosphate 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 (blood test related to the liver)

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

5. How to store Yuflyma

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/outer packaging after the
writing 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 of Yuflyma may be
stored at room temperature (up to 25°C) for a maximum period of 31 days; ensure that you
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 31 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 Yuflyma contains
The active ingredient is adalimumab.
The other ingredients are acetic acid, sodium acetate trihydrate, glycine, polysorbate 80, and water for
injections.

Description of the appearance of Yuflyma pre-filled pen and contents of the pack
Yuflyma 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.
Yuflyma pre-filled pen is a single-use injection system with automatic needle function. There is a window on
each side of the pen through which the solution of Yuflyma
inside the pen can be seen.
Yuflyma pre-filled pen is available in packs containing 1, 2, 4 and 6 pre-filled pens. The
pack of 1 pre-filled pen is supplied with 2 alcohol swabs (1 spare). In packs
of 2, 4 and 6 pre-filled pens, each pre-filled pen is supplied with 1 alcohol swab.
Not all pack sizes may be marketed.
Yuflyma may be available as a pre-filled syringe and/or pre-filled pen.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary

België/Belgique/Belgien
Celltrion Healthcare Belgium BVBA
Tél/Tel: + 32 1528 7418

Lietuva
Celltrion Healthcare Hungary Kft.
Tel.: +36 1 231 0493

България
Celltrion Healthcare Hungary Kft.
Teл.: +36 1 231 0493

Luxembourg/Luxemburg
Celltrion Healthcare Belgium BVBA
Tél/Tel: + 32 1528 7418

Česká republika
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

Magyarország
Celltrion Healthcare Hungary Kft.
Tel.: +36 1 231 0493

Danmark
Celltrion Healthcare Denmark ApS
Fuglevangsvej 11, 1962
Frederiksberg C, Denmark
[email protected]
Tlf: +45 35352989

Malta
Mint Health Ltd.
Tel: +356 2093 9800

DeutschlandNederland
Celltrion Healthcare Deutschland GmbH
Tél.: +49 (0)30 346494150
[email protected]
Celltrion Healthcare Netherlands B.V.
Tel: + 31 20 888 7300

Eesti
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

Norge
Celltrion Healthcare Norway AS
Fjordalléen 16, 0250 Oslo, Norway
[email protected]

España
Kern Pharma, S.L.
Tel: +34 93 700 2525

Österreich
Astro-Pharma GmbH
Tel: +43 1 97 99 860

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30 210 8009111

Polska
Celltrion Healthcare Hungary Kft.
Tel.: +36 1 231 0493

France
Celltrion Healthcare France SAS
Tél.: +33 (0)1 71 25 27 00

Portugal
PharmaKERN Portugal - Produtos Farmacêuticos,
Sociedade Unipessoal, Lda.
Tel: +351 214 200 290

Hrvatska
Oktal Pharma d.o.o.
Tel: +385 1 6595 777

România
Celltrion Healthcare Hungary Kft.
Tel. +36 1 231 0493

Ireland
Celltrion Healthcare Ireland Limited
Tel: +353 1 223 4026

Slovenija
OPH Oktal Pharma d.o.o.
Tel.: +386 1 519 29 22

Ísland
Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493

Slovenská republika
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

Italia
Celltrion Healthcare Italy S.r.l.
Tel: +39 02 47927040

Suomi/Finland
Celltrion Healthcare Finland Oy.
Puh/Tel: +358 29 170 7755

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741741

Sverige
Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493

United Kingdom (Northern Ireland)
Celltrion Healthcare Ireland Limited
Tel: +353 1 223 4026

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu

Latvija
Celltrion Healthcare Hungary Kft.
Tālr.: +36 1 231 0493

7. Instructions for Use

The following instructions explain how to perform a subcutaneous self-injection of Yuflyma 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-injection technique.
Do notproceed 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 pen exclusively for a single injection.

Yuflyma Penna pre-riempita

Two pre-filled pens with medicine, one before and one after

Do not use the pre-filled pen if:

it is cracked or damaged.
the expiry date has been exceeded.
it has fallen onto a hard surface.

Do not remove the cap until you are ready to administer the injection. Keep Yuflyma out of the reach of children.

1. Prepare the materials for the injection

a.Prepare a clean, flat surface, such as a table or shelf, in a well-lit area.
b.Remove 1 pre-filled pen from the box stored in the refrigerator.
c.Make sure you have the following materials:

Pre-filled pen
1 alcohol-soaked swab

Not included in the box:

Cotton ball or gauze
Adhesive bandage
Sharps disposal container

2. Inspect the pre-filled pen

a.Make sure you have the correct medicine (Yuflyma) and dosage
b.Look at the pre-filled pen and make sure it is not cracked or damaged.
c.Check the expiration date on the label of the pre-filled pen

Do notuse the pre-filled pen if:

it is cracked or damaged
the expiration date has passed.
it has fallen onto a hard surface.

White injectable pen with indicator and expiration date highlighted in a circle with an arrow

3. Inspect the medicine.

a.Look through the window and make sure the liquid is clear, from colorless to light brown and free of particles.

Do notuse the pre-filled pen if the liquid is discolored (yellow or dark brown), cloudy, or contains particles
You may see air bubbles in the liquid. This is normal.

Injectable pen with magnified viewing window showing the drug level all

4. Wait 15-30 minutes

a.Leave the pre-filled pen at room temperature for 15-30 minutes so that it can warm up.

Do notheat the pre-filled pen using heat sources such as hot water or a microwave.

Clock showing 15 and 30 minutes above a blue and white auto-injector pen on a gray background

15 – 30minutes

5. Choose an appropriate injection site

a.You can perform the injection:

on the front of the thigh.
in the abdomen, except for the area within 5 cm around the navel
in the outer area of the upper arm (ONLY if you are a person assisting the patient).

Do notperform the injection in skin areas within 5 cm of your navel or in an area that is reddened, hardened, painful, damaged, bruised, or scarred.
If you have psoriasis, do not perform the injection on any raised, thickened, reddened, or scaly patches or on any skin lesions.
Do notperform the injection through clothing.

b.Rotate the injection site each time you administer an injection. Each new injection site must be at least 3 cm away from the previously used site.

Human body diagram with areas colored in blue and gray indicating injection sites for patient and caregiver

6. Wash your hands.

a.Wash your hands with soap and water and dry them thoroughly.

Hand under the open tap with running water flowing towards the open palm

7. Clean the injection site

a.Clean the injection site with a swab soaked in alcohol, making a circular motion.
b.Allow the skin to dry before the injection.

Do not blow on the injection site or touch it again before performing the injection.

Bent knee with hand applying an adhesive bandage to the fair skin above the kneecap

8. Remove the cap

a.Hold the pre-filled pen with the body with the cap inserted with one hand. Gently pull the cap with the other hand.

Do notremove the cap until you are ready to administer the injection.
Do nottouch the needle or the needle cap. Doing so

Injectable pen with protected needle, directional arrow to the right

Cap
needle cover
may result in a needle stick injury.

Do notput the cap back on the pre-filled pen. Immediately dispose of the cap in a sharps container.
It is normal to see a few drops of liquid come out of the needle

9. Position the pre-filled pen on the injection site.

a.Hold the pre-filled pen so that you can see the window.
b.Without pinching or pulling the skin, position the pre-filled pen on the injection site at a 90-degree angle.

Hand holding an injection pen at a right angle to the skin, with an indication of 90° and an alternative injection option

10. Perform the injection

a.Press the pre-filled pen firmly against the skin. When the injection begins you will feel a first, strong and clear click, and the blue plunger will start to fill the window.
b.Continue to press the pre-filled pen firmly against the skin until you feel a second, strong and clear click
c.After hearing the second click, continue to hold the pre-filled pen firmly against the skin and count slowly to 5 to ensure you are injecting the complete dose.

Do notchange the position of the pre-filled pen once you have started the injection. 2 clicks

Hand using an injectable medical device with two phases indicated by arrows and counting from 1 to 5

1
click

2
click

Then, count slowly
to 5

11. Remove the pre-filled pen from the injection site and

take care of the injection site

a.Look at the pre-filled pen and make sure that the blue plunger rod with the grey cap completely fills the window.
b.Remove the pre-filled pen from the skin.

After you have removed the pre-filled pen from the injection site, the needle will be automatically covered. Do notreplace the cap on the pen.
If the window has not turned completely blue or if the medicine is still being injected, it means that you have not received a complete dose. Call your doctor immediately.

c.Treat the injection site by gently pressing a cotton ball or gauze over it, without rubbing, and, if necessary, applying an adhesive bandage. Some bleeding may occur.

Do not reuse the pre-filled pen.
Do not rub the injection site.

Hand holding a prefilled injector with a needle inserted into the skin and a magnifying glass

White injectable pen with blue needle and green protective cap indicated with an arrow and writing

Cap
needle cover

12. Dispose of the pre-filled pen

a.Immediately discard the used pre-filled pen in a special container for the disposal of sharp objects, as instructed by your doctor, nurse, or pharmacist.
b.The alcohol swab and packaging can be put in household waste.

Always keep the pre-filled pen and the special container for sharp objects out of sight and reach of children.

Automatic injection pen with exposed needle above a special waste container with a biological hazard symbol

Не уверены, подходит ли вам это лекарство?

Обсудите симптомы и варианты лечения с врачом онлайн.

Yuflyma 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 also provide you with a Patient Reminder Card, which contains important safety information that you should know before and during treatment with Yuflyma. Keep the Patient Reminder Cardwith you during your treatment and for 4 months after the last Yuflyma injection.
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, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Yuflyma and what is it used for

Yuflyma contains the active ingredient adalimumab, a medicine that acts on the immune system (the
body's defense).
Yuflyma is indicated for the treatment of the following inflammatory diseases:

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

The active ingredient of Yuflyma, adalimumab, is a human monoclonal antibody. Monoclonal antibodies
are proteins that bind to a specific target in the body.
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, Yuflyma reduces the inflammatory process of these
diseases.

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.
Yuflyma is used to treat chronic moderate to severe plaque psoriasis in adults.

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. More
frequently affects specific areas of the skin, such as the submammary region, armpits, inner
thighs, groin, and buttocks. Scars may also form in the affected areas.
Yuflyma is used to treat

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

Crohn’s disease
Crohn’s disease is an inflammatory disease of the digestive tract. Yuflyma 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 medications may be taken initially. If you do not respond adequately to these drugs, Yuflyma will be
administered to you.

Ulcerative colitis
Ulcerative colitis is an inflammatory disease of the large intestine.
Yuflyma 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 you do not respond adequately to these drugs, Yuflyma will be
administered to you.

Non-infectious uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye. Yuflyma is used
to treat

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). Yuflyma works by reducing
this inflammation.
Other medications may be taken initially. If you do not respond adequately to these drugs, Yuflyma will be
administered to you.

2. What you need to know before using Yuflyma

Do not use Yuflyma:

if you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
In the presence of 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.
In the presence of 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 Yuflyma.
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 Yuflyma 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 infections located in one part of the body (for example, leg ulcers), consult your doctor before starting treatment with Yuflyma. If you have doubts, contact your doctor.
You may be more likely to get infections during treatment with Yuflyma. 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 infection (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 of age, you may be more likely to get infections while taking Yuflyma. You and your doctor should pay particular attention to signs of infection during treatment with Yuflyma. 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 Yuflyma if you have active tuberculosis.
Because cases of tuberculosis have occurred in patients treated with Yuflyma, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Yuflyma. 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 in 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 must test you for hepatitis B virus infection. In HBV carriers, taking Yuflyma 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 Yuflyma. Your doctor may advise temporarily stopping Yuflyma. 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 Yuflyma. 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 Yuflyma.
Talk to your doctor before getting vaccinated.
It is recommended, if possible, to give children all the vaccinations recommended for their age before starting treatment with Yuflyma.
If you took Yuflyma during pregnancy, the baby may have a higher risk of contracting an infection up to about 5 months after the last dose of Yuflyma received during pregnancy. It is important that you tell your pediatrician or other healthcare provider about your use of Yuflyma 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 receiving concomitant treatment with Yuflyma, your doctor should carefully assess and monitor your heart condition. It is important to tell your doctor if you have had or have had serious heart problems in the past. 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 Yuflyma 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, seek medical attention immediately.

Cancer

In patients, both children and adults, undergoing treatment with Yuflyma or other anti-TNF drugs, very rare cases of certain types of cancer 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 Yuflyma, the risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a rare and serious type of lymphoma has been observed in patients treated with Yuflyma. Some of these patients were also taking azathioprine or 6-mercaptopurine.
Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Yuflyma.
Cases of non-melanoma skin cancer have been observed in patients taking Yuflyma.
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 cancers, other than 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.
Autoimmune disease
Rarely, treatment with Yuflyma can lead to the manifestation of a lupus-like syndrome. 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 already had all vaccinations before using Yuflyma.

anakinra
abatacept.

Yuflyma 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 it for at least 5 months after the last therapy with Yuflyma.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice about taking this medicine.
Yuflyma 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 Yuflyma during pregnancy, compared to mothers who had the same condition but had not received Yuflyma.
Yuflyma can be used during breastfeeding.
If you take Yuflyma 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 Yuflyma during pregnancy before the baby receives any type of vaccination. For further information on vaccinations, see the section “Warnings and precautions”.

Driving and using machines
Yuflyma may have a mild effect on your ability to drive, ride a bicycle or use machines.
After taking Yuflyma, you may experience visual disturbances and a sensation that the environment around you is rotating.

YUFLYMA 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 Yuflyma

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

t Plaque Psoriasis
Age or body weight	I How much should be taken and how often?	Notes
a Adults i	First dose of 80 mg (one injection of 80 mg on one day), followed by 40 mg every other week, starting one week after the first dose.	In case of inadequate response the doctor may increase the dosage to 40 mg every week or 80 mg every other week.

n Hidradenitis Suppurativa
e Age or body weight	How much should be taken and how often?	Notes
g Adults A	First dose of 160 mg (two injections of 80 mg on one day or one injection of 80 mg per day, for two consecutive days), followed by a dose of 80 mg (one injection of 80 mg on one day) two weeks later.	It is recommended to use an antiseptic cleansing solution on the affected areas every day.

	After another two weeks, continue with a dose of 40 mg every week or 80 mg every two weeks, as prescribed by the doctor.	c o
Adolescents from 12 to 17 years of age with weight equal to or greater than 30 kg	First dose of 80 mg (one injection of 80 mg on one day), followed by 40 mg every other week, starting from the following week.	a In case of inadequate response to Yuflyma 40 mg 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.

F Crohn’s Disease
Age or body weight	How much should be taken and how often?	Notes
Children, adolescents and adults from 6 years of age with weight equal to or greater than 40 kg	l e First dose of 80 mg (one injection of 80 mg on one day), d followed by 40 mg two weeks later. a If a faster response is needed, the doctor may prescribe an initial dose of 160 mg (two injections of 80 mg on one day or one a injection of 80 mg per day for two consecutive days), followed by i 80 mg (one injection of 80 l mg on one day) after two a weeks. t Subsequently, the usual dose is 40 mg every other week.	The doctor may increase the dose to 40 mg every week or 80 mg every other week.
Children and adolescents aged between 6 and 17 years with a weight less than 40 kg i z n e	I First dose of 40 mg, followed by 20 mg two weeks later. If a faster response is needed, the doctor may prescribe an initial dose of 80 mg (one injection of 80 mg), 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
A Age or body weight	How much should be taken and how often?	Notes
Adults	First dose of 160 mg (two injections of 80 mg on one day or	The doctor may increase the dosage to 40 mg every week

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

Non-infectious Uveitis
Age or body weight	n How much should be taken and how often?	Notes
Adults	a i First dose of 80 mg (one injection of 80 mg on one day), l followed by 40 mg every other a week starting one week after the first dose. t	Corticosteroids or other drugs that affect the immune system may be continued during treatment with Yuflyma. Yuflyma can also be administered as monotherapy.
Children and adolescents from 2 years of age and with weight less than 30 kg i z	I 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 Yuflyma is recommended in combination with methotrexate.
n Children and adolescents from e 2 years of age with weight of at least 30 kg g A	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 Yuflyma is recommended in combination with methotrexate.

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

If you stop using Yuflyma
The decision to stop using Yuflyma should be discussed with your doctor. Symptoms may
return if you stop using Yuflyma.
If you have any doubts about using this medicine, ask 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
feeling of weakness/fatigue
cough
tingling
numbness
double vision
weakness of 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
Yuflyma.

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 cold sores)
reproductive system infections
urinary tract infection
fungal infections
infections affecting the joints
benign tumors
skin cancer
allergic reactions (including seasonal allergy)
dehydration
mood changes (including depression)
anxiety
difficulty sleeping
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 rotation)
feeling of a fast heartbeat
high blood pressure
hot flashes
hematoma (blood accumulation outside of blood vessels)
cough
asthma
shortness of breath
gastrointestinal bleeding
dyspepsia (indigestion, bloating, heartburn)
acid reflux
dry syndrome (including dry eyes and mouth)
itching
itchy skin rash
bruising
skin inflammation (such as eczema)
breaking of fingernails and toenails
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
impaired wound healing 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)
tumor
lymphatic system tumor
melanoma
immune system disorders that can affect lungs, skin and lymph nodes (which most commonly present as
sarcoidosis)
vasculitis (inflammation of blood vessels)
tremor (shaking)
neuropathy (nervous system disorder)
stroke
hearing loss, ringing
feeling of irregular heartbeat such as palpitations
heart problems that can cause shortness of breath or swelling at the ankles
heart attack
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 lung 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)

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 lung)
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 skin 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 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 tumor associated with human herpes virus 8 infection. Kaposi's sarcoma most
commonly appears as 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 Yuflyma 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
reduced platelets in the blood
increased uric acid in the blood
alteration of sodium in the blood
reduced calcium in the blood
reduced phosphate 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 (blood test related to the liver)

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

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Yuflyma

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/outer packaging after the
wording Exp..
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringe with the needle safety device in the outer packaging to
protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled syringe with a safety device for the needle of Yuflyma can be stored at room temperature (up to 25°C) for a maximum period of 31 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 31 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 Yuflyma contains
The active substance is adalimumab.
The other ingredients are acetic acid, sodium acetate trihydrate, glycine, polysorbate 80, and water for
injections.

Description of the appearance of Yuflyma pre-filled syringe with safety device for the needle and
contents of the pack
Yuflyma 80 mg solution for injection in a pre-filled syringe with safety device for the needle is supplied
as a sterile solution of 80 mg of adalimumab dissolved in 0.8 mL of solution.
The Yuflyma pre-filled syringe is a glass syringe containing a solution of adalimumab. The
pack of 1 pre-filled syringe is supplied with 2 alcohol swabs (1 spare).
The Yuflyma pre-filled syringe is a glass syringe with a needle shield containing a solution of
adalimumab. The 1 pre-filled syringe with needle protection pack is supplied with 2 alcohol
swabs (1 spare).
Yuflyma may be available as a pre-filled syringe and/or pre-filled pen.