IDACIO 40 mg /0.8 Ml Инъекционный Раствор

Содержание инструкции

1. Idacio 40 mg injectable solution in pre-filled syringe
   1. What is Idacio and what is it used for
   2. What you need to know before you use Idacio
   3. How to use Idacio
   4. Possible side effects
   5. How to store Idacio
   6. Contents of the pack and other information
   7. Instructions for Use
2. Idacio 40 mg injectable solution in pre-filled pen
   1. What is Idacio and what is it used for
   2. What you need to know before using Idacio
   3. How to use Idacio
   4. Possible side effects
   5. How to store Idacio
   6. Contents of the pack and other information
   7. Instructions for Use
3. Idacio 40 mg/0.8 ml injectable solution for paediatric use
   1. What is Idacio and what is it used for
   2. What you need to know before using Idacio
   3. How to use Idacio
   4. Possible side effects
   5. How to store Idacio
   6. Contents of the pack and other information
   7. Instructions for Use

Idacio 40 mg injectable solution in pre-filled syringe

adalimumab

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

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a patient reminder card, which contains important safety information that you need to know before administering Idacio and during treatment with Idacio. Keep this patient reminder card during treatment and for 4 months after the last Idacio injection (yours or your child’s).
• 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 or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Idacio and what is it used for

Idacio contains the active ingredient adalimumab, a medication that acts on your immune system
(defense system).
Idacio is indicated for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis and
• non-infectious uveitis

The active ingredient contained in Idacio, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target in the body.
The target of adalimumab is another protein called tumor necrosis factor (TNFα), which is
present at higher concentrations in the inflammatory diseases listed above. By binding to
TNFα, Idacio blocks its action and decreases inflammation in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
Idacio is used to treat rheumatoid arthritis in adults. If you have rheumatoid arthritis of moderate to severe degree, other disease-modifying drugs, such as
methotrexate, may be initially administered. If these drugs do not work satisfactorily enough, you will be given
Idacio to treat rheumatoid arthritis.
Idacio can also be used for the therapy of severe, active and progressive rheumatoid arthritis not
previously treated with methotrexate.
Idacio may slow the progression of cartilage and bone damage in the joints, caused
by the disease, and improve physical function.
Generally Idacio is used with methotrexate. If your doctor believes that treatment with methotrexate
is not appropriate, Idacio may be administered alone.
Polyarticular Juvenile Idiopathic Arthritis and Arthritis Associated with Enthesitis
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis are inflammatory diseases
that generally manifest during childhood.
Idacio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents of
ages 2 to 17 years and arthritis associated with enthesitis in children and adolescents of 6-17 years of age. Other disease-modifying drugs, such as methotrexate, may be administered to patients. If
these drugs do not work satisfactorily enough, they will be given Idacio for
treatment of polyarticular juvenile idiopathic arthritis or arthritis associated with enthesitis.
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of spondylitis
are inflammations of the spine.
Idacio is used to treat these conditions in adults. If you suffer from ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will be administered
other drugs first. If these drugs do not work satisfactorily enough, you will be
administered Idacio to reduce the signs and symptoms of the disease.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Idacio is used to treat psoriatic arthritis in adults. Idacio may slow the damage to cartilage
and bone in the joints, caused by the disease, and improve physical function.
Plaque Psoriasis in Adults and Children
Plaque psoriasis is an inflammatory condition that causes reddish, scaly, and hardened patches on the skin. Plaque psoriasis can also affect the nails, causing them to break, thicken, and lift from their bed, which can be painful. Psoriasis is believed to be
caused by a problem with the body's immune system that leads to increased production
of skin cells.
Idacio is used to treat moderate to severe plaque psoriasis in adults. Idacio is also
used to treat severe plaque psoriasis in children and adolescents from 4 to 17 years of age in whom
medicines applied to the skin and treatment with UV rays have not worked optimally
or are not indicated.
Hidradenitis Suppurativa in Adults and Adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a chronic inflammatory disease of
the skin and is often painful. Symptoms may include painful nodules and abscesses (cysts) that may drain
pus. It most frequently affects specific areas of the skin, such as the submammary region, the armpits,
the inner thighs, the groin, and the buttocks. Scars can also form in the affected areas.
Idacio is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and older. Idacio may reduce the number of nodules and abscesses and the pain often associated with this disease.
Initially, you may receive other medications. If these medications do not work in a
satisfactory manner, you will be administered Idacio.
Crohn’s Disease in Adults and Children
Crohn’s disease is an inflammation of the intestine.
Idacio is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you suffer
from Crohn’s disease, you will first be administered other medications. In the event that you do not respond
adequately to these medications, you will be administered Idacio to reduce the signs
and symptoms typical of Crohn’s disease.
Ulcerative Colitis in Adults and Children
Ulcerative colitis is an inflammatory disease of the large intestine.
Idacio is used to treat ulcerative colitis in adults and children aged 6 to 17 years. If you suffer
from ulcerative colitis, you may initially take other medications. If these medications do not work in a
satisfactory manner, you will be administered Idacio to reduce the signs and symptoms of the
disease.
Non-Infectious Uveitis in Adults and Children
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
Inflammation can lead to decreased vision and/or the presence of mobile bodies
in the eye (black spots or thin lines that move across the visual field). Idacio works by reducing
this inflammation.
Idacio is used for the treatment of:

• adults with non-infectious uveitis with inflammation affecting the back of the eye
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

2. What you need to know before you use Idacio

Do not use Idacio

• If you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have a severe infection, including tuberculosis, sepsis (blood infection) or other opportunistic infections (unusual infections associated with a compromised immune system). It

is important to tell your doctor if you have signs or symptoms of infection, such as e.g. fever, wounds,
feeling tired, dental problems (see “Warnings and precautions”).

• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Idacio
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 administer Idacio again and contact your doctor immediately, as these reactions can be life-threatening in rare cases.

Infections

• If you have an infection, including long-term or localized infections (e.g. leg ulcers), consult your doctor before starting treatment with Idacio. If you have any doubts, contact your doctor.
• You may be more likely to get infections during treatment with Idacio. This risk may increase if your lung function is reduced. These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infections of the body and sepsis (blood infection). In rare cases, these infections can be life-threatening. It is important to tell your doctor about symptoms such as fever, ulcers, feeling tired or dental problems. Your doctor may advise you to temporarily stop Idacio.

Tuberculosis

• Because cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if you have signs or symptoms of tuberculosis before starting therapy with Idacio. This will involve collecting a detailed medical assessment including your medical history and appropriate clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the patient reminder card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis may develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.

Travel/endemic infections

• Talk to your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Talk to your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection.

Hepatitis B virus

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

Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Idacio. You and your doctor should pay particular attention to signs of infection while you are being treated with Idacio. It is important to tell your doctor if symptoms of infections such as fever, ulcers, fatigue or dental problems appear.

Surgery or dental procedures

• If you are about to undergo surgery or dental procedures, tell your doctor that you are taking Idacio. Your doctor may advise you to temporarily stop the medicine.

Demyelinating diseases

• If you have or develop demyelinating diseases (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 Idacio. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness in your arms or legs, or numbness or tingling that affects any part of your body.

Vaccines

• Certain vaccines contain viruses or live but attenuated forms of bacteria that cause the disease and therefore should not be administered during treatment with Idacio in case of infections. Consult your doctor before getting vaccinated. In children, it is advisable, if possible, to implement the vaccination schedule according to age before starting therapy with Idacio. If you have taken Idacio during pregnancy, the child may have a higher risk of contracting this infection up to about 5 months after the last dose you took during pregnancy. It is important that you tell your pediatrician or other healthcare provider about your use of Idacio during pregnancy, so that they can decide when the child should receive any type of vaccination.

Heart failure

• It is important to tell your doctor about any heart problems, past or present. If you have mild heart failure and are receiving concomitant treatment with Idacio, your doctor should carefully assess and monitor heart function. 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.

Fever, bruising, bleeding or paleness

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

Tumors

• In children and adults, some types of tumors have very rarely occurred in patients treated with adalimumab or other anti-TNF drugs. Patients with severe and long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma or leukemia (a cancer that affects blood cells and bone marrow). If you are taking Idacio, the risk of developing lymphomas, leukemia or other tumors may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients treated with adalimumab. Some of these patients were also taking azathioprine or mercaptopurine. Tell your doctor if you are taking azathioprine or mercaptopurine with Idacio.
• In addition, cases of skin cancer other than melanoma have been observed in patients taking adalimumab. If new skin lesions appear during or after treatment, 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.
• Rarely, treatment with Idacio may lead to the manifestation of a syndrome like lupus. Inform your doctor if symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue occur.

Children and adolescents

• Vaccinations: if possible, children should have had all vaccinations before using Idacio.
• Do not administer Idacio to children with juvenile idiopathic polyarticular arthritis under the age of 2 years.
• Do not use the pre-filled syringe of 40 mg or the pre-filled pen of 40 mg if dosages other than 40 mg are recommended.

Other medicines and Idacio
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Idacio can be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), steroids or
analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Idacio must not be taken in combination with medicines containing the active ingredients anakinra or
abatacept due to the increased risk of developing serious infections. The association of adalimumab as
well as other TNF antagonists and anakinra or abatacept is not recommended based on the increased risk
of infections, including serious infections and other potential drug interactions. If you have any doubts, ask your doctor.

Pregnancy and breastfeeding
If you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before
taking this medicine.
It is recommended to avoid pregnancy and use adequate contraceptive measures during
the use of Idacio and for at least 5 months after the last injection of Idacio. If you become pregnant
you should contact your doctor.
Idacio should only be used during pregnancy if necessary.
According to a study conducted on pregnant women, no increased risk of
birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers
who had the same condition but had not received adalimumab.
Idacio can be used during breastfeeding.
If you take Idacio during pregnancy, the child may have a higher risk of contracting
an infection. It is important that you tell your pediatrician or other healthcare provider about your use of
Idacio during pregnancy, before the child receives any type of vaccination (for more
information on vaccinations, see the section on vaccinations).

Driving and using machines
Idacio may affect, albeit to a modest extent, your ability to drive, ride a bicycle
or use machines. After taking Idacio, you may experience vision disturbances and
a feeling that the environment around you is spinning (dizziness).

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

3. How to use Idacio

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
Idacio must be injected under the skin (subcutaneous use). Patients requiring a dose lower than
40 mg should use the Idacio presentation in a 40 mg vial.
The recommended dose of Idacio in each of the approved indications is shown in the following
table.

How and route of administration
Idacio is administered by injection under the skin (subcutaneous injection).
Detailed instructions on how to inject Idacio are provided in section 7 “Instructions for use”.

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

If you forget to use Idacio
If you forget to give an injection, you should inject the next dose of Idacio as soon as you remember.
Then resume the dose regularly according to the established dosage schedule if you had not
forgotten a dose.

If you stop treatment with Idacio
The decision to stop using Idacio must be discussed with your doctor. Symptoms may
return after stopping treatment.
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 Idacio.

Consult your doctor urgentlyif you notice any of the symptoms of an allergic reaction or
heart failure such as:

• severe skin rash, hives;
• swelling of the face, hands and, feet;
• difficulty breathing, difficulty swallowing;
• shortness of breath on exertion or when lying down or swollen feet.

Inform your doctor as soon as possibleif you notice any of the following reactions:

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

The following side effects have been observed with adalimumab.

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

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• skin rash;
• muscle 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;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections of the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, stabbing sensation or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• inflammation of the eyelids and eye swelling;
• dizziness (feeling of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flashes;
• hematoma (a solid swelling with coagulated blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (accumulation of fluid in the body that causes swelling of the affected tissue);
• fever;
• decreased platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing.

Uncommon(may affect up to 1 in 100 people)

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

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, a condition that 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 wall of the intestine);
• hepatitis (inflammation of the liver);
• 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 (life-threatening reaction with flu-like symptoms and blistering rash);
• facial edema (swelling) associated with allergic reactions;
• erythema multiforme (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, reddish-purple skin rash).

Not known(frequency cannot be estimated from available data)

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

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

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

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

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

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

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

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

5. How to store Idacio

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/box after the wording
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Keep the pre-filled syringe in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) a single pre-filled syringe of Idacio can be
stored at room temperature (up to 25°C) for a maximum period of 28 days – ensure to
protect the medicine from light. Once it has been removed from the refrigerator to be stored at
room temperature, the pre-filled syringe must be used within 28 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 Idacio contains

• The active substance is adalimumab. Each pre-filled syringe contains 40 mg of adalimumab in 0.8 ml of solution.
• The other ingredients are sodium phosphate monobasic dihydrate, sodium phosphate dibasic dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.

Description of the appearance of Idacio and contents of the pack
Idacio 40 mg injectable solution (injection) in a pre-filled syringe is supplied as 0.8 ml of
sterile, clear, colorless solution of 40 mg of adalimumab.
The pre-filled syringe of Idacio contains a glass pre-filled syringe with needle and
finger protection. Each pack contains 2 or 6 pre-filled syringes and 2 or 6 alcohol-soaked pads.
Idacio is available in a vial, pre-filled syringe, and pre-filled pen.

Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.Höhe
Germany

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36,
8055 Graz
Austria

Other sources of information
More detailed information on this medicine is available on the European Medicines
Agency website https://www.ema.europa.eu

7. Instructions for Use

Make sure to read, understand, and follow these instructions for use before injecting Idacio. Your
doctor should show you how to prepare and inject Idacio correctly using the pre-filled syringe before using it for the first time. Contact your doctor if you have any questions.

Note: Images are for illustrative purposes only
Read all instructions carefully before using Idacio pre-filled syringe.
Important information

• Use Idacio pre-filled syringe only if the healthcare professional has correctly instructed you on how to use the pre-filled syringe.
• Idacio is a single-use pre-filled syringe.
• Idacio pre-filled syringe has a transparent needle guard that covers the needle after the injection is completed.
• Children under 12 years of age are not allowed to self-inject, and the injection must be given by a trained adult.
• Keep Idacio pre-filled syringe and the container for special waste disposal out of the reach and sight of children.
• Do notshake. Shaking may damage the pre-filled syringe and the medicine.
• Do notuse the Idacio pre-filled syringe if the solution appears cloudy or has changed color or contains particles or flocculi. The solution should be clear and colorless.
• Do nottry to activate the transparent needle guard before the injection.
• Do notinsert your fingers into the opening of the transparent needle guard.
• Do notuse an Idacio pre-filled syringe that has been frozen or left in direct light.
• Do notuse Idacio pre-filled syringe if it has been dropped or damaged as the pre-filled syringe may be broken even if the break is not visible. Instead, use a new pre-filled syringe. Storage information
• Store the pre-filled syringe in its original packaging to protect it from light.
• Store the pre-filled syringe in a refrigerator between 2 °C and 8 °C.
• If necessary, for example when traveling, a single pre-filled syringe can be stored at room temperature for up to 28 days.

Familiarize yourself with Idacio pre-filled syringe
Before use
Transparent needle guard Plunger

Front view
Needle cap
Syringe chamber filled with
liquid (inside)

Rear view
After use
Transparent needle guard Plunger

Needle covered Spring of the needle
guard

Step 1 Prepare for the injection
Each pack of Idacio pre-filled syringe contains two or 6 syringes.

• 1.1Prepare a clean surface, such as a table or flat surface, in a well-lit area.
• 1.2You will also need (Figure A):
• an alcohol swab (included in the pack)
• a cotton ball or gauze, and
• a container for special waste. Open the special waste container so it is ready for use.

Figure A

• 1.3Remove the pack from the refrigerator (Figure B).
• 1.4Check the expiry date on the side of the pack (Figure B). Warning: Donot use beyond the expiry date

Figure B

• 1.5 Caution: Donot pick up the syringe by the plunger or the needle cap. Doing so may damage the syringe or activate the transparent needle guard. Take the syringe out of the original packaging:
• place 2 fingers in the middle of the transparent needle guard
• pull the syringe upwards and out of the pack (Figure C). Place it on a clean surface.

Figure C

• 1.6Put the remaining syringe(s) back into their original packaging in the refrigerator (Figure D). Refer to the storage information on how to store unused syringe(s).

Figure D

• 1.7Leave the syringe at room temperature for 30 minutes to allow the medicine to warm up. Injecting cold medicine can be painful. (Figure E).

Figure E

Warning: Donot heat the syringe in any other way, such as in the microwave, in hot water, or in direct sunlight.

Warning: Donot remove the needle cap to allow the syringe to reach room temperature.

Step 2 Wash your hands

• 2.1Wash your hands thoroughly with soap and water (Figure F) and dry them.

Warning:Gloves do not replace the need to wash your hands.

Figure F

Step 3 Check the pre-filled syringe

• 3.1Check the syringe to make sure that:
• The syringe, the transparent needle guard and the needle cap are not cracked or damaged (Figure G).

Figure G

• The needle cap is firmly attached (Figure H).

Figure H

• The spring of the needle guard is not extended (Figure I).

Figure I

Warning: Donot use the syringe if it shows any signs of damage.
If so, discard the syringe in a special waste container and contact your healthcare professional or pharmacist.

• 3.2Check the solution to make sure that:
• The solution is clear, colorless, and free of particles (Figure J). Warning: Donot use the syringe if the solution contains particles, or is cloudy or is colored or has flocculi.

Figure J

• 3.3Check the label to make sure that:
• The name on the syringe is Idacio (Figure K).
• The expiry date on the syringe has not passed (Figure K).

Figure K

Warning: Donot use the syringe if:

• The name on the syringe is not Idacio.
• The expiry date on the syringe has passed If so, discard the syringe in a special waste container and contact your healthcare professional or pharmacist.

Step 4 Choose the injection site

• 4.1Choose an injection site (Figure L):
• on the upper thighs.
• on the abdomen (inject at least 5 centimeters away from the navel)

Figure L

• 4.2Choose a different site (at least 2.5 cm from the previous injection site) each time to reduce redness, irritation, or other skin problems. Warning: Donot inject into an area that is sore, bruised, red, hardened, scarred, or where you have stretch marks. Warning:If you have psoriasis, do not inject on scaly lesions, red, thick, raised patches

Step 5 Clean the injection site
Step 5 Clean the injection site

• 5.1Rub the skin at the injection site with an alcohol swab to clean it. (Figure M)

Warning: Donot blow or touch the injection site after cleaning it.

Figure M

Step 6 Give the injection
Step 6 Give the injection

• 6.1Remove the needle cap
• Always hold the syringe by the needle guard.
• Hold the syringe upwards and pull the needle cap straight off (Figure N).

Figure N
You may see drops of liquid on the tip of the needle.

• Discard the needle cap. Warning: Donot touch the needle.
• 6.2Pinch the skin
• Hold the syringe like a pen.
• With your other hand, gently pinch the skin (without squeezing) to avoid injecting into a muscle (Figure O).

Figure O

• 6.3Insert the needle
• With a quick, short movement, push the needle fully into the skin at a 45° - 90° angle (Figure P).

Figure P

• After the needle has been inserted, leave the skin pinched.
• 6.4Inject
• Use your thumb to gently push the plunger all the way down (Figure Q).

Figure Q

• Give the plunger a final push to make sure the entire dose has been injected (Figure R).
• Hold the syringe firmly without moving it in the same angle (Figure R).

Figure R

Donot remove the needle from the skin when the plunger reaches the end.
Slowly release your thumb upwards.
This will allow the needle to move into its transparent guard which will fully cover it
(Figure S).

Figure S

Warning:Call your healthcare professional or pharmacist if:

• you have not injected the full dose or
• the transparent needle guard does not activate after the injection. Warning: Donot reuse a syringe in case of a partial injection. Donot try to put the cap back on the needle as you could prick yourself.
• 6.5If there is blood or solution on the injection site, gently press a cotton ball or gauze (Figure T).

Figure T

Step 7 Dispose of the syringe
Step 7 Dispose of the syringe

• 7.1After use, discard the unused syringe in a special waste container. (Figure U).

Figure U

Warning:keep the special waste container out of the sight and reach of children.

Warning:Donot throw the syringe in household waste.
If you do not have a container for special waste, you may use a household waste container
that:

• is made of sturdy plastic;
• can be closed with a puncture-resistant, tight-fitting lid; this will prevent the needles from escaping;
• is upright and stable during use,
• is leak-proof
• is appropriately labeled, i.e. warns of the presence of hazardous waste inside the container.
• 7.2When the special waste container is almost full, you must follow local guidelines for the correct disposal of special waste containers. Donot recycle the special waste container.

Step 8 Record your injection

• 8.1To remember when and where you need to make the next injection, you should keep a diary with the dates of injection and the site used for the injection (Figure V).

Figure V

Idacio 40 mg injectable solution in pre-filled pen

adalimumab

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

• Keep this leaflet. You may need to read it again.
• Your doctor will give you a patient reminder card, which contains important safety information that you need to know before administering Idacio and during treatment with Idacio. Keep this patient reminder card during treatment and for 4 months after the last injection of Idacio (yours or your child’s).
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Idacio and what is it used for

Idacio contains the active ingredient adalimumab, a medication that acts on your immune system
(defense).
Idacio is indicated for the treatment of the following inflammatory diseases:

• rheumatoid arthritis,
• polyarticular juvenile idiopathic arthritis,
• arthritis associated with enthesitis,
• ankylosing spondylitis,
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
• psoriatic arthritis,
• psoriasis,
• hidradenitis suppurativa,
• Crohn’s disease,
• ulcerative colitis and
• non-infectious uveitis

The active ingredient contained in Idacio, adalimumab, is a monoclonal antibody. Monoclonal
antibodies are proteins that bind to a specific target in the body.
The target of adalimumab is another protein called tumor necrosis factor (TNFα), which is
present at higher concentrations in the inflammatory diseases listed above. By binding to
TNFα, Idacio blocks its action and reduces inflammation in these diseases.
Rheumatoid Arthritis
Rheumatoid arthritis is an inflammatory disease of the joints.
Idacio is used to treat rheumatoid arthritis in adults. If you have moderate to severe rheumatoid arthritis, other disease-modifying drugs, such as
methotrexate, may be initially administered. If these drugs do not work satisfactorily enough, you will be given
Idacio to treat rheumatoid arthritis.
Idacio can also be used for the treatment of severe, active and progressive rheumatoid arthritis
without prior treatment with methotrexate.
Idacio may slow the progression of cartilage and bone damage in the joints caused
by the disease, and improve physical function.
Generally Idacio is used with methotrexate. If your doctor believes that treatment with methotrexate
is not appropriate, Idacio may be administered alone.
Polyarticular Juvenile Idiopathic Arthritis and Arthritis Associated with Enthesitis
Polyarticular juvenile idiopathic arthritis and arthritis associated with enthesitis are inflammatory diseases
that generally manifest during childhood.
Idacio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents of
ages 2 to 17 years and arthritis associated with enthesitis in children and adolescents aged 6-17 years. Patients may be given other disease-modifying drugs, such as methotrexate. If
these drugs do not work satisfactorily enough, they will be given Idacio for
the treatment of polyarticular juvenile idiopathic arthritis or arthritis associated with enthesitis.
Ankylosing Spondylitis and Axial Spondyloarthritis without Radiographic Evidence of Ankylosing Spondylitis
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of spondylitis
ankylosing are inflammations of the spine.
Idacio is used to treat these conditions in adults. If you suffer from ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will be given
other medications first. If these drugs do not work satisfactorily enough, you will be
given Idacio to reduce the signs and symptoms of the disease.
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Idacio is used to treat psoriatic arthritis in adults. Idacio may slow the damage to cartilage
and bone in the joints, caused by the disease, and improve physical function.
Plaque Psoriasis in Adults and Children
Plaque psoriasis is an inflammatory 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 their bed, which can be painful.
Psoriasis is believed to be caused by a problem with the body's immune system that leads to
increased production of skin cells.
Idacio is used to treat moderate to severe plaque psoriasis in adults. Idacio is also
used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom
medicines applied to the skin and treatment with UV rays have not worked optimally
or are not indicated.
Hidradenitis Suppurativa in Adults and Adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a chronic inflammatory disease of the
skin and is often painful. Symptoms may include painful nodules and abscesses (cysts) that can
drain pus. It most frequently affects specific areas of the skin, such as the submammary region,
armpits, inner thighs, groin and buttocks. Scars can also form in the affected areas.
Idacio is used to treat hidradenitis suppurativa in adults and adolescents aged 12 years and over. Idacio may reduce the number of nodules and abscesses and the pain often associated with this disease.
Initially, you may receive other medications. If these drugs do not work in a
sufficiently satisfactory manner, you will be given Idacio.
Crohn’s Disease in Adults and Children
Crohn’s disease is an inflammation of the intestine.
Idacio is used to treat Crohn’s disease in adults and children aged 6 to 17 years. If you suffer
from Crohn’s disease, you will first be given other medications. If you do not respond
adequately to these drugs, you will be given Idacio to reduce the signs
and symptoms typical of Crohn’s disease.
Ulcerative Colitis in Adults and Children
Ulcerative colitis is an inflammatory disease of the large intestine.
Idacio is used to treat moderate to severe ulcerative colitis in adults and children aged
between 6 and 17 years. If you have ulcerative colitis, you may initially take other medications.
If these drugs do not work satisfactorily enough, you will be given Idacio
to reduce the signs and symptoms of the disease.
Non-Infectious Uveitis in Adults and Children
Non-infectious uveitis is an inflammatory disease that affects some parts of the eye.
Inflammation can lead to decreased vision and/or the presence of mobile bodies
in the eye (black spots or thin lines that move across the visual field). Idacio works by reducing
this inflammation.
Idacio is used for the treatment of:

• adults with non-infectious uveitis with inflammation affecting the back of the eye
• children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye

2. What you need to know before using Idacio

Do not use Idacio

• if you are allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• if you have a severe infection, including tuberculosis, sepsis (blood infection) or other opportunistic infections (unusual infections associated with a weakened immune system). It

is important to tell your doctor if you have signs or symptoms of infection, such as for example fever, ulcers,
feeling tired, dental problems (see “Warnings and precautions”).

• if you have moderate or severe heart failure. It is important to tell your doctor if you have had or currently have a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Idacio
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 administer Idacio again and contact your doctor immediately as, in rare cases, these reactions can be life-threatening.

Infections

• If you have an infection, including long-term or localized infections (for example, leg ulcers), consult your doctor before starting treatment with Idacio. If you have any doubts, contact your doctor.
• You may be more likely to get infections during treatment with Idacio. This risk may increase if your lung function is reduced. These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infections of the body, as well as sepsis (blood infection). In rare cases, these infections can be life-threatening. It is important to tell your doctor if you have symptoms such as fever, wounds, feeling tired or dental problems. Your doctor may advise you to temporarily stop Idacio.

Tuberculosis

• Because cases of tuberculosis have occurred in patients treated with adalimumab, your doctor will need to check if you have signs or symptoms typical of tuberculosis before starting therapy with Idacio. This will involve collecting a detailed medical assessment including your medical history and appropriate clinical tests (e.g. a chest X-ray and a tuberculin test). The performance and results of these tests must be recorded on the patient reminder card. It is very important to tell your doctor if you have ever had tuberculosis, or if you have had close contact with people with tuberculosis. Tuberculosis may develop during therapy even if you have received preventive treatment for tuberculosis. Contact your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever) or other infections appear during or after therapy.

Travel/endemic infections

• Talk to your doctor if you have lived in or travelled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Talk to your doctor if you have had recurrent infections or if you have conditions that increase your risk of infection. Hepatitis B virus
• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active infection with the hepatitis B virus or if you think you may be at risk of contracting the hepatitis
• B virus. Your doctor should test you for hepatitis B virus infection. Taking adalimumab

can cause reactivation of the hepatitis B virus in carriers of this
virus. In some rare cases, especially if the patient is undergoing therapy with other drugs that
suppress the immune system, reactivation of the hepatitis B virus infection can
be life-threatening.
Age over 65 years

• If you are over 65 years of age, you may be more susceptible to infections while taking Idacio. You and your doctor should pay particular attention to signs of infection while you are being treated with Idacio. It is important to tell your doctor if symptoms of infections such as fever, ulcers, feeling tired or dental problems appear.

Surgery or dental procedures

• If you are about to have surgery or dental procedures, tell your doctor that you are taking Idacio. Your doctor may advise you to temporarily stop the medicine

Demyelinating diseases

• If you have or develop demyelinating diseases (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 Idacio. Tell your doctor immediately if you experience symptoms such as changes in vision, weakness in your arms or legs, or numbness and tingling that affects any part of your body.

Vaccines

• Certain vaccines contain viruses or live but attenuated forms of bacteria that cause the disease and should not be administered during treatment with Idacio in case of infections. Consult your doctor before getting vaccinated. In children, it is recommended, if possible, to implement the vaccination schedule according to age before starting therapy with Idacio. If you have taken Idacio during pregnancy, the baby may have a higher risk of contracting this infection up to about 5 months after the last dose you took during pregnancy. It is important that you tell your pediatrician or other healthcare provider about your use of Idacio during pregnancy, so that they can decide when the baby should receive any type of vaccination.

Heart failure

• It is important to tell your doctor about any heart problems, past or present. If you have mild heart failure and are receiving concomitant treatment with Idacio, your doctor will need to carefully assess and monitor your heart function. If new symptoms of heart failure appear or existing symptoms worsen (for example, shortness of breath or swelling of the feet), contact your doctor immediately.

Fever, bruising, bleeding or paleness

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

Cancers

• In children and adults, very rare cases of certain types of cancer have occurred in patients treated with adalimumab or other TNF antagonists. Patients with severe, long-standing rheumatoid arthritis may have a higher than average risk of developing lymphoma or

leukemia (a cancer that affects blood cells and bone marrow). If you take Idacio, the
risk of developing lymphomas, leukemia or other cancers may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients
treated with adalimumab. Some
of these patients were also taking azathioprine or mercaptopurine. Tell your
doctor if you are taking azathioprine or mercaptopurine with Idacio.

• In addition, cases of skin cancer other than melanoma have been observed in patients taking adalimumab. If new skin lesions appear during or after treatment, 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 TNF antagonist. If you suffer from COPD, or smoke heavily, you should discuss with your doctor whether treatment with a TNF antagonist is appropriate.
• Rarely, treatment with Idacio may lead to the manifestation of a syndrome like lupus. Tell your doctor if you experience symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue.

Children and adolescents

• Vaccinations: if possible, children should have had all vaccinations before using Idacio.
• Do not give Idacio to children with juvenile idiopathic polyarticular arthritis under the age of 2 years.
• Do not use the pre-filled syringe of 40 mg or the pre-filled pen of 40 mg if dosages other than 40 mg are recommended.

Other medicines and Idacio
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Idacio can be taken with methotrexate and other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), steroids or
analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
Idacio should not be taken at the same time as medicines containing the active ingredients anakinra or
abatacept due to the increased risk of serious infections. The combination of adalimumab
as well as other TNF antagonists and anakinra or abatacept is not recommended based on the increased
risk of infections, including serious infections and other potential drug interactions.
If you have any doubts, ask your doctor.

Pregnancy and breastfeeding
If you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before
taking this medicine.
It is recommended to avoid pregnancy and to use adequate contraceptive measures during
the use of Idacio and for at least 5 months after the last injection of Idacio. If you become
pregnant you should contact your doctor.
Idacio should only be used during pregnancy if necessary.
According to a study conducted on pregnant women, no increased risk of birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers
who had the same condition but had not received adalimumab.
Idacio can be used during breastfeeding.
If you take Idacio 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
Idacio during pregnancy, before the baby receives any type of vaccination (for more
information on vaccinations, see the section on vaccinations).

Driving and using machines
Idacio may affect, albeit to a modest extent, your ability to drive, ride a bicycle
or operate machinery. After taking Idacio, you may experience vision disturbances and a
feeling that the environment around you is rotating (dizziness).

Idacio 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 Idacio

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.
Idacio must be injected under the skin (subcutaneous use). Patients who require a dose lower than
40 mg must use the Idacio presentation in a 40 mg vial.
The recommended dose of Idacio in each of the approved uses is shown in the following table.

How and route of administration
Idacio is administered by injection under the skin (subcutaneous injection).
Detailed instructions on how to inject Idacio are provided in section 7 “Instructions for use”.

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

If you forget to use Idacio
If you forget to give an injection, you should inject the next dose of Idacio as soon as you remember.
Then resume the dose regularly according to the established dosage schedule if you had not
forgotten a dose.

If you stop using Idacio
The decision to stop using Idacio must be discussed with your doctor. Symptoms may
return after stopping treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Consult your doctor urgentlyif you notice any of the symptoms of an allergic reaction or
heart failure such as:

• severe skin rash, hives;
• 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 possibleif you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating, fatigue, weakness, or cough
• symptoms of nerve problems such as tingling, double vision; weakness of the arms or legs;
• signs of skin cancer such as swelling or sores that do not heal;
• signs and symptoms suggesting the onset of blood disorders, such as persistent fever, bruising, bleeding, paleness.

The following side effects have been observed with adalimumab.

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

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• skin rash;
• muscle 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;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• joint infections;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergies);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, prickling or numbness;
• migraine;
• symptoms of nerve root compression (including lower back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (a spinning sensation);
• feeling of a racing heartbeat;
• high blood pressure;
• hot flushes;
• hematoma (a solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of the fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in the urine;
• kidney problems;
• chest pain;
• edema (a build-up of fluid in the body that causes swelling of the affected tissue);
• fever;
• reduced platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections that occur when immune defenses are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors including tumors affecting the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• double vision;
• hearing loss, ringing in the ears;
• feeling of an irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease that causes shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal accumulation of fluid in the pleural space);
• inflammation of the pancreas that causes severe pain in the abdomen and back;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (build-up of fat in the liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (an autoimmune disease that causes 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, a condition that can cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• cardiac arrest;
• pulmonary fibrosis (scarring of the lungs);
• intestinal perforation (a hole in the wall of the intestine);
• hepatitis (inflammation of the liver);
• hepatitis B reactivation;
• 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 (a life-threatening reaction with flu-like symptoms and blistering rashes);
• facial edema (swelling) associated with allergic reactions;
• multiforme erythema (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy, reddish-purple skin rash).

Not known(frequency cannot be estimated from available data)

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

Some of the side effects observed with adalimumab 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 blood lipids;
• increased liver enzymes.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

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

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

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

5. How to store Idacio

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/box after the words
Exp. The expiry date refers to the last day of that month.
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 Idacio can be
stored at room temperature (up to 25°C) for a maximum period of 28 days – ensure to
protect the medicine from light. Once it has been removed from the refrigerator to be stored at
room temperature, the pre-filled pen must be used within 28 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 Idacio contains

• The active substance is adalimumab. Each pre-filled pen contains 40 mg of adalimumab in 0.8 ml of solution. The other components are disodium phosphate monohydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.

Description of the appearance of Idacio and contents of the pack
Idacio 40 mg injectable solution (injection) in a pre-filled pen is supplied as 0.8 ml of
clear, colorless sterile solution of 40 mg of adalimumab.
The pre-filled pen of Idacio contains a syringe with Idacio. Each pack contains 2 or 6 pre-filled pens and 2 or 6 alcohol-soaked pads.
Idacio is available in a vial, pre-filled syringe, and pre-filled pen.

Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.Höhe
Germany

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36,
8055 Graz
Austria

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website https://www.ema.europa.eu

7. Instructions for Use

Make sure to read, understand, and follow these instructions for use before injecting Idacio. Your
doctor should show you how to prepare and inject Idacio correctly using the pre-filled pen before using it for the first time. Contact your doctor if you have any questions.

Instructions for Use
Single-use pre-filled pen
(adalimumab) for subcutaneous
injection
40mg

Note: Images are for illustrative purposes only
Read all instructions carefully before using Idacio pre-filled pen.
Important Information

• Use Idacio pre-filled pen only if the healthcare professional has instructed you on how to use it correctly.
• The Idacio pre-filled pen is supplied as a single-use pre-filled pen to deliver a complete dose of adalimumab. Always give the injection using the technique that the healthcare professional has taught you. Children under 12 years of age are not allowed to self-inject and the injection must be given by a trained adult. Keep Idacio pre-filled pen out of the reach of children. Do notinsert your fingers into the protective opening. Do notuse a pre-filled pen that has been frozen or left in direct light. Talk to your healthcare professional if you have any questions or concerns. Storage Information
• Store the pre-filled pen in its original packaging to protect it from light.
• Store the pre-filled pen in a refrigerator between 2°C and 8°C.
• If necessary, for example when travelling, a single pre-filled pen can be stored at room temperature for up to 28 days.

Become familiar with Idacio pre-filled pen
Transparent syringe
chamber
Space for label
(Idacio, dosage, expiry date)

Before
use
Injection
button

Syringe
plunger
cap
Injection
body
needle
Needle cap

After use

Needle

Extended
safety
device
Syringe plunger final position

Step 1Prepare for the injection
Each pack of Idacio pre-filled pen contains two or six pre-filled pens.

• 1.1Prepare a clean surface, such as a table or flat surface, in a well-lit area.
• 1.2You will also need (Figure A):
• an alcohol swab (included in the pack)
• a cotton ball or gauze, and a container for special waste.

Figure A

• 1.3Remove the pack from the refrigerator (Figure B).

Figure B

• 1.4Check the expiry date on the side of the pack (Figure C).

Figure C

Warning:Do notuse beyond the expiry date.

• 1.5Take a pre-filled pen out of the original pack:
• place two fingers on the label area
• pull the pre-filled pen upwards and out of the pack (Figure D).

Figure D
Place it on a clean surface.

• 1.6Put the remaining pre-filled pen(s) back into their original packaging in the refrigerator (Figure E).

Figure E
Refer to the storage information for how to store unused pre-filled pen(s).

• 1.7Leave the pre-filled pen at room temperature for at least 30 minutes to allow the medicine to warm up (Figure F).

Figure F
Injecting cold medicine can be painful.

Warning:Do notheat the pre-filled pen in any other way, such as in the microwave,
in hot water, or in direct sunlight.

Warning:Do notremove the needle cap until you are ready to inject.

Step 2 Wash your hands

• 2.1Wash your hands thoroughly with soap and water (Figure G) and dry them. Warning:gloves do not replace the need to wash your hands.

Figure G

Step 3 Check the pre-filled pen

• 3.1Check the transparent syringe chamber to make sure that:
• the solution is clear, colourless, and free of particles (Figure H).
• The glass syringe is not cracked or broken (Figure H).

Transparent syringe chamber

Figure H

Warning:Do notuse the pre-filled pen if the solution contains particles, or is cloudy or if it is
coloured or has flocculi or shows any signs of damage.
If so, discard it in a special waste container and contact your healthcare professional or
pharmacist.

• 3.2Check the label to make sure that: the name on the pre-filled pen is Idacio (Figure I). the expiry date on the pre-filled pen has not passed (Figure I).

Figure I

Warning:Do notuse the pre-filled pen if the name on the label is not Idacio and/or the expiry
date has passed.
If so, discard the pre-filled pen in a special waste container and contact your healthcare
professional or pharmacist.

Step 4 Choose the injection site

• 4.1Choose an injection site (Figure J): On the upper thighs. On the abdomen (inject at least 5 centimetres away from the navel).

Figure J

• 4.2Choose a different site (at least 2.5 centimetres away from the previous injection site) each time to reduce the likelihood of redness, irritation or other skin problems. Warning: Do notinject into an area that is sore, bruised, reddened, hardened, scarred or where you have stretch marks. Warning: If you have psoriasis, do notinject on scaly lesions, red, thick, raised patches.

Step 5 Clean the injection site

• 5.1Rub the skin of the injection site with an alcohol swab to clean it. (Figure K).

Warning:Do notblow or touch the injection site after cleaning it.

Figure K

Step 6 Give the injection

• 6.1Remove the needle cap Hold the pre-filled pen upwards and pull the needle cap straight off. (Figure L).

Figure L
You may see a drop of liquid on the tip of the needle.
Discard the needle cap.

Warning:Do nottwist the cap.

Warning:Do notput the cap back on the pre-filled pen.

• 6.2Position the pre-filled pen Hold the pre-filled pen so that you can see the transparent syringe chamber. Place your thumb on the yellow injection button (withouttouching it) (Figure M).

Figure M
Position the pre-filled pen on the skin at a 90° angle (Figure N).

Figure N
Before the injection
Hold the pre-filled pen firmly and press against the skin until the safety shield
is fully lowered.
This will unlock the injection button (Figure O).

Figure O
Before the injection

• 6.3Give the injection Press the injection button (Figure P). You will hear a distinct click, which means the injection has started. Continue to HOLD the pre-filled pen firmly. WATCH the syringe plunger to make sure it moves and goes all the way down. (Figure P).

Figure P
After the injection

Warning:Do notlift the pre-filled pen from the skin until the plunger has
moved all the way down and all the liquid has been injected.
When the syringe plunger has moved down and stopped moving, continue to
hold it down for 5 seconds.
Lift the pre-filled pen from the skin. (Figure Q).
The safety shield will slide down and lock into place to protect you
from the needle. (Figure Q).

Figure Q

Warning:Contact your healthcare professional or pharmacist if you have any problems.

• 6.4If there is blood or fluid on the skin, treat the injection site by gently pressing a cotton ball or gauze (Figure R).

Figure R

Step 7 Dispose of the pre-filled pen

• 7.1Dispose of the used pre-filled pen in a sharps container immediately after use (Figure S).

Figure S

Warning:Keep the sharps container out of the reach of children.

Warning:Do notdispose of the pre-filled pen in household waste.
If you do not have a sharps container, you can use a container for household waste that:

• is made of strong plastic;
• can be closed with a tight-fitting, puncture-resistant lid; this will prevent needles from escaping;
• is upright and stable during use;
• is leakproof and
• is properly labelled to indicate the presence of hazardous waste inside the container.
• 7.2When the sharps container is almost full, you should follow local guidelines for the proper disposal of sharps containers. Do notrecycle the sharps container.

Step 8 Record the injection

• 8.1To remember when and where to give the next injection, you should keep a diary with the dates of injections and the site used for the injection (Figure T).

Figure T

Idacio 40 mg/0.8 ml injectable solution for paediatric use

adalimumab

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

• Keep this leaflet. You may need to read it again.
• The doctor will give you a patient reminder card, which contains important safety information, that you need to know before the child is given Idacio and during treatment with Idacio. You or the child keep this patient reminder card during treatment and for 4 months after the last injection of Idacio (yours or your child's).
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for the child. Do not give it to other people, even if they have the same symptoms as the child, because it could be dangerous.
• If the child gets any side effects, even those not listed in this leaflet, tell your paediatrician or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Idacio and what is it used for

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

• juvenile idiopathic polyarticular arthritis,
• arthritis associated with enthesitis,
• pediatric plaque psoriasis,
• hidradenitis suppurativa in adolescents,
• pediatric Crohn's disease,
• pediatric ulcerative colitis
• pediatric uveitis

The active ingredient contained in Idacio, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that bind to a specific target in the body.
The target of adalimumab is another protein called tumor necrosis factor (TNFα), which is
present in higher concentrations in the inflammatory diseases listed above. By binding to
TNFα, Idacio blocks its action and decreases inflammation in these diseases.
Juvenile idiopathic polyarticular arthritis and arthritis associated with enthesitis
Juvenile idiopathic polyarticular arthritis and arthritis associated with enthesitis are inflammatory diseases
that generally manifest during childhood.
Idacio is used to treat juvenile idiopathic polyarticular arthritis and arthritis associated with enthesitis. Other disease-modifying drugs, such as
methotrexate, may be administered to your child first. If these drugs do not work satisfactorily enough, Idacio will be
administered to the child for the treatment of juvenile idiopathic polyarticular arthritis or arthritis
associated with enthesitis.
Pediatric plaque psoriasis
Plaque psoriasis is an inflammatory skin condition that causes red, scaly
and hardened patches. Plaque psoriasis can also affect the nails, causing them to break, thicken and
lift from their bed, which can be painful. Psoriasis is believed to be caused by a
problem with the body's immune system that leads to increased production of skin
cells.
Idacio is used to treat moderate to severe plaque psoriasis in children and adolescents
aged 4 to 17 years in whom medicines applied to the skin and treatment with UV rays have not
worked optimally or are not indicated.
Hidradenitis suppurativa in adolescents
Hidradenitis Suppurativa (sometimes called inverse acne) is a chronic inflammatory skin disease often painful. Symptoms may include painful nodules and abscesses (cysts) that may
drain pus. It most frequently affects specific areas of the skin, such as the submammary region,
the armpits, the inner thighs, the groin and the buttocks. Scars can also form in the affected areas.
Idacio is used to treat hidradenitis suppurativa in adolescents aged 12 years and older. Idacio can
reduce the number of nodules and abscesses and the pain that is often associated with this disease. Initially,
you may receive other medicines. If these drugs do not work sufficiently
satisfactorily, Idacio will be administered to you.
Pediatric Crohn's disease
Crohn's disease is an inflammation of the intestine.
Idacio is used to treat Crohn's disease in children aged 6 to 17 years. Other medicines may be
administered to the child initially. If you do not respond adequately to these drugs, Idacio will be administered to the child to reduce the signs and
symptoms typical of Crohn's disease.
Ulcerative colitis in pediatric patients
Ulcerative colitis is an inflammatory disease of the large intestine. Idacio is used to treat moderate to severe ulcerative colitis in children aged 6 to 17 years. Other medicines may be
administered to the child initially. If these medicines do not work well enough, Idacio will be administered to the child to reduce the signs and symptoms of the disease.
Pediatric uveitis
Non-infectious uveitis is an inflammatory disease that affects certain parts of the eye.
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). Idacio works by reducing
this inflammation.
Idacio is used for the treatment of children from 2 years of age with chronic non-infectious uveitis with
inflammation affecting the front part of the eye

2. What you need to know before using Idacio

Do not use Idacio

• if the child is allergic to adalimumab or to any of the other ingredients of this medicine (listed in section 6).
• If the child has a severe infection, including tuberculosis, sepsis (blood infection) or other opportunistic infections (unusual infections associated with a compromised immune system). It is important to tell the doctor if the child has signs or symptoms of infection, such as, for example, fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
• If the child suffers from moderate or severe heart failure. It is important to tell the doctor if the child has had or has a serious heart condition (see “Warnings and precautions”).

Warnings and precautions
Consult your pediatrician or pharmacist before using Idacio
Allergic reactions

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

Infections

• If the child has an infection, including chronic or localized infections (for example, leg ulcers), consult a doctor before starting treatment with Idacio. If you have doubts, contact your doctor.
• The child may be more likely to contract infections during treatment with Idacio. This risk may increase if their lung function is reduced. These infections can be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infections of the body and sepsis (blood infection). In rare cases, these infections can be life-threatening to the patient. It is important to tell the doctor if the child presents symptoms such as fever, wounds, feeling tired or dental problems. The doctor may advise temporarily stopping Idacio.

Tuberculosis

• Since cases of tuberculosis have occurred in patients treated with adalimumab, the doctor will need to check if the child presents signs or symptoms typical of tuberculosis before starting therapy with Idacio. This will involve collecting a detailed medical assessment including their medical history and appropriate clinical examinations (e.g. a chest X-ray and a tuberculin test). The execution and results of these tests must be recorded in the patient reminder card of your child. It is very important to tell the doctor if the child has ever had tuberculosis, or if they have had close contact with people with tuberculosis. Tuberculosis can manifest during therapy despite your child having received preventive treatment for tuberculosis. Contact

immediately the doctor if tuberculosis symptoms (persistent cough, weight loss, fatigue, moderate fever) or other infections appear during or after therapy.
Travel/endemic infections

• Consult your doctor if your child has lived or traveled to regions where fungal infections, such as histoplasmosis, coccidioidomycosis or blastomycosis, are common.
• Consult your doctor if your child has had recurrent infections or presents conditions that increase the risk of infection.

Hepatitis B virus

• Tell the doctor if your child is a carrier of the hepatitis B virus (HBV), has an active infection with the hepatitis B virus or thinks they may be at risk of contracting the hepatitis B virus. The pediatrician must test the child for hepatitis B virus infection. Taking adalimumab can cause reactivation of the hepatitis B virus in subjects who are carriers of this virus. In some rare cases, especially if the child is undergoing therapy with other drugs that suppress the immune system, reactivation of the hepatitis B virus infection can be life-threatening.

Symptoms of infections

• It is important to inform the pediatrician if symptoms of infections such as fever, ulcers, feeling tired or dental problems appear.

Surgery or dental procedures

• If the child is about to have surgery or dental procedures, tell the doctor that they are taking Idacio. The doctor may advise temporarily stopping the medication.

Demyelinating diseases

• If the child suffers from or develops demyelinating diseases (a disease that affects the insulating layer around the nerves such as multiple sclerosis), the doctor will decide whether or not to start or continue treatment with Idacio. Immediately inform the doctor if the child manifests symptoms such as altered vision, weakness of arms or legs or numbness or tingling that affects any part of the body.

Vaccines

• Certain vaccines contain viruses or live but attenuated forms of bacteria that cause the disease and must not be administered during treatment with Idacio. Consult your doctor before the child undergoes vaccinations. In children, it is advisable, if possible, to implement the vaccination schedule according to age before starting therapy based on Idacio. If you have taken Idacio during pregnancy, your child may have a higher risk of contracting infections up to about 5 months after the last dose you took during pregnancy. It is important that you inform the pediatrician or other healthcare provider of your use of Idacio during pregnancy, so that they can decide when the child should receive any type of vaccination.

Heart failure

• It is important to inform the doctor if the child has any heart problems, past or present. In case of mild heart failure and concomitant treatment with Idacio, the doctor must carefully evaluate and monitor their heart failure. If new symptoms of heart failure appear or existing symptoms worsen (for example, shortness of breath or swelling of the feet), contact your doctor immediately. The doctor will decide if your child can receive Idacio.

Fever, bruising, bleeding or paleness

• In some patients, the body may not be able to produce enough blood cells to help them fight infections or stop bleeding. If the child experiences persistent fever, bruising or ease of bleeding or paleness, consult a doctor immediately. The latter may decide to interrupt the therapy.

Tumors

• Very rarely, some types of tumors have occurred in children and adults undergoing treatment with adalimumab or other anti-TNF drugs. Patients with severe and long-lasting rheumatoid arthritis may have a higher than average risk of developing lymphoma or leukemia (a cancer that affects blood cells and bone marrow). If the child takes Idacio, the risk of contracting lymphomas, leukemia or other tumors may increase. In rare circumstances, a specific and serious type of lymphoma has been observed in patients undergoing therapy with adalimumab. Some of these patients were also undergoing therapy with azathioprine or mercaptopurine. Tell the doctor if the child is taking azathioprine or mercaptopurine with Idacio.
• In addition, cases of skin cancer other than melanoma have been observed in patients taking adalimumab. If new skin lesions appear during or after treatment or if the appearance of existing lesions changes, report it
• 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 the child suffers from COPD, they should discuss with the doctor whether treatment with an anti-TNF is appropriate.
• Rarely, treatment with Idacio can lead to the onset of a disease like lupus. Inform the doctor if symptoms such as a persistent unexplained skin rash, fever, joint pain or fatigue appear.

Other medicines and Idacio
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
Idacio can be taken both with methotrexate and with other disease-modifying antirheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide and parenteral gold salts), steroids or
analgesics, including non-steroidal anti-inflammatory drugs (NSAIDs).
The child should not take Idacio at the same time as medicines containing the active ingredients
anakinra or abatacept due to the increased risk of contracting serious infections. The association of
adalimumab as well as other TNF antagonists and anakinra or abatacept is not recommended based on
the increased risk of infections, including serious infections and other potential drug interactions.
If you have doubts, consult your doctor.

Pregnancy and breastfeeding
If you suspect that the girl is pregnant or is planning a pregnancy, ask your
doctor or pharmacist for advice before taking this medicine.
The girl is advised to avoid pregnancy and to use adequate contraceptive measures
during the use of Idacio and for at least 5 months after the last injection of Idacio. If the girl
becomes pregnant, she must contact the doctor.
Idacio should only be used during pregnancy if necessary.
According to a study conducted on pregnant women, no increased risk of
birth defects was found when the mother had received adalimumab during pregnancy, compared to mothers
who had the same condition but had not received adalimumab.
Idacio can be used during breastfeeding.
If the girl takes Idacio during pregnancy, her child may have a higher risk
of contracting an infection. It is important that you inform the pediatrician or other healthcare provider of her
use of Idacio during pregnancy, before the child receives any type of vaccination (for
more information on vaccinations, see the section on vaccinations).

Driving and using machines
Idacio may affect, albeit only to a modest extent, your ability to drive, ride a bicycle
or operate machinery. Following the administration of Idacio, visual disturbances and
a feeling that the environment around you is rotating (dizziness) may occur.

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

3. How to use Idacio

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts or require clarification, consult your pediatrician or pharmacist. Your doctor may prescribe a different
concentration of Idacio if the child needs a different dose.
Idacio is to be injected under the skin (subcutaneous use). A pre-filled syringe of
40 mg and a pre-filled pen of 40 mg are also available.
The recommended dose of Idacio in each of the approved uses is shown in the following table.

Arthritis associated with enthesitis

How and route of administration
Idacio is administered by injection under the skin (subcutaneous injection).
Detailed instructions on how to inject Idacio are provided in section 7 “Instructions for use”.

If you use more Idacio than you should
If you accidentally inject Idacio more frequently than prescribed by your doctor or pharmacist,
contact your pediatrician or pharmacist informing them that the child has taken more medicine than
required. Always keep the medicine box, even if empty.

If you use less Idacio than you should
If you accidentally inject a lower amount of Idacio, or if you inject it less frequently than
prescribed by your pediatrician or pharmacist, contact your pediatrician or pharmacist informing them that the
child has taken less medicine. Always keep the medicine box or vial, even if
empty.

If you forget to use Idacio
If you forget to give an injection to the child, you must inject the next dose of Idacio as soon as you
remember. Then administer the dose to the child regularly according to the established dosage schedule if you had not forgotten a dose.

If the child stops treatment with Idacio
The decision to stop using Idacio must be discussed with your pediatrician. Symptoms may
return after stopping treatment.
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 in severity. However, some may be serious and require
treatment. Side effects may occur up to 4 months after the last injection of Idacio.

Consult your doctor urgentlyif you notice any symptoms of an allergic reaction or of
heart failure such as:

• severe skin rash, hives;
• 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 possibleif you notice any of the following reactions:

• signs and symptoms of infection such as fever, feeling unwell, wounds, dental problems, burning when urinating, fatigue, weakness or cough;
• symptoms of nerve problems such as tingling, double vision; weakness of the arms or legs;
• signs of skin cancer such as swelling or sores that do not heal;
• signs and symptoms suggesting the onset of blood system disorders, such as persistent fever, bruising, bleeding, pallor.

The following side effects have been observed with adalimumab:

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

• reactions at the injection site (including pain, swelling, redness or itching);
• respiratory tract infections (including common cold, runny nose, sinusitis and pneumonia);
• headache;
• abdominal pain;
• nausea and vomiting;
• skin rash;
• muscle 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;
• mouth infections (including tooth infections and herpes simplex);
• reproductive system infections;
• urinary tract infections;
• fungal infections;
• infections of the joints;
• benign tumors;
• skin cancer;
• allergic reactions (including seasonal allergy);
• dehydration;
• mood changes (including depression);
• anxiety;
• sleep disorders;
• sensory disturbances such as tingling, pricking or numbness;
• migraine;
• symptoms of nerve root compression (including back pain and leg pain);
• visual disturbances;
• eye inflammation;
• eyelid inflammation and eye swelling;
• dizziness (feeling of spinning);
• feeling of a fast heartbeat;
• high blood pressure;
• hot flashes;
• hematoma (a solid swelling with clotted blood);
• cough;
• asthma;
• shortness of breath;
• gastrointestinal bleeding;
• dyspepsia (indigestion, bloating, heartburn);
• acid reflux;
• dry eye syndrome (including dry eyes and dry mouth);
• itching;
• itchy skin rash;
• bruising;
• skin inflammation (such as eczema);
• nail breakage of fingers and toes;
• increased sweating;
• hair loss;
• onset or worsening of psoriasis;
• muscle spasms;
• blood in urine;
• kidney problems;
• chest pain;
• edema (accumulation of fluid in the body that causes swelling of the affected tissue);
• fever;
• decreased platelets in the blood, which increases the risk of bleeding or bruising;
• difficulty healing wounds.

Uncommon(may affect up to 1 in 100 people)

• unusual infections (including tuberculosis and other infections that occur when immune defenses are reduced);
• neurological infections (including viral meningitis);
• eye infections;
• bacterial infections;
• diverticulitis (inflammation and infection of the large intestine);
• tumors including tumors affecting the lymphatic system (lymphoma) and melanoma (a type of skin cancer);
• immune system disorders that can affect the lungs, skin and lymph nodes (most commonly a condition called sarcoidosis);
• vasculitis (inflammation of blood vessels);
• tremor;
• neuropathy (nerve damage);
• stroke;
• double vision;
• hearing loss, ringing in the ears;
• feeling of irregular heartbeat such as palpitations;
• heart problems that can cause shortness of breath or swelling of the ankles;
• myocardial infarction (heart attack);
• formation of a sac in the wall of a major artery, inflammation and blood clot in a vein, blockage of a blood vessel;
• lung disease causing shortness of breath (including inflammation);
• pulmonary embolism (blockage of a pulmonary artery);
• pleural effusion (abnormal collection of fluid in the pleural space);
• inflammation of the pancreas causing severe abdominal and back pain;
• difficulty swallowing;
• facial edema (swelling);
• inflammation of the gallbladder, gallstones;
• fatty liver (accumulation of fat in liver cells);
• night sweats;
• scarring;
• abnormal muscle catabolism;
• systemic lupus erythematosus (an autoimmune disease that causes 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, a condition that 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 wall of the intestine);
• hepatitis (inflammation of the liver);
• hepatitis B reactivation;
• 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 (life-threatening reaction with flu-like symptoms and blistering rashes);
• facial edema (swelling) associated with allergic reactions;
• multiforme erythema (inflammatory skin rash);
• lupus-like syndrome;
• angioedema (localized swelling of the skin);
• lichenoid skin reaction (itchy red-violet rash).

Not known(frequency cannot be estimated from available data)

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

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

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

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

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

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

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

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

5. How to store Idacio

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/pack after the wording
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Alternative storage conditions:
When necessary (for example when travelling) Idacio can be stored at room temperature
(up to 25 °C) for a maximum period of 28 days – ensure the medicine is protected from light.
Once it has been removed from the refrigerator to be stored at room temperature, the vial

must be used within 28 days or discarded, even if it is placed back in the refrigerator.
You must record the date on which the vial is removed from the refrigerator for the first time and the date after
which it 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 Idacio contains

• The active substance is adalimumab. Each vial contains 40 mg of adalimumab in 0.8 ml of solution.
• The other ingredients are disodium phosphate monobasic dihydrate, disodium phosphate dibasic dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.

Description of the appearance of Idacio and contents of the pack
Idacio 40 mg injectable solution (injection) for paediatric use is supplied as 0.8 ml of clear, colourless solution containing 40 mg of adalimumab.
Idacio 40 mg/0.8 ml injectable solution for paediatric use is supplied in a glass vial.
Each pack contains 1 vial (0.8 ml of sterile solution), 1 sterile injection syringe, 1
sterile needle, 1 vial adapter, and 2 alcohol-soaked swabs.
Idacio is available in a vial, pre-filled syringe, and pre-filled pen.

Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1
61352 Bad Homburg v.d.Höhe
Germany

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstraße 36,
8055 Graz
Austria

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website https://www.ema.europa.eu

7. Instructions for Use

Make sure to read, understand and follow these instructions for use before injecting Idacio. Your
doctor should show you how to prepare and inject Idacio correctly using the kit with
vial before using it for the first time. Contact your doctor if you have any questions.

Note: images are for illustrative purposes only
Read all the instructions carefully before using Idacio vial kit.
Important information
Use Idacio Vial Kit only if the healthcare professional has instructed you on how to use it
correctly.
Idacio Vial Kit is for single use.
Children are not allowed to self-inject and the injection must be administered by a
trained adult.
Keep Idacio Vial Kit and the container for special waste disposal out of the reach and sight of children.

Do notshake the syringe or the vial.
Shaking may cause damage.
Contact your healthcare professional or pharmacist if you have any questions or need support.

Storage information
Store Idacio Vial Kit in its original packaging to protect it from light.
Store Idacio Vial Kit in a refrigerator between 2°C and 8°C.
If necessary, for example when travelling, Idacio Vial Kit can be stored at
room temperature for up to 28 days.

Step 1 Take the package and check for damage

• 1.1Remove Idacio Vial Kit from the refrigerator.

• 1.2Leave the kit at room temperature for at least 30 minutes to allow the medicine to warm up. Injecting a cold medicine can be painful.

Warning:Do notheat the kit in any other way such as in the microwave, in hot water, or in direct sunlight.

• 1.3Open the kit and place all the components on a clean, dry, flat surface. Check the components to make sure the packaging and contents are not damaged.

Vial Vial adapter

Alcohol swabs

Needle

Syringe

Warning: Do notuse if damaged.

• 1.4You will also need the following components that are not included in the kit: a clean cotton swab or gauze, and a container for special waste (see section 7.2). Open the special waste container so it is ready for use.

• 1.5Check the diary for injection dates and injection sites to understand the injection site for this administration.

Step 2 Prepare the vial

• 2.1Wash your hands thoroughly with soap and water and dry them.

Warning:gloves do not replace the need to wash your hands.

• 2.2Check the label on the vial for Idacio and the expiration date.

Warning:Do notuse the vial if:
the name on the vial is not Idacio.
The expiration date on the vial has passed.

• 2.3Check the liquid to make sure that: The solution is clear, colorless and free of particles.

Warning:Do notuse the vial if the solution is cloudy, colored or contains particles or
flocculi.

• 2.4Gently remove the yellow cap from the vial.

• 2.5Clean the top of the vial with an alcohol swab and discard the swab.

Warning:Do nottouch the top of the vial after cleaning it.

• 2.6Peel off the paper from the vial adapter packaging without removing the vial adapter from its packaging.

Warning:Do nottouch the vial adapter.

• 2.7With the vial adapter still in its packaging, press the vial adapter onto the top of the vial until it clicks into place.

• 2.8Hold the vial firmly and lift off the packaging. To ensure the adapter remains on top of the vial, hold the packaging by the outer edge.

Step 3 Prepare the syringe
Plunger

Plunger Graduated part Syringe

• 3.1Open the syringe packaging and grasp the syringe by the graduated part.

Warning:Do nottouch the tip of the syringe.

• 3.2Holding the vial adapter firmly, insert the end of the syringe into the adapter and screw it on to connect it.

• 3.3Turn the vial upside down so that it is vertical with the syringe still attached.

• 3.4Holding the vial and syringe firmly in a vertical position, slowly draw up the prescribed dose.

Warning:If the plunger has been pulled out completely, discard the syringe.

Do nottry to reinsert it but use a new kit.

• 3.5Slowly push the plunger all the way down to push the medicine back into the vial. This is to eliminate any air or bubbles.

Again, slowly push the plunger to the prescribed dose and stop.
If you still see empty spaces with air or bubbles at the end of the syringe, repeat this step until the
air or bubbles are gone. Do notshake the syringe.

Warning:Do notuse the syringe if it contains a large amount of air.

• 3.6Turn the vial and syringe over, hold the vial adapter firmly and unscrew the syringe from the vial adapter.

• 3.7Place the syringe on a clean, flat surface. Warning:Do nottouch the end of the syringe. Warning:Do notthrow the vial away.

Step 4 Prepare the needle
Safety guard
Finger support structure
Connector
for the
syringe
yellow

Stopper Needle

• 4.1Open the needle packaging to expose the yellow syringe connector.

Warning:Do notremove the needle from the packaging.

Warning:Do nottouch the yellow connector.

• 4.2Insert the end of the syringe into the yellow syringe connector and screw it on to connect it.

• 4.3Pull off the needle packaging. Warning: Do notremove the transparent cap from the needle.
• 4.4Pull back the pink safety cover of the needle towards the syringe.

Warning:Do notdetach the pink safety cover from the yellow connector.

• 4.5Place the syringe on a clean, flat surface.

Step 5 Prepare the injection

• 5.1Choose an injection site: on the upper thighs or on the lower abdomen (inject at least 5 centimeters from the navel).

Choose a different injection site each time (at least 2.5 centimeters away from the previous injection site) to reduce redness, irritation or other skin problems.

Warning:Do notinject into an area that is sore, bruised, red, hardened, scarred or where you have
stretch marks.

• 5.2Clean the injection site with an alcohol swab and discard the swab.

Warning:Do notblow or touch the injection site after cleaning it.

• 5.3Remove the transparent cap from the needle by pulling it straight up and discard it.

Warning:Do nottry to put the cap back on the needle.

• 5.4Hold the syringe like a pen with the pink safety cover of the needle facing upwards.

Step 6 Give the injection

• 6.1With the other hand, gently pinch a fold of clean skin and hold it pinched.

Warning:Do nottouch where you intend to inject.

• 6.2With a quick, short movement, push the needle into the skin at a 45° angle.

Note:With experience, you will find the angle (between 45° and 90°) that is most suitable for you and the child.

• 6.3Gently press the plunger all the way down until the syringe is empty.

• 6.4Remove the needle from the skin, being careful to pull it out at the same angle it was inserted. Then release the pinched skin.
• 6.5Center your thumb or index finger on the finger support structure and push forward towards the needle the safety cover until you feel it click closed.

• 6.6The needle is now covered and safe. It can be discarded in the special waste container. Warning:Contact your healthcare provider if you did not inject the full dose.
• 6.7If there is blood or fluid at the injection site, gently press a clean cotton ball or gauze onto the skin for 10 seconds.

Warning:Do notrub the injection site.

Step 7 Record the injection and dispose of the components

• 7.1Now that you have completed the injection, update the diary with: the injection site, the date, any problems encountered, and the lot number (on the vial label).

• 7.2Dispose of the used syringe with the needle protected and the vial with the adapter attached in a special waste container.

Warning:Keep the special waste container out of the reach of children.

Warning:Do notkeep any used medication.

Warning:Do notthrow the syringe or vial in the household trash.
If you do not have a special waste container, you can use a household waste container that:
is made of durable plastic;
can be closed with a tight and puncture-resistant lid;
keeps the special waste inside;
is upright and stable during use;
is leak-proof;
is correctly labeled to warn of the presence of special waste inside.

• 7.3When the special waste container is almost full, you will need to follow local guidelines for the proper disposal of special waste containers. Warning: Do notrecycle the special waste container.