Humira 20 mg solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Humira 20mg solution for injection in pre-filled syringe

adalimumab

Read the entire leaflet carefully before your child starts using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. Your doctor will provide you with a patient information card containing important safety information you need to know before and during your child's treatment with Humira. Keep this patient information card in your or your child's possession.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only and must not be given to other people, even if they have the same symptoms as your child, since it may harm them.
• If your child experiences any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Humira is and what it is used for

Humira contains the active substance adalimumab.

Humira is indicated for the treatment of the following inflammatory diseases:

• Polyarticular juvenile idiopathic arthritis
• Enthesitis-related arthritis
• Pediatric plaque psoriasis
• Pediatric Crohn's disease
• Pediatric uveitis

The active substance in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that target a specific site.

Adalimumab targets a protein called tumor necrosis factor (TNFα), which plays a role in the immune (defence) system and is found at elevated levels in the inflammatory diseases described above. By targeting TNFα, Humira reduces the inflammatory process in these diseases.

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood.

Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. Your child may have first received other disease-modifying drugs, such as methotrexate. If these medications have not responded adequately, your child will be given Humira to treat their juvenile idiopathic arthritis.

Your doctor will decide whether Humira should be used with methotrexate or alone.

Enthesitis-related arthritis

Enthesitis-related arthritis is an inflammatory disease affecting the joints and the sites where tendons attach to bones.

Humira is used to treat enthesitis-related arthritis in patients from 6 years of age. Your child may have first received other disease-modifying drugs, such as methotrexate. If these medications have not responded adequately, your child will be given Humira to treat their enthesitis-related arthritis.

Pediatric plaque psoriasis

Plaque psoriasis is a skin disease that causes red, scaly, crusted areas covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift from the nail bed, which may be painful. Psoriasis is believed to be caused by a defect in the body's immune system that leads to increased production of skin cells.

Humira is used to treat chronic severe plaque psoriasis in children and adolescents aged 4 to 17 years who have not responded to, or are not suitable candidates for, topical therapy and phototherapy.

Pediatric Crohn's disease

Crohn's disease is an inflammatory disease of the gastrointestinal tract.

Humira is used to treat moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.

Your child may have first received other medications. If these have not responded adequately, your child will be given Humira to reduce the signs and symptoms of their disease.

Pediatric uveitis

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Humira is used to treat children aged 2 years and older with chronic non-infectious uveitis involving inflammation of the front part of the eye.

This inflammation may lead to decreased vision and/or the presence of floaters in the eye (black spots or thin lines moving across the field of vision). Humira works by reducing this inflammation.

Your child may have first received other medications. If these have not responded adequately, your child will be given Humira to reduce the signs and symptoms of their disease.

2. What you need to know before your child starts using Humira

Do not use Humira:

• If your child is allergic to adalimumab or to any of the other components of this medicine (listed in section 6).

• If your child has active tuberculosis or another serious infection (see "Warnings and precautions"). If your child has symptoms of infection, such as fever, wounds, fatigue, or dental problems, it is important to inform your doctor.

• If your child has moderate or severe heart failure. It is important to tell your doctor if your child has had or currently has any serious heart problems (see "Warnings and precautions").

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Humira.

Allergic reactions

• If you notice an allergic reaction in your child with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or rash, stop administering Humira and contact your doctor immediately, as in rare cases these reactions may be life-threatening.

Infections

• If your child has an infection, including chronic or localized infections (for example: a leg ulcer), consult your doctor before starting treatment with Humira. If you are unsure, contact your doctor.

• While being treated with Humira, your child may be more likely to develop infections. This risk may be higher if your child has lung damage. These infections can be serious and include:

  • tuberculosis
  • infections caused by viruses, fungi, parasites, or bacteria
  • serious blood infection (sepsis)

In rare cases, these infections may be life-threatening. Therefore, it is important to inform your doctor if your child develops symptoms such as fever, wounds, fatigue, or dental problems. Your doctor may recommend temporarily stopping Humira treatment.

• Inform your doctor if your child lives in or travels to regions where fungal infections (for example, histoplasmosis, coccidioidomycosis, or blastomycosis) are common.

• Inform your doctor if your child has had recurrent infections or other factors that increase the risk of infections.

• Your child and doctor should pay special attention to signs of infection while your child is being treated with Humira. It is important to inform your doctor if your child develops symptoms such as fever, wounds, fatigue, or dental problems.

Tuberculosis

• Cases of tuberculosis have been reported in patients treated with Humira. Before starting treatment, your doctor will check your child for signs and symptoms of tuberculosis. This includes a thorough medical evaluation including your child's medical history and appropriate screening tests (for example, chest X-ray and tuberculin skin test). The results and actions taken should be recorded on your child's patient information card.

• It is very important to tell your doctor if your child has ever had tuberculosis or has been in close contact with someone who had tuberculosis. If your child has active tuberculosis, do not use Humira.

• Tuberculosis may develop during treatment even if your child has received preventive treatment for tuberculosis.

• Inform your doctor immediately if symptoms of tuberculosis (for example, persistent cough, weight loss, lack of energy, low-grade fever) or any other infection appear during or after treatment.

Hepatitis B

• Inform your doctor if your child is a carrier of the hepatitis B virus (HBV), has had active HBV infection, or if you think your child may be at risk of contracting HBV.
  • Your doctor should perform a test for HBV. Humira can cause reactivation of the virus in people who carry HBV.
  • In rare cases, especially if your child is taking other medicines that suppress the immune system, HBV reactivation can be life-threatening.

Surgery or dental procedures

• If your child is scheduled for surgery or a dental procedure, please inform your doctor that your child is taking Humira. Your doctor may recommend temporarily stopping Humira treatment.

Demyelinating disease

• If your child has or develops a demyelinating disease (a disease affecting the protective covering around nerves, such as multiple sclerosis), your doctor will decide whether your child should start or continue Humira treatment. Inform your doctor immediately if your child experiences symptoms such as changes in vision, weakness in arms or legs, or numbness or tingling anywhere in the body.

Vaccines

• Certain vaccines may cause infections and should not be given while your child is being treated with Humira.

• Talk to your doctor before your child receives any vaccine.

• If possible, it is recommended that children receive all age-appropriate vaccines before starting Humira treatment.

• If your daughter received Humira while pregnant, her baby may have an increased risk of infections for about five months after the last dose of Humira received during pregnancy. It is important to inform the pediatrician and other healthcare professionals about your daughter's use of Humira during pregnancy so they can decide whether the baby should receive any vaccines.

Heart failure

• If your child has mild heart failure and is being treated with Humira, your doctor may monitor your child closely. It is important to tell your doctor if your child has had or currently has serious heart problems. If your child develops new symptoms or existing symptoms worsen (such as shortness of breath or swelling in the feet), contact your doctor immediately. Your doctor will decide whether Humira should be continued.

Fever, bruising, bleeding, or pale appearance

• In some patients, the body may be unable to produce enough of certain blood cells that help fight infections or help stop bleeding. Your doctor may decide to stop treatment. If your child develops persistent fever, easy bruising, bleeding easily, or looks pale, contact your doctor immediately.

Cancer

• Very rarely, certain types of cancer have been reported in children and adults treated with Humira or other TNF blockers.

• People with more severe rheumatoid arthritis or with long-standing disease may have a higher than average risk of developing lymphoma (a cancer affecting the lymphatic system) and leukemia (a cancer affecting blood and bone marrow).

• If your child is being treated with Humira, the risk of developing lymphoma, leukemia, and other cancers may increase. A rare but serious type of lymphoma has been observed in some patients receiving Humira. Some of these patients were also receiving azathioprine or 6-mercaptopurine.

• Inform your doctor if your child is taking azathioprine or 6-mercaptopurine with Humira.

• Cases of non-melanoma skin cancer have been observed in patients using Humira.

• Inform your doctor if new skin lesions appear during or after treatment, or if existing lesions change in appearance.

• Cancers other than lymphoma have been reported in patients with a specific lung disease called Chronic Obstructive Pulmonary Disease (COPD) who were treated with another TNF blocker. If your child has COPD or is a heavy smoker, consult your doctor to determine whether treatment with a TNF blocker is appropriate for your child.

Autoimmune disease

• Rarely, treatment with Humira may cause a lupus-like syndrome. Contact your doctor if your child develops symptoms such as a persistent unexplained rash, fever, joint pain, or fatigue.

Use of Humira with other medicines

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.

Your child should not take Humira with other medicines containing the following active substances due to an increased risk of serious infections:

• anakinra
• abatacept

Humira may be used together with:

• methotrexate
• certain disease-modifying antirheumatic drugs (for example, sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold salts)
• corticosteroids or pain medicines, including non-steroidal anti-inflammatory drugs (NSAIDs).

If you have any doubts, please consult your doctor.

Pregnancy and breastfeeding

• Your daughter should consider using appropriate contraceptive methods to avoid becoming pregnant and continue using them for at least 5 months after the last Humira treatment.
• If your daughter is pregnant, thinks she might be pregnant, or plans to have a baby, consult her doctor about using this medicine.
• Humira should be used during pregnancy only if clearly needed.
• According to a pregnancy study, there was no increased risk of birth defects when mothers received Humira during pregnancy compared to mothers with the same disease who did not receive Humira.
• Humira may be used during breastfeeding.
• If your daughter used Humira during pregnancy, her baby may have a higher risk of infection.
• It is important to inform the pediatrician or other healthcare professionals that your daughter used Humira during pregnancy before the baby receives any vaccines. For more information on vaccines, see the section "Warnings and precautions".

Driving and using machines

The effect of Humira on your child's ability to drive, ride a bicycle, or operate machinery is minimal. Dizziness and vision disturbances may occur after using Humira.

Humira contains polysorbate

This medicine contains 0.2 mg of polysorbate 80 in each 20 mg dose. Polysorbates may cause allergic reactions. Inform your doctor if your child has any known allergies.

3. How to use Humira

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended doses of Humira for each of the approved uses are shown in the following table. Your doctor may prescribe a different dose of Humira if your child requires a different dose.

Juvenile idiopathic polyarticular arthritis
Age or body weight	How much and how often to take	Notes
Children, adolescents, and adults from 2 years of age weighing 30 kg or more	40 mg every other week	Not applicable
Children and adolescents from 2 years of age weighing between 10 kg and 30 kg	20 mg every other week	Not applicable

Enthesitis-Associated Arthritis
Age or body weight	How much and how often to take	Notes
Children, adolescents, and adults from 6 years of age weighing 30 kg or more	40 mg every other week	Not applicable
Children and adolescents from 6 years of age weighing between 15 kg and 30 kg	20 mg every other week	Not applicable

Pediatric plaque psoriasis
Age or body weight	How much and how often to take	Notes
Children and adolescents from 4 to 17 years of age weighing 30 kg or more	The initial dose is 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.	Not applicable
Children and adolescents from 4 to 17 years of age weighing at least 15 kg up to 30 kg	The initial dose is 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week.	Not applicable

Pediatric Crohn's disease
Age or body weight	How much and how often to take	Notes
Children and adolescents from 6 to 17 years of age weighing 40 kg or more	The initial dose is 80 mg, followed by 40 mg two weeks later. If a more rapid response is needed, your pediatrician may prescribe an initial dose of 160 mg followed by 80 mg two weeks later. After that, the usual dose is 40 mg every other week.	Your pediatrician may increase the dose to 40 mg weekly or 80 mg every two weeks.
Children and adolescents from 6 to 17 years of age weighing less than 40 kg	The initial dose is 40 mg, followed by 20 mg two weeks later. If a more rapid response is needed, your doctor may prescribe an initial dose of 80 mg, followed by 40 mg two weeks later. After that, the usual dose is 20 mg every other week.	Your pediatrician may increase the dosing frequency to 20 mg weekly.

Pediatric uveitis
Age or body weight	How much and how often to take	Notes
Children and adolescents aged 2 years and older weighing less than 30 kg	20 mg every other week	Your doctor may prescribe an initial dose of 40 mg, which may be given one week before starting the usual regimen of 20 mg every other week. Use of Humira in combination with methotrexate is recommended.
Children and adolescents aged 2 years and older weighing at least 30 kg	40 mg every other week	Your doctor may prescribe an initial dose of 80 mg, which may be given one week before starting the usual regimen of 40 mg every other week. Use of Humira in combination with methotrexate is recommended.

Form and route of administration

Humira is injected under the skin (by subcutaneous injection).

Instructions for administering a Humira injection can be found in section 7, “How to inject Humira”.

If you use more Humira than you should

If Humira is accidentally injected more frequently than prescribed by your doctor or pharmacist, you must contact your doctor or pharmacist and inform them that your child has used more than the prescribed amount. Always keep the medicine carton with you, even if it is empty.

If you forget to use Humira

If you forget to give your child an injection, administer the next Humira dose as soon as you remember. Then give the following dose as usual, as if no dose had been missed.

If you stop using Humira

The decision to discontinue treatment with Humira should be discussed with your doctor. Your child's symptoms may return after stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most adverse effects are mild to moderate. However, some may be serious and require treatment. Adverse effects may occur as late as at least 4 months after the last injection of Humira.

Contact your doctor immediately if you notice any of the following

• severe rash, hives, or other signs of allergic reaction
• swelling of the face, hands, or feet
• difficulty breathing or swallowing
• shortness of breath during exercise or when lying down, swelling of the feet

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

• signs of infection such as fever, nausea, wounds, dental problems, burning sensation when urinating
• feeling weak or tired
• cough
• tingling
• numbness
• double vision
• weakness in arms or legs
• a lump or open wound that does not heal
• signs and symptoms of blood disorders such as persistent fever, bruising, bleeding, and paleness

The symptoms described above may be signs of the adverse effects listed below, which have been observed with Humira.

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

• injection site reactions (including pain, swelling, redness, or itching)
• lower respiratory tract infections (including cold, runny nose, sinusitis, pneumonia)
• headache
• abdominal pain
• nausea and vomiting
• 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)
• ear infection
• oral infections (including dental infection and cold sores)
• infections in the reproductive system
• urinary tract infection
• fungal infections
• joint infections
• benign tumors
• skin cancer
• allergic reactions (including seasonal allergies)
• dehydration
• mood changes (including depression)
• anxiety
• difficulty sleeping
• sensory disturbances such as tingling, burning, or numbness
• migraine
• nerve root compression (including lower back and leg pain)
• visual disturbances
• eye inflammation
• eyelid inflammation and eye swelling
• dizziness (sensation of spinning or lightheadedness)
• sensation of rapid heartbeat
• high blood pressure
• flushing
• hematoma (accumulation of blood outside blood vessels)
• cough
• asthma
• difficulty breathing
• gastrointestinal bleeding
• dyspepsia (indigestion, bloating, and heartburn)
• acid reflux
• dry eye syndrome (including dry eyes and mouth)
• itching
• itchy rash
• bruising
• skin inflammation (such as eczema)
• nail splitting in hands and feet
• increased sweating
• hair loss
• new-onset psoriasis or worsening of existing psoriasis
• muscle spasms
• blood in urine
• kidney problems
• chest pain
• edema (swelling)
• fever
• decreased platelet count in blood, increasing the risk of bleeding or bruising
• impaired wound healing

Uncommon (may affect up to 1 in 100 people)

• opportunistic infections (including tuberculosis and other infections that occur when disease resistance is reduced)
• neurological infections (including viral meningitis)
• eye infections
• bacterial infections
• diverticulitis (inflammation and infection of the large intestine)
• cancer
• cancer affecting the lymphatic system
• melanoma
• immune-mediated disorders that may affect the lungs, skin, and lymph nodes (most commonly presenting as sarcoidosis)
• vasculitis (inflammation of blood vessels)
• tremor (feeling shaky)
• neuropathy (nerve disorder)
• stroke
• hearing loss, tinnitus
• sensation of irregular heartbeat such as palpitations
• heart problems that may cause shortness of breath or swollen ankles
• heart attack
• aneurysm (bulging in the wall of a major artery), venous inflammation and clotting, blood vessel blockage
• lung diseases that may cause difficulty breathing (including inflammation)
• pulmonary embolism (blockage of an artery in the lung)
• pleural effusion (abnormal fluid accumulation in the pleural space)
• pancreatitis (inflammation of the pancreas) causing severe abdominal and back pain
• difficulty swallowing
• facial edema (swelling of the face)
• gallbladder inflammation, gallstones
• fatty liver
• night sweats
• scarring
• abnormal muscle spasms
• systemic lupus erythematosus (including inflammation of the skin, heart, lungs, joints, and other organs)
• sleep disturbances
• impotence
• inflammations

Rare (may affect up to 1 in 1000 people)

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

Frequency not known (cannot be estimated from available data)

• hepatosplenic T-cell lymphoma (a rare and often fatal blood cancer)
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi's sarcoma, an uncommon cancer associated with human herpesvirus 8 infection. Kaposi's sarcoma usually presents more frequently as purplish skin lesions
• liver failure
• worsening of a condition called dermatomyositis (seen as skin rash accompanied by muscle weakness)
• weight gain (in most patients, weight gain was minimal)

Some adverse effects observed in clinical trials do not cause symptoms and can only be detected through blood tests. These include:

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

• low blood count of white blood cells
• low blood count of red blood cells
• increased blood lipids
• increased liver enzymes

Common (may affect up to 1 in 10 people)

• high blood count of white blood cells
• low blood count of platelets
• increased blood uric acid
• abnormal blood sodium levels
• low blood calcium
• low blood phosphate
• high blood sugar
• elevated lactate dehydrogenase levels in blood
• presence of autoantibodies in blood
• low blood potassium

Uncommon (may affect up to 1 in 100 people)

• elevated bilirubin levels (liver function test)

Rare (may affect up to 1 in 1000 people)

• low blood counts of white blood cells, red blood cells, and platelets

Reporting of adverse effects

If your child experiences any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Humira

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label/blister pack/carton after "EXP".

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Keep the pre-filled syringe in its outer packaging to protect it from light.

Alternative storage:

When necessary (for example, when traveling), a single pre-filled syringe of Humira may be stored at room temperature (up to 25°C) for a maximum period of 14 days—ensure it is protected from light. Once the syringe has been removed from the refrigerator for storage at room temperature, it must be used within the following 14 days or discarded, even if it is returned to the refrigerator.

You should record the date on which the syringe was removed from the refrigerator, and the date after which the syringe must be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Humira

The active substance is adalimumab.

The other components are mannitol, polysorbate 80, and water for injections.

Appearance of the medicinal product and contents of the pack

Humira 20 mg solution for injection in a pre-filled syringe for paediatric use is supplied as a sterile solution containing 20 mg of adalimumab dissolved in 0.2 ml of solution.

The Humira pre-filled syringe is a glass syringe containing a solution of adalimumab.

The Humira pre-filled syringe is available in a pack containing 2 pre-filled syringes with 2 alcohol swabs.

Humira is also available in vial, pre-filled syringe, and/or pre-filled pen presentations.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer responsible for manufacturing

AbbVie Biotechnology GmbH

Knollstrasse

67061 Ludwigshafen

Germany

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder.

Belgium/Belgium/Belgium AbbVie SA Tel/Tel: +32 10 477811	Lithuania AbbVie UAB Tel: +370 5 205 3023
	Luxembourg/Luxembourg AbbVie SA Belgium/Belgium Tel/Tel: +32 10 477811
Czech Republic AbbVie s.r.o. Tel: +420 233 098 111	Hungary AbbVie Kft. Tel.: +36 1 455 8600
Denmark AbbVie A/S Tlf.: +45 72 30-20-28	Malta V.J.Salomone Pharma Limited Tel: +356 21220174
Germany AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (free of charge) Tel: +49 (0) 611 / 1720-0	Netherlands AbbVie B.V. Tel: +31 (0)88 322 2843
Estonia AbbVie OÜ Tel: +372 623 1011	Norway AbbVie AS Tlf: +47 67 81 80 00
Greece AbbVie PHARMACEUTICAL S.A. Tel: +30 214 4165 555	Austria AbbVie GmbH Tel: +43 1 20589-0
Spain AbbVie Spain, S.L.U. Tel: +34 91 384 09 10	Poland AbbVie Polska Sp. z o.o. Tel.: +48 22 372 78 00
France AbbVie Tél: +33 (0) 1 45 60 13 00	Portugal AbbVie, Lda. Tel: +351 (0)21 1908400
Croatia AbbVie d.o.o. Tel +385 (0)1 5625 501	Romania AbbVie S.R.L. Tel: +40 21 529 30 35
Ireland AbbVie Limited Tel: +353 (0)1 4287900	Slovenia AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060
Iceland Vistor Tel: +354 535 7000	Slovakia AbbVie s.r.o. Tel: +421 2 5050 0777
Italy AbbVie S.r.l. Tel: +39 06 928921	Finland AbbVie Oy Puh/Tel: +358 (0) 10 2411 200
Cyprus Lifepharma (Z.A.M.) Ltd Tel.: +357 22 34 74 40	Sweden AbbVie AB Tel: +46 (0)8 684 44 600
Latvia AbbVie SIA Tel: +371 67605000

Date of the most recent review of this leaflet

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

To listen to or request a copy of this leaflet in braille, large print, or audio, please contact the local representative of the marketing authorization holder.

7. How to inject Humira

• The following instructions explain how to inject Humira subcutaneously to your child using the pre-filled syringe. Read all instructions carefully first, then follow them step by step.

• Your doctor, nurse, or pharmacist will show you the injection technique.

• Do not attempt to give your child the injection until you are certain you understand how to prepare and administer the injection.

• After proper training, your child or another person, such as a family member or friend, may administer the injection.

• Use each pre-filled syringe only once for a single injection.

Humira Pre-filled Syringe

Plunger
Gripping wings
Needle cap

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

• the liquid is cloudy, discolored, or contains flakes or particles
• the expiry date (EXP) has passed
• the liquid has been frozen or exposed to direct sunlight
• the pre-filled syringe has been dropped or crushed

Do not remove the needle cap until immediately before injection. Keep Humira out of the sight and reach of children.

STEP 1 Remove Humira from the refrigerator. Allow Humira to reach room temperature for 15 to 30 minutes before injection. Do not remove the needle cap while allowing Humira to reach room temperature Do not warm Humira in any other way. For example, do not heat it in a microwave or in hot water
STEP 2 Syringe Alcohol wipe	Check the expiration date (EXP). Do not use the prefilled syringe if the expiration date (EXP) has passed. On a clean, flat surface, place 1 single-use prefilled syringe and 1 alcohol wipe Wash your hands and dry them.
STEP 3 Injection sites Injection sites	Choose an injection site on your child's body: on the front of your child's thighs or on your child's stomach (abdomen), at least 5 cm away from the navel at least 3 cm away from the previous injection site Clean the injection site with the alcohol wipe using circular motions. Do not inject through clothing Do not inject into irritated, bruised, red, hard, scarred, or striated skin, or areas with psoriatic plaques
STEP 4	Hold the prefilled syringe in one hand. Inspect the liquid in the prefilled syringe. Ensure the liquid is clear and colorless Do not use the prefilled syringe if the liquid is cloudy or contains particles Do not use the prefilled syringe if it has been dropped or damaged Carefully remove the needle cap with the other hand. Discard the needle cap and do not reuse it. Do not touch the needle with your fingers or allow it to come into contact with any surface
STEP 5	Hold the prefilled syringe with the needle pointing upward. Hold the syringe at eye level with one hand to see any air bubbles Slowly push the plunger to expel air through the needle. It is normal to see a few drops of liquid coming out from the needle
STEP 6	Hold the body of the prefilled syringe between your thumb and index finger with one hand, as if holding a pen. With your other hand, pinch the skin at the injection site to lift it and hold it firmly.
STEP 7	Insert the needle fully into the skin at an approximate angle of 45 degrees with a short, quick motion. Once the needle is under the skin, release the skin pinch Slowly push the plunger all the way down until all the liquid is injected and the prefilled syringe is empty.
STEP 8 Cotton ball	Once the injection is complete, slowly remove the needle from the skin while keeping the prefilled syringe at the same angle. After completing the injection, place a cotton ball or gauze over the injection site. Do not rub the area Minor bleeding at the injection site is normal
STEP 9 Dispose of the prefilled syringe in a sharps container as instructed by your doctor, nurse, or pharmacist. Never recap a needle. Do not recycle or dispose of the prefilled syringe in household trash Always keep the prefilled syringe and sharps container out of sight and reach of children The needle cap, alcohol wipe, cotton ball or gauze, blister pack, and packaging may be disposed of in household trash.