Patient Information Leaflet: Information for the Patient

Humira 20 mg pre-filled syringe injectable solution

adalimumab

Read this 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 give you aPatient Information Leaflet, which contains important safety information that you need to know before and during your child's treatment with Humira. Keep, you or your child, thisPatient Information Leaflet.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for your child and should not be given to other people, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Humira is and what it is used for

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

3.How to use Humira

4.Possible side effects

5.Storage of Humira

6.Contents of the pack and additional information

7.How to inject Humira

Humira contains adalimumab as its active substance

Humira is indicated for the treatment of the inflammatory diseases described below:

• Polyarticular idiopathic juvenile arthritis
• Arthritis associated with enthesitis
• Pediatric plaque psoriasis
• Pediatric Crohn's disease
• Pediatric uveitis

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

The target of adalimumab is a protein called tumor necrosis factor-alpha (TNFα), which is involved in the immune system (defense) and is found at elevated levels in the inflammatory diseases described above. By targeting TNFα, Humira reduces the inflammatory process in those diseases.

Polyarticular idiopathic juvenile arthritis

Polyarticular idiopathic juvenile arthritis is an inflammatory joint disease that usually appears for the first time in childhood.

Humira is used to treat polyarticular idiopathic juvenile arthritis in patients aged 2 years and older. Your child may have received other disease-modifying drugs, such as methotrexate, first. If those medications do not respond well enough, your child will receive Humira to treat their arthritis.

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

Arthritis associated with enthesitis

Arthritis associated with enthesitis is an inflammatory joint disease and a condition where tendons attach to bones.

Humira is used to treat arthritis associated with enthesitis in patients aged 6 years and older. Your child may have received other disease-modifying drugs, such as methotrexate, first. If these medications do not respond well enough, your child will receive Humira to treat their arthritis associated with enthesitis.

Pediatric plaque psoriasis

Pediatric plaque psoriasis is a skin disease that causes red, scaly, crusty areas covered with silver scales. Plaque psoriasis can also affect the nails, causing them to deteriorate, thicken, and lift from the nail bed, which can be painful.It is believed that psoriasis is caused by a defect in the body's immune system that leads to an increase in skin cell production.

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

Pediatric Crohn's disease

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

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

Your child may have received other medications first. If these medications do not respond well enough, your child will receive Humira to reduce the symptoms and signs of their disease.

Pediatric uveitis

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

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

This inflammation can lead to vision loss and/or the presence of spots in the eye (black dots or thin lines that move across the field of vision). Humira acts by reducing this inflammation.

Your child may have received other medications first. If these medications do not respond well enough, your child will receive Humira to reduce the symptoms and signs of their disease.

No use Humira:

• If your child is allergic to adalimumab or any of the other components of this medication (including those 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, dental problems, please inform your doctor.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Humira.

Allergic reactions

• If you notice in your child an allergic reaction with symptoms such as chest tightness, difficulty breathing, dizziness, swelling, or hives, discontinue the administration of Humira and contact your doctor immediately, as in rare cases, these reactions can be life-threatening.

Infections

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

• Your child may be more susceptible to infections while taking Humira. This risk may be higher if they have lung damage. These infections can be serious and include:
• • tuberculosis
  • infections caused by viruses, fungi, parasites, or bacteria
  • severe blood infection (sepsis)

In rare cases, these infections can be life-threatening. For this reason, it is essential to inform your doctor if your child has symptoms such as fever, wounds, fatigue, or dental problems. Your doctor may recommend temporarily discontinuing Humira treatment.

• Inform your doctor if your child lives 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 their doctor should pay special attention to signs of infection while your child is being treated with Humira. It is essential to inform your doctor if your child has symptoms such as fever, wounds, fatigue, or dental problems.

Tuberculosis

• As cases of tuberculosis have been reported in patients treated with Humira, before starting treatment with Humira, your doctor will check for signs and symptoms of tuberculosis in your child. This will include a comprehensive medical evaluation, including your child's medical history and appropriate screening tests (for example, chest X-ray and tuberculin test). The results of these tests should be recorded in your child'spatient information card.

Hepatitis B

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

Surgery or dental intervention

• If your child is scheduled for surgery or dental intervention, please inform your doctor that they are taking Humira. Your doctor may recommend temporarily discontinuing Humira treatment.

Autoimmune disease

• In rare cases, treatment with Humira may lead to a condition similar to lupus. Contact your doctor if your child has symptoms such as persistent rash without explanation, fever, joint pain, or fatigue.

Using Humira with other medications

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

Your child should not take Humira with other medications that contain the following active ingredients due to an increased risk of serious infections:

• anakinra
• abatacept.

Humira can be taken with:

• methotrexate
• certain disease-modifying antirheumatic drugs (for example, sulfasalazine, hydroxychloroquine, leflunomide, and injectable gold preparations)
• steroids or pain medications, including nonsteroidal anti-inflammatory drugs (NSAIDs).

If you have any doubts, please consult your doctor.

Pregnancy and breastfeeding

• Your daughter should consider using suitable contraceptive methods to avoid pregnancy and continue using them for at least 5 months after the last Humira treatment.
• If your daughter is pregnant, thinks she may be pregnant, or intends to become pregnant, consult your doctor about the use of this medication.
• Humira should only be used during pregnancy if necessary.
• According to a study in pregnancy, there was no increased risk of congenital defects when the mother had received Humira treatment during pregnancy compared to mothers with the same disease who did not receive Humira treatment.
• Humira can be used during breastfeeding.
• If your daughter used Humira during pregnancy, her baby may have a higher risk of contracting an infection.
• It is essential to inform the pediatrician or other healthcare professionals that your daughter uses Humira during pregnancy before the baby receives any vaccine. For more information on vaccines, see the "Warnings and precautions" section.

Conducting and using machines

The influence of Humira on your child's ability to drive, ride a bike, or use machines is small. They may experience a sensation of the room spinning and visual disturbances after using Humira.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of 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 needs a different dose.

Form and route of administration

Humira is injected under the skin (subcutaneously).

See the instructions for administering a Humira injection in Section 7 “How to inject Humira”.

Using more Humira than prescribed

If you accidentally inject Humira more frequently than prescribed by your doctor or pharmacist, you should call your doctor or pharmacist and tell them that your child has used more. Always carry the medication box with you, even if it is empty.

Missing a dose

If you forget to administer a dose, inject the next dose of Humira as soon as you remember. Then, administer the next dose as usual, as if you had not forgotten a dose.

Stopping treatment with Humira

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

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 can appear at least up to 4 months after the last injection of Humira.

Get in touch with your doctor immediately if you notice any of the following side effects

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

Get in touch with your doctor as soon as possible if you notice any of the following side effects

• signs of infection such as fever, nausea, wounds, dental problems, burning sensation when urinating
• feeling of weakness or fatigue
• 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, rashes, bleeding, and pallor

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

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

• reactions at the injection site (including pain, swelling, redness, or itching)
• lower respiratory tract infections (including colds, coughing, sinusitis, pneumonia)
• headache
• abdominal pain
• nausea and vomiting
• pruritus
• muscle pain

Common(may affect up to 1 in 10 people)

• serious infections (including sepsis and influenza)
• gastrointestinal infections (including gastroenteritis)
• skin infections (including cellulitis and herpes)
• ear infection
• oral infections (including dental infection and cold sore)
• reproductive system infections
• urinary tract infections
• fungus infections
• joint infections
• benign tumors
• skin cancer
• allergic reactions (including seasonal allergy)
• dehydration
• mood changes (including depression)
• anxiety
• difficulty sleeping
• sensorial alterations such as tingling, itching, or numbness
• migraine
• nerve root compression (including lower back and leg pain)
• visual disturbances
• eye inflammation
• eyelid inflammation and swelling of the eye
• dizziness (feeling of spinning or dizziness)
• rapid pulse
• high blood pressure
• flushing
• hematoma (accumulation of blood outside of blood vessels)
• cough
• asthma
• difficulty breathing
• gastrointestinal bleeding
• indigestion, bloating, and heartburn
• acid reflux
• dry eye syndrome (including dryness in eyes and mouth)
• itching
• pruritus with itching
• bruises
• skin inflammation (such as eczema)
• rotting of fingernails and toenails
• excessive sweating
• hair loss
• new onset or worsening of existing psoriasis
• muscle spasms
• blood in urine
• kidney problems
• chest pain
• swelling (edema)
• fever
• decreased platelet count in blood, increasing the risk of bleeding or bruising
• wound healing problems

Uncommon(may affect up to 1 in 100 people)

• opportunistic infections (including tuberculosis and other infections that occur when resistance to disease decreases)
• neurological infections (including viral meningitis)
• eye infections
• bacterial infections
• diverticulitis (inflammation and infection of the large intestine)
• cancer
• cancer affecting the lymphatic system
• melanoma
• immunological alterations that may affect the lungs, skin, and lymph nodes (the most common presentation is sarcoidosis)
• vasculitis (inflammation of blood vessels)
• tremor (feeling shaky)
• neuropathy (nerve disorder)
• stroke
• loss of hearing, ringing in the ears
• sensation of irregular pulse like skipping
• heart problems that may cause difficulty breathing or swelling of the ankles
• heart attack
• sac in the wall of a major artery, inflammation and coagulation in a vein, blockage of a blood vessel
• lung diseases that may cause difficulty breathing (including inflammation)
• pulmonary embolism (blockage of a pulmonary artery)
• 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)
• inflammation of the gallbladder, gallstones
• fat in the liver
• nocturnal sweating
• scars
• abnormal muscle crisis
• systemic lupus erythematosus (including skin inflammation, heart, lungs, joints, and other organ inflammation)
• sleep interruptions
• impotence
• inflammations

Rare(may affect up to 1 in 1000 people)

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

Frequency not known(cannot be estimated from available data)

• hepatosplenic T-cell lymphoma (rare blood cancer often fatal)
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually manifests as purple skin lesions
• hepatic failure
• worsening of a disease called dermatomyositis (seen as skin rash accompanied by muscle weakness)
• weight gain (for most patients, weight gain was reduced)

Some side effects observed in clinical trials do not have symptoms and can only be identified through blood analysis. These include:

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

• low white blood cell count
• low red blood cell count
• high lipid levels in blood
• high liver enzyme levels

Common(may affect up to 1 in 10 people)

• high white blood cell count
• low platelet count
• high uric acid levels in blood
• abnormal sodium levels in blood
• low calcium levels in blood
• low phosphate levels in blood
• high blood sugar
• high lactate dehydrogenase levels in blood
• presence of autoantibodies in blood
• low potassium levels in blood

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 counts in blood for white cells, red cells, and platelets

Reporting of side effects

If your child experiences any type of side effect, consult with your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label/blister/carton after “CAD”.

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

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

Alternative storage:

When necessary (for example when traveling), you may store an individual pre-filled syringe of Humira at room temperature (up to 25°C) for a maximum period of 14 days - ensure it is protected from light. Once removed from the refrigerator to store the syringe at room temperature,you must use it within the next 14 days or discard it, even if you return it to the refrigerator.

You must note the date when you removed the syringe from the refrigerator, and the date after which you must discard the syringe.

Medicines should not be disposed of through drains or in the trash. Ask your doctor or pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of Humira

The active ingredient is adalimumab.

The other components are mannitol, polisorbate 80, and water for injectable preparations.

Appearance of the product and contents of the package

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

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

The pre-filled syringe of Humira is available in a package that contains 2 pre-filled syringes with 2 alcohol-soaked wipes.

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

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Manufacturer

AbbVie Biotechnology GmbH

Knollstrasse

67061 Ludwigshafen

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Last review date of this leafletof this leaflet

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

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

7.How to inject Humira

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

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

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

• After being correctly instructed, your child or another person, such as a family member or friend, can give the injection.

• Use only each pre-filled syringe for one injection.

Humira Pre-filled Syringe

PlungerShutterCap

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

• the liquid is cloudy, colored, or has scales or particles in it
• the expiration date (EXP) has passed
• the liquid has been frozen or exposed to direct sunlight
• the pre-filled syringe has fallen or been crushed

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