Humira 40 mg/0,4 ml Solution

The active ingredient in HUMIRA, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target. The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Humira decreases the process of inflammation in these diseases.

WHAT IS HUMIRA USED FOR:

Adults

• Rheumatoid Arthritis is an inflammatory disease of the joints. HUMIRA is used to treat rheumatoid arthritis in adults.
• Psoriatic Arthritis is an inflammation of the joints associated with psoriasis. HUMIRA is used to treat psoriatic arthritis in adults.
• Plaque Psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. HUMIRA is used to treat plaque psoriasis in adults.
• HUMIRA is indicated for moderate to severe nail psoriasis in adult patients who are candidates for systemic therapy.
• Axial Spondyloarthritis including ankylosing spondylitis is the inflammatory diseases of the spine. HUMIRA is used to treat axial spondyloarthritis in adults.
• Ankylosing Spondylitis is the inflammatory diseases of the spine. HUMIRA is used to treat ankylosing spondylitis in adults.
• Crohn’s disease is an inflammatory disease of the digestive tract. HUMIRA is used to treat Crohn’s disease in adults.
• Ulcerative colitis is an inflammatory disease of the bowel. HUMIRA is used to treat ulcerative colitis in adults.
• Hidradenitis Suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas. HUMIRA is used to treat hidradenitis suppurativa in adults.
• Uveitis is an inflammatory disease affecting certain parts of the eye. HUMIRA is used to treat adults with non-infectious uveitis.

Paediatrics

• 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.
• Paediatric Crohn's Disease is an inflammatory disease of the digestive tract. HUMIRA is used to treat Crohn’s disease in children and adolescents from 6 years of age and older.
• Paediatric Plaque Psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. HUMIRA is used to treat plaque psoriasis in children and adolescents from 4 years of age.
• Paediatric Uveitis Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. Humira is used to treat children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.
• Paediatric Ulcerative colitis is an inflammatory disease of the bowel. HUMIRA is used to treat ulcerative colitis in paediatric patients 5 years of age or older.

Do not use HUMIRA:

• If you are allergic (hypersensitive) to adalimumab or any of the other ingredients of HUMIRA.
• If you have a severe infection, including active tuberculosis (see “Take special care with HUMIRA”). It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.
• If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Take special care with HUMIRA”).
• If you are to receive live vaccines, they should not be given while receiving HUMIRA. Please check with your doctor before you receive any vaccines.

Take special care with HUMIRA:

• If you experience allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash do not inject more HUMIRA and contact your doctor immediately.
• The needle cover of the syringe contains natural rubber (latex). This may cause severe allergic reactions in patients sensitive to latex. Patients who have a known sensitivity to latex should be advised to avoid touching the inner shield.
• If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting HUMIRA. If you are unsure, please contact your doctor.
• You might get infections more easily while you are receiving HUMIRA treatment including serious infections, tuberculosis, opportunistic infections and sepsis that may, in rare cases, be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.
• As cases of tuberculosis have been reported in patients treated with HUMIRA, your doctor will check you for signs and symptoms of tuberculosis before starting HUMIRA. This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example a chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Alert Card. It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
• Tuberculosis can develop during therapy even if you have received preventative treatment for tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
• Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
• Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV. HUMIRA can cause reactivation of HBV in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
• If you are about to undergo surgery or dental procedures please inform your doctor that you are taking HUMIRA.
• If you have multiple sclerosis, your doctor will decide if you should receive HUMIRA.
• Some vaccines should not be given while receiving HUMIRA. Please check with your doctor before you receive any vaccines.
• If you have mild heart failure and you are being treated with HUMIRA, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
• In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.
• There have been very rare cases of certain kinds of cancer in patients taking HUMIRA or other TNF blockers. People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system (lymphoma) or the cancer of the white blood cells (leukaemia). If you take HUMIRA your risk may increase. In addition very rare cases of non-melanoma skin cancer have been observed in patients taking HUMIRA.
• Cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
• Caution should be used when treating the elderly because there is a higher incidence of infections in the elderly population.

Using other medicines with HUMIRA:

HUMIRA can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You should not take HUMIRA with medicines containing the active substance anakinra or abatacept. If you have questions, please ask your doctor.

Using HUMIRA with food and drink

Since HUMIRA is given subcutaneously, food and drink should not affect HUMIRA.

Pregnancy and breast-feeding

You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last HUMIRA treatment. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine. HUMIRA should only be used during a pregnancy if needed. According to a pregnancy study, there was no higher risk of birth defects when the mother had received HUMIRA during pregnancy compared with mothers with the same disease who did not receive HUMIRA. HUMIRA can be used during breast-feeding. If you receive HUMIRA during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your HUMIRA use during your pregnancy before the baby receives any vaccine.

Driving and using machines

HUMIRA should not affect your ability to drive or use machinery.

Do not share HUMIRA, which is prescribed for you, with other people. Always take HUMIRA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. HUMIRA is injected under the skin (subcutaneous use).

Your doctor will determine and prescribe the appropriate dosage(s) according to your condition and other aspect of your treatment.

Adults

The usual dose for adults with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis is 40 mg of HUMIRA given every other week as a single dose. In rheumatoid arthritis and juvenile idiopathic arthritis, methotrexate is continued while using HUMIRA. If your doctor determines that methotrexate is inappropriate, HUMIRA can be given alone. If you have rheumatoid arthritis and you do not receive methotrexate with your HUMIRA therapy, your doctor may decide to give HUMIRA 40 mg every week or 80 mg every other week.

The recommended HUMIRA dose regimen for adult patients with Crohn’s disease is 160 mg at week 0 (given as 160 mg in one day or as 80 mg per day for two consecutive days), 80 mg at week 2, and followed 2 weeks later by a maintenance dose of 40 mg every other week via subcutaneous injection. Depending on your response, your doctor may decide to give HUMIRA 40 mg every week or 80 mg every other week.

The recommended HUMIRA dose regimen for adult patients with ulcerative colitis is 160 mg at Week 0 (given as 160 mg in one day or as 80 mg per day for two consecutive days) and 80 mg at Week 2, and thereafter 40 mg every other week. Depending on your response, your doctor may increase the dose to 40 mg every week or 80 mg every other week.

The usual dose for adults with psoriasis is an initial does of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. Depending on your response, your doctor may increase the dose to 40 mg every week or 80 mg every other week.

Adults with Hidradenitis Suppurativa

The usual dose regimen for hidradenitis suppurativa is an initial does of 160 mg (given as 160 mg in one day or as 80 mg per day for two consecutive days), followed by 80 mg two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week. It is recommended that you use an antiseptic wash daily on the affected areas.

Uveitis

The recommended dose of HUMIRA for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. HUMIRA can be used alone or in combination with corticosteroids.

Paediatrics

Polyarticular juvenile idiopathic 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

Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg 20 mg every other week

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 First dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every other week.

Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg First dose of 20 mg, followed by 20 mg one week later. Thereafter, the usual dose is 20 mg every other week.

Paediatric 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 First dose of 160 mg, followed by 80 mg two weeks later. Thereafter, the usual dose is 40 mg every other week. Your child’s doctor may increase the dose frequency to 40 mg every week or 80 mg every other week.

Children and adolescents from 6 to 17 years of age weighing less than 40 kg First dose of 80 mg, followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every other week. Your child’s doctor may increase the dose frequency to 20 mg every week.

Paediatric Uveitis

Age or body weight How much and how often to take? Notes

Children and adolescents from 2 years of age weighing less than 30 kg 20 mg every other week Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week. HUMIRA is recommended for use in combination with methotrexate.

Children and adolescents from 2 years of age weighing at least 30 kg 40 mg every other week Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week. HUMIRA is recommended for use in combination with methotrexate.

There is no relevant use of HUMIRA in children aged less than 2 years in this indication.

Paediatric Ulcerative Colitis

The recommended dose of HUMIRA for patients from 5 to 17 years of age with ulcerative colitis is based on body weight. HUMIRA is administered via subcutaneous injection. HUMIRA may be available in different strengths and/or presentations.

Humira Dose for Paediatric Ulcerative Colitis

Patient Weight Induction Dose Maintenance Dose Starting at Week 4*

< 40 kg • 80 mg at Week 0 and • 40 mg at Week 2 • 40 mg every other week or • 20 mg every week

≥ 40 kg • 160 mg at Week 0 and • 80 mg at Week 2 • 80 mg every other week or • 40 mg every week

* Paediatric patients who turn 18 years of age while on HUMIRA should continue their prescribed maintenance dose.

You should continue to inject HUMIRA for as long as instructed by your doctor.

Instructions for preparing and giving an injection of HUMIRA:

The following instructions explain how to inject HUMIRA. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor or his/her assistant on the technique of self-injection. Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection. After proper training, the injection can be self-administered or given by another person, for example a family member or friend. Only use each pre-filled pen for one injection.

HUMIRA can have side effects. If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• Severe rash, hives or other signs of allergic reaction
• Swollen face, eyelids, lips, tongue, throat, hands, feet
• Trouble breathing, swallowing
• Shortness of breath with exertion or upon lying down or swelling of the feet

These are very serious side effect. If you have them, you may have had a serious allergic to HUMIRA. You may need urgent medical attention or hospitalisation.

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

• Signs of infection such as fever, malaise, wounds, dental problems, burning on urination
• Feeling weak or tired
• Coughing
• Tinglings
• Numbness
• Double vision
• Arm or leg weakness
• A bump or open sore that doesn’t heal

The symptoms described above can be signs of the below listed side effects, which have been observed with HUMIRA:

Frequent:

• injection site reactions (including pain, swelling, redness or itching)
• respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, inflammation of the mucous membrane of any sinus (sinusitis), inflammation of the mucous membrane and underlying parts of the pharynx (pharyngitis, nasopharyngitis) and pneumonia herpes viral
• anaemia, low white blood cell counts
• headache
• abdominal pain, nausea and vomiting
• urinary tract infection, cold blisters, shingles, serious infections (such as sepsis [blood poisoning]), fungal infections, ear infection, tooth infection, skin infection, wound infection
• dizziness, headache;
• cough, sore throat, nausea, diarrhoea, abdominal pain, elevated liver enzymes;
• rash, itching, hair loss;
• fatigue
• allergic reactions
• mood alteration (including depression), anxiety, insomnia
• asthma, shortness of breath, cough
• vertigo
• dehydration
• joint infection
• visual impairment, conjunctivitis (inflammation of the membrane that lines the eyelid), blepharitis (inflammation of the eye lids), eye swelling

Less Frequent:

• opportunistic infections and tuberculosis, eye infections, bacterial infections
• skin wart;
• nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances;
• double vision
• confusion;
• sensation of heart beating rapidly, high blood pressure;
• abdominal symptoms (such as vomiting, indigestion, constipation), mouth ulcers, mouth disorder, toothache;
• skin disorders (such as eczema or infections), skin, ulcer, itchy rash, slow wound healing;
• bursitis, muscle weakness;
• urinary disturbances (such as blood in urine, increased urinary frequency especially at night);
• inflammation
• abnormal laboratory tests
• erectile dysfunction
• deafness, tinnitus (buzzing in the ear)
• night sweat
• neuropathy (an abnormal and usually degenerative state of the nervous system or nerves)
• systemic lupus erythematosus (an inflammatory connective tissue disease of unknown cause that is characterized especially by fever, skin rash, and arthritis)

Other side effects that have been observed in patients taking HUMIRA: tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered); lung disease, baldness, a skin disease characterized by papular or vesicular lesions and reddening or discoloration of the skin often in concentric zones about the lesions, infection of a diverticulum of the colon that is marked by abdominal pain or tenderness often accompanied by fever, chills, and cramping, obstruction of a blood vessel by blood clot that is marked by laboured breathing, sharp chest pain that is worse with cough or deep breaths due to accumulation of fluid between the layers of tissue that line the lungs and chest cavity, scarring of the lung tissue marked by difficulty in breathing, fainting, rapid heart rate, cyanosis, shock, and sometimes death, sarcoidosis (an inflammatory disease that starts as tiny, grain-like lumps called granulomas, which most often appear in your lungs or lymph nodes).

The following side effects with unknown frequency have been observed in patients taking HUMIRA:

• merkel cell carcinoma (a type of skin cancer).
• Pyrexia
• lichenoid skin reaction (itchy reddish-purple skin rash)

If any side effects get serious, if you have any unusual effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advise.

Reporting of side effects

If you get side effects, talk to your . You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of HUMIRA. You can also report side effects to AbbVie (Pty) Ltd via this e-mail address: [email protected]

Keep out of the reach and sight of children. Do not use the HUMIRA pre-filled pen after the expiry date stated on the label/blister/carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 °C – 8 °C). A HUMIRA pre-filled syringe or Pen may be stored at temperatures up to a maximum of 25°C for a single period of up to 14 days. The syringe or Pen must be protected from light, and discarded if not used within the 14-day period. Keep the pre-filled pen in the outer carton. Do not freeze.