HUMIRA is a prescription medicine containing adalimumab. HUMIRA is available as a single use pre-filled syringe (containing 20mg or 40mg adalimumab) or single-use pre-filled pen (containing 40mg adalimumab). It is used in the treatment of patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, chronic plaque psoriasis, ulcerative colitis, Crohn’s disease, non-infectious uveitis, and hidradenitis suppurativa. HUMIRA is only used in patients of a specific age group, in diseases of certain severity (e.g. moderate to severe), and/or after some other treatments have been tried (e.g. conventional therapy).

HUMIRA has risks and benefits.

Do not use Humira if you have:

An allergy to any medicines containing adalimumab or any of the other ingredients in HUMIRA; a severe infection; tuberculosis (TB); moderate to severe heart failure; or are using a medicine containing anakinra (Kineret®) or abatacept (Orencia®).

Before you use HUMIRA tell your doctor if you have:

A current infection or a history of recurring infections (including TB, hepatitis B, fungal or any other infection); any conditions that increase the risk of infections; had close contact with someone with TB; a nervous system disease (such as multiple sclerosis); blood disorders; low resistance to disease; heart conditions; cancer; autoimmune disease; lung disease; uveitis (an eye problem); kidney or liver problems; psoriasis and have undergone phototherapy; or if you have any allergies.

Your risk of getting serious infections or certain kinds of cancer may increase if you take HUMIRA. In rare cases these infections may be life-threatening.

Tell your doctor if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.

Tell your doctor right away:

If symptoms of TB or any other infection appear during treatment (such as fever, cough, feeling tired, wounds etc); if you develop cancer, skin lesions, or if existing lesions change appearance; if you develop symptoms of an allergy (such as chest tightness, swelling, rash, shortness of breath), heart problems (shortness of breath, swollen feet), blood disorders (bruising, bleeding, paleness), nervous system disorders such as multiple sclerosis (numbness, tingling, muscle weakness) or if you become pregnant while using HUMIRA. If you use HUMIRA during pregnancy, your baby may have a higher risk of getting an infection. It is important that you tell your baby's doctors and other healthcare professionals about your HUMIRA use during your pregnancy before the baby receives any vaccine.

Tell your doctor:

If you are taking any other medicines, including any that you get without a prescription; if you are going to have surgery, or if you are scheduled for any vaccines.

Patients taking HUMIRA should not receive live vaccines.

Tell all doctors, dentists, and pharmacists who are treating you that you are using HUMIRA.

Side Effects:

Tell your doctor if you experience any side effects that make you feel unwell.

The most common side effects of HUMIRA are injection site reactions (e.g. pain, swelling, redness etc), respiratory tract infections, headache, dizziness, tiredness, mouth ulcers, tummy pain, nausea, vomiting, diarrhoea, rash, itching, muscle pain and infections caused by viruses, bacteria or fungi, as well as abnormal laboratory tests such as reduced blood cell count, increased liver test results, increased blood lipid test results, etc.

If you have any questions about using Humira, including the risks and benefits, how much to use, how and when to use it, or the storage conditions, ask your healthcare professional and refer to the Consumer Medicine Information (CMI) available here HUMIRA Pen CMI or HUMIRA Syringe CMI or freephone 0800 900 030. Ask your doctor if HUMIRA is right for you. Use strictly as directed. If symptoms continue, or you have side effects, see your doctor, pharmacist or healthcare professional.

AbbVie Limited, 6th floor, 156-158 Victoria Street, Wellington, 6011, New Zealand 0800 900 030.

NZ-HUM-190052 TAPS PP3271 Prepared April 2019