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This website is intended for patients in New Zealand who have been prescribed AMGEVITA^® (adalimumab)

IMPORTANT INFORMATION ABOUT AMGEVITA: AMGEVITA^® is a prescription medicine containing adalimumab. AMGEVITA is available as single use pre-filled syringe(s) (containing 20 mg or 40 mg adalimumab) or single-use pre-filled pens (containing 40 mg adalimumab). AMGEVITA is a biosimilar medicine comparable to Humira^®. What AMGEVITA is used for. AMGEVITA is used to reduce inflammation in patients with some inflammatory diseases, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, Crohn's disease, ulcerative colitis, hidradenitis suppurativa, and uveitis. AMGEVITA has risks and benefits. Do not use AMGEVITA if you have: an allergy to any medicines containing adalimumab or any of the other ingredients in AMGEVITA; a severe infection; tuberculosis (known as TB); moderate-severe heart failure; or if using a medicine containing anakinra or abatacept (Orencia^®). Before you use AMGEVITA tell your doctor if you have: a current infection or a history of infections that keep coming back (including TB, hepatitis B, fungal or any other infection); any conditions that increase the risk of infections; had close contact with someone with TB, or Hepatitis B virus (HBV) or are a carrier of HBV; conditions that affect protective nerve layers, such as multiple sclerosis; blood disorders; low resistance to infections or diseases; any serious heart conditions or cancers; disorders that occur when the immune system attacks and destroys healthy cells, tissues, or organs by mistake; lung diseases that make breathing difficult; inflammation of the middle layer of the eye (uveitis); kidney or liver problems; psoriasis (a type of skin disease) 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 AMGEVITA. 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. Tell your doctor immediately or go to your nearest hospital if you develop symptoms: of an allergic reaction, such as chest tightness, shortness of breath or difficulty breathing, swelling of the face, lips or tongue, or a rash; heart problems, such as shortness of breath with exertion or lying down, swollen feet; or signs of blood disorders, such as a persistent fever, bruising, bleeding easily, paleness. Tell your doctor straight away if: symptoms of TB or any other infection appear during treatment (such as fever, persistent cough, weight loss, listlessness or lack of energy, skin sores, problems with your teeth and gums, burning when you pass urine, etc); you develop cancer, skin lesions (new skin spots or sores), or if existing lesions change appearance; nervous system disorders (such as numbness, or tingling, arm or leg weakness, double vision). Tell your doctor straight away if you become pregnant while using AMGEVITA. If you use AMGEVITA 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 AMGEVITA use during your pregnancy before the baby receives any vaccine. Tell your doctor and other health care professionals: 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 AMGEVITA should not receive live vaccines. Tell all doctors, dentists, and pharmacists who are treating you that you are using AMGEVITA. Common Side Effects: Tell your doctor if you experience any side effects that make you feel unwell. The most common side effects of this medicine are injection site reactions (e.g. pain, swelling, redness); respiratory tract infections; ear or eye pain, inflammation of the eye or eye lid; mouth ulcers, pain or bleeding from the gums; burning or pain when passing urine or blood in the urine; skin bumps or sores that don’t heal; headache or migraine, dizziness; muscle weakness or numbness; tummy pain, nausea, vomiting, reflux or heartburn; chest pain; rash, itching; finger or toe nail problems; hair loss; tiredness; muscle, joint or bone pain; bleeding or bruising more easily; depression or anxiety; increased heart rate; and infections caused by viruses, bacteria or fungi. Your doctor might also tell you about abnormal laboratory test results, such as reduced blood cell counts for example. Ask your doctor if AMGEVITA is right for you. Use strictly as directed. Please read the safety information in the AMGEVITA Consumer Medicines Information (CMI), available at www.medsafe.govt.nz/Consumers/cmi/a/amgevita.pdf or telephone 0800 443 885 (free call). If you have any questions about using AMGEVITA, or if symptoms continue, or you have side effects, speak to your healthcare professional.

AMGEVITA is fully funded for most of the above conditions (under Special Authority) except for enthesitis-related arthritis and nonradiographic axial spondyloarthritis. Normal pharmacy prescription and doctor’s charges will apply. Amgen (New Zealand) Limited, Auckland, New Zealand. Telephone: 0800 443 885. E-mail medinfo.JAPAC@amgen.com.

For more information on AMGEVITA or to report an adverse event or product complaint involving AMGEVITA, please contact Amgen Medical Information on 0800 443 885 or email: medinfo.JAPAC@amgen.com

References: 1. AMGEVITA^® SureClick Instructions for use 11 November 2021. Available at: https://www.amgevita.co.nz/-/media/Themes/Amgen/Amgevita-nz/Amgevita-nz/pdf/amgevita_nz_%20pf_pen_ifu Accessed July 2024. 2. AMGEVITA^® pre-filled syringe Instructions for use 11 November 2021. Available at: https://www.amgevita.co.nz/-/media/Themes/Amgen/Amgevita-nz/Amgevita-nz/pdf/amgevita_nz_syringe_ifu Accessed July 2024. 3. AMGEVITA^® Consumer Medicine Information. 4. AMGEVITA^® Approved Data Sheet. 5. Adalimumab Changes: What patients need to know. Available at: https://pharmac.govt.nz/medicine-funding-and-supply/medicine-notices/adalimumab/adalimumab-changes-what-patients-need-to-know/ Accessed September 2023.

© 2024 Amgen. All rights reserved.
Amgen (New Zealand) Limited, Level 22, PwC Tower,15 Customs Street West, Auckland 1010.
Telephone: 0800 443 885 | Email: medinfo.JAPAC@amgen.com
NZL-501-1223-80003. TAPS MR9895. Date of preparation: February 2024. AMG10379.

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