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PHARMAC Pharmaceutical Schedule: Effective 01 March 2022, please refer to the adalimumab Special Authority for AMGEVITA^® (adalimumab) indications that are fully subsidised. AMGEVITA^® is not funded for enthesitis-related arthritis or non-radiographic axial spondyloarthritis.

Important note: Consult full AMGEVITA^® data sheet at https://www.medsafe.govt.nz/Profs/Datasheet/a/amgevitainj.pdf before prescribing.

AMGEVITA^® (adalimumab) is a prescription medicine containing 20 mg/0.4 mL & 40 mg/0.8 mL Solution for injection. Indications: Ankylosing Spondylitis; Crohn's Disease; Enthesitis-Related Arthritis; Hidradenitis Suppurativa; Non-radiographic Axial Spondyloarthritis; Polyarticular Juvenile Idiopathic Arthritis; Psoriasis; Psoriatic Arthritis; Rheumatoid Arthritis; Ulcerative colitis; Uveitis. Presentations: adalimumab 20 mg/0.4mL pre-filled syringe; adalimumab 40 mg/0.8 mL pre-filled syringes/pen. Contraindications: hypersensitivity to adalimumab or excipients; severe infections; active tuberculosis (TB); moderate to severe heart failure (NYHA class III/IV); concurrent anakinra administration. Warnings and precautions: Serious or opportunistic infections; congestive heart failure (CHF); hepatitis B; TB; neurologic events; hypersensitivity reactions; haematologic events; immunosuppression; live vaccines; malignancies; autoimmune processes; concurrent administration of biologic DMARDS or TNF-antagonists; psoriasis - use with systemic agents/phototherapy; surgery. Removable cap of pre-filled pen contains natural rubber (a derivative of latex). Pregnancy. Lactation. Adverse reactions: Very common: injection site reactions, respiratory tract infections; leucopenia; anaemia; headache; abdominal pain, nausea; vomiting; musculoskeletal pain; elevated lipids; elevated liver enzymes; and rash. Common: sepsis; other infections; benign neoplasm; skin cancer excluding melanoma; thrombocytopenia; leucocytosis; hypersensitivity; allergies; hypokalaemia; uric acid increased; blood sodium abnormal; hypocalcaemia; hyperglycaemia; hypophosphatemia; dehydration; mood alterations; anxiety; insomnia; paraesthesias; migraine; nerve root compression; visual impairment; conjunctivitis; blepharitis; eye swelling; vertigo; tachycardia; hypertension; flushing; haematoma; cough; asthma; dyspnoea; Gastrointestinal haemorrhage; dyspepsia; gastroesophageal reflux disease; sicca syndrome; cholecystitis & cholelithiasis; bilirubin increased; hepatic steatosis; pruritus; urticaria; bruising; dermatitis; onychoclasis; hyperhidrosis; muscle spasms, blood creatine phosphokinase increased; haematuria; renal impairment; chest pain; oedema; coagulation & bleeding disorders; activated partial thromboplastin time (APTT) prolonged; positive autoantibody test; blood lactate dehydrogenase (LDH) increased; and impaired healing. Serious (rare): fatal infections, including TB or invasive opportunistic infections. Dosage: See full data sheet. Method of administration: subcutaneous injection. Packs: 20 mg packs of 1; 40 mg packs of 2. AMGEVITA^® is a registered trademark of Amgen New Zealand Limited, Auckland. Phone 0800 443 885.

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

References: 1. Decision to widen access to adalimumab and award Principal Supply, 17 November 2021. Available at: https://pharmac.govt.nz/news-and-resources/consultations-and-decisions/2021-11-17-decision-to-widen-access-to-adalimumab-and-award-principal-supply/ Accessed November 2021. 2. Amgen Biosimilars. Expertise - Quality Assurance. Available at: https://www.amgenbiosimilars.com/expertise/quality-assurance. Accessed December 2021. 3. Amgen. Data on file, 2019. 4. AMGEVITA^® Approved Data Sheet. 5. Cohen SB et al. Ann Rheum Dis. 2017;76:1679-1687. 6. Papp K et al. J Am Acad Dermatol. 2017;76:1093-1102. 7. Cohen SB et al. Arth Res Ther. 2019;21:84. 8. Australian Register of Therapeutic Goods. Available at: www.tga.gov.au/australian-register-therapeutic-goods. Accessed 4 March 2021. 9. AMGEVITA^® access criteria. Available at: https://pharmac.govt.nz/assets/2021-11-Amgevita-Special-Authority.pdf. Accessed 23 Dec 2021 10. PHARMAC Adalimumab (Amgevita & Humira): Information for health care professionals. https://pharmac.govt.nz/medicine-funding-and-supply/medicine-notices/adalimumab/adalimumab-amgevita-information-for-health-care-professionals/ Accessed September 2023.

Humira^® is a registered trademark of AbbVie Biotechnology Ltd.

© 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-501-1223-80004. TAPS MR9895. Date of preparation: February 2024. AMG13079.

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