PracticeUpdate: Dermatology - Vol 1 - No.1 - 2017

BRENZYS etanercept ®

The first available etanercept biosimilar in Australia 1

QUALITY * SUPPORT † VALUE ‡

PBS Information: This product is not listed on the PBS. PLEASE REVIEW THE PRODUCT INFORMATION BEFORE PRESCRIBING – AVAILABLE FROM WWW.MSDINFO.COM.AU/BRENZYSPI. BRENZYS [etanercept (rch)] Indications: rheumatoid arthritis; psoriatic arthritis; plaque psoriasis; ankylosing spondylitis; non-radiographic axial spondyloarthritis in adults ( ≥ 18 years); not indicated for use in children under 18 years. Contraindications: Hypersensitivity to any component of this product; patients with, or at risk of sepsis; patients with serious active infection including chronic or localised infections; concurrent treatment with Interleukin-1 antagonists. Precautions: Infections: tuberculosis, reactivation of hepatitis B, worsening of hepatitis C; alcoholic hepatitis; hypoglycaemia in patients treated for diabetes; concurrent administration of TNF inhibitors and anakinra; concurrent administration with abatacept; haematological reactions; allergic reactions; congestive heart failure; neurological disorders; concurrent use in psoriasis; lymphomas, leukaemia, other malignancies, melanoma and non-melanoma skin cancer; immunosuppression; vaccinations; autoantibody formation; fertility effects, use in pregnancy, lactation; not indicated in children under 18 years;use in elderly. Pregnancy Category: D. Interactions: methotrexate; abatacept; anakinra; cyclophosphamide; live vaccines; sulfasalazine; digoxin; warfarin. Adverse Effects: injection site reactions; infections; malignancies and lymphoproliferative disorders; autoantibody formation; psoriasis; headache; rhinitis; dizziness; pharyngitis; cough; asthenia; abdominal pain; rash, respiratory disorder; sinusitis; allergic reactions; fever see full PI. Dosage: rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis: 50mg per week SC. Plaque psoriasis: 50mg per week once weekly or initially 50mg twice weekly for 12 weeks then 50mg per week thereafter. See full PI. Based on PI approved 14 October 2016 References: 1. Australian Register of therapeutic Goods. ttps://www.tga.gov.au/australian-register-therapeutic-goods. Accessed 5 January 2017. 2. Emery P et al. Ann Rheum Dis 2015;0:1–7. 3. Data on file. 4. Department of Health. Pharmaceutical Benefits Scheme to be reformed (Available at: http://www.health.gov.au/internet/ministers/ publishing.nsf/Content/health-mediarel-yr2015-ley063.htm, accessed: January 2017). *BRENZYS demonstrated equivalent efficacy and comparable safety and immunogenicity to originator etanercept 2 † MSD will provide comprehensive support for patients prescribed BRENZYS as well as support and education for health care professionals 3 ‡ Biosimilars have the potential to deliver greater affordability to the Australian healthcare system 4

Copyright © 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA. All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited. Level 1, Building A, 26 Talavera Road Macquarie Park, NSW 2113 Australia. BIOS-1209351-0000. February 2017. MSDBIO0011RC