7 / 28
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
etanercept
®
*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
The first available
etanercept biosimilar
in Australia
1
QUALITY
*
SUPPORT
†
VALUE
‡
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