bDMARDs Quick Reference Guide
| Rheumatology | Ankylosing spondylitis Severe active juvenile idiopathic arthritis* Severe psoriatic arthritis Severe active rheumatoid arthritis |
| Dermatology | Severe chronic plaque psoriasis* |
*Paediatric dosing information is outside the scope of this guide. Please refer to paediatric specific references if required.
Brenzys
| Device and strength | Indication | PBS item code(s) | Brands funded |
| Pre-filled syringe 50mg/mL | Ankylosing spondylitis | 11196G 9085E 9086F | Enbrel Brenzys |
| 11217J Streamlined authority (9481) | Brenzys | ||
| Severe psoriatic arthritis | 11208X 9087G 9088H | Enbrel Brenzys | |
| 11216H Streamlined authority (9156) | Brenzys | ||
| Severe rheumatoid arthritis | 11219L 9089J 9090K | Enbrel Brenzys | |
| 11211C Streamlined authority (7276) | Brenzys | ||
| Severe chronic plaque psoriasis | 11224R 9091L 9431J | Enbrel Brenzys | |
| 11225T Streamlined authority (8887 and 8955) | Brenzys | ||
| Auto-injector 50mg/mL | Ankylosing spondylitis | 11201M 9455P 9456Q | Enbrel Brenzys |
| 11215G Streamlined authority (9481) | Brenzys | ||
| Severe psoriatic arthritis | 11198J 9457R 9458T | Enbrel Brenzys | |
| 11202N Streamlined authority (9156) | Brenzys | ||
| Severe active rheumatoid arthritis | 11220M 9459W 9460X | Enbrel Brenzys | |
| 11218K Streamlined authority (7276) | Brenzys | ||
| Severe chronic plaque psoriasis | 11222P 9461Y 9462B | Enbrel Brenzys | |
| 11221N Streamlined authority (8887 and 8955) | Brenzys |
Powder and inert diluent vials for subcutaneous injection
Enbrel - 25mg
Pre-filled syringe
Enbrel - 50mg/mL
Brenzys - 50mg/mL
Auto-injector
Enbrel - 50mg/mL
Brenzys - 50mg/mL
Instructions for patient self-administration for both Enbrel and Brenzys are included with the product.
Store at 2 – 8oC (refrigerate do not freeze).
Keep pre-filled syringes and auto-injectors in the outer carton until time of use to protect from light.
Powder for injection (Enbrel): Once reconstituted, solution must be refrigerated and used within 6 hours.
Prior to reconstitution, the powder may be stored at temperatures of up to 25oC for a single period of up to 4 weeks. Should be discarded if exposed to temperatures >25oC or if not used within 4 weeks of initial removal from refrigeration. Do not return to the fridge.
Pre-filled syringes and auto-injectors (Enbrel and Brenzys): May be stored at temperatures of up to 25oC for a single period of up to 4 weeks. Should be discarded if exposed to temperatures >25oC or if not used within 4 weeks of initial removal from refrigeration. Do not return to the fridge.
After allowing the etanercept syringe or auto-injector to reach room temperature (approximately 15-30 minutes), immediate use is recommended.
All indications: 50mg once a week or 25mg twice a week (3-4 days apart)
Treatment with csDMARDs (e.g., methotrexate) may continue during treatment with etanercept.
Patients with rheumatoid arthritis who are in remission or have low disease activity may have their dose of etanercept down-titrated by their rheumatologist.
Plaque psoriasis:
Higher responses may be achieved from initial treatment for up to 12 weeks with a dose of 50mg twice a week after which the dose should be reduced to 50mg once a week.
This dosing may be outside PBS funding. Specialist prescribers may arrange supply through alternate pathways.
Etanercept is not recommended for patients with serious or untreated infection, e.g. sepsis, abscess, hepatitis B, active TB (before completing TB treatment).
May reactivate inactive hepatitis B and latent TB (begin TB treatment before starting a TNF-alpha inhibitor). The risk of latent TB reactivation is less with etanercept than with other TNF-alpha inhibitors.
Patients with suspected latent or active TB should be treated in consultation with an Infectious Diseases physician.
Treatment with another cytokine modulator (e.g. TNF-alpha inhibitor, abatacept, anakinra, rituximab, tocilizumab) is not recommended due to increased risk of infection.
TNF-alpha inhibitors like etanercept are contraindicated with anakinra.
Etanercept is contraindicated in moderate or severe heart failure (NYHA class III–IV) and left ventricular ejection fraction <50%; use cautiously in mild disease as TNF-alpha inhibitors may worsen heart failure.
Rare cases of serious blood dyscrasias (some fatal) have been reported in patients taking etanercept. Monitor full blood count regularly.
A drug-induced lupus is rarely seen following administration of any TNF-alpha inhibitor. Patients presenting with a new rash or joint pain should be referred to their prescriber. This does not represent a class effect, and patients may be successfully rechallenged with a different TNF-alpha inhibitor without recurrence of a drug-induced lupus.
Live vaccines should not be given concurrently with etanercept.
Pharmaceutical benefits Scheme (PBS) listing. Available from https://www.pbs.gov.au/pbs/search?term=etanercept&analyse=false&search-type=medicines [accessed 8/10/21]
Product information. Available from https://search.tga.gov.au/s/search.html?collection=tga-websites-web&query=etanercept [accessed 8/10/21]
Australian Medicines Handbook 2020 (online). Adelaide: Australian Medicines Handbook Pty Ltd; 2020 July. Available from: https://amhonline.amh.net.au/
NPS Medicinewise. Down-titration strategies. Available from https://www.nps.org.au/bdmards/rheumatology-conditions/titration-strategies [accessed 10/5/21]