bDMARDs Quick Reference Guide

Etanercept

Etanercept

HomeMonographsEtanercept

Active ingredient

Etanercept

Mechanism of action

Tumour necrosis factor (TNF) – alpha inhibitor

Molecule type

Fully recombinant human molecule

PBS listed indications

RheumatologyAnkylosing spondylitis

Severe active juvenile idiopathic arthritis*

Severe psoriatic arthritis

Severe active rheumatoid arthritis

DermatologySevere chronic plaque psoriasis*

*Paediatric dosing information is outside the scope of this guide. Please refer to paediatric specific references if required.

Reference product (brand)

Enbrel

Biosimilar brands

Brenzys

Device and strengthIndicationPBS item code(s)Brands funded
Pre-filled syringe 50mg/mLAnkylosing spondylitis11196G

9085E

9086F

Enbrel

Brenzys

11217J

Streamlined authority (9481)

Brenzys
Severe psoriatic arthritis11208X

9087G

9088H

Enbrel

Brenzys

11216H

Streamlined authority (9156)

Brenzys
Severe rheumatoid arthritis11219L

9089J

9090K

Enbrel

Brenzys

11211C

Streamlined authority (7276)

Brenzys
Severe chronic plaque psoriasis11224R

9091L

9431J

Enbrel

Brenzys

11225T

Streamlined authority (8887 and 8955)

Brenzys
Auto-injector 50mg/mLAnkylosing spondylitis11201M

9455P

9456Q

Enbrel

Brenzys

11215G

Streamlined authority (9481)

Brenzys
Severe psoriatic arthritis11198J

9457R

9458T

Enbrel

Brenzys

11202N

Streamlined authority (9156)

Brenzys
Severe active rheumatoid arthritis11220M

9459W

9460X

Enbrel

Brenzys

11218K

Streamlined authority (7276)

Brenzys
Severe chronic plaque psoriasis11222P

9461Y

9462B

Enbrel

Brenzys

11221N

Streamlined authority (8887 and 8955)

Brenzys

Administration information

Mode of administration

Subcutaneous injection

Administration devices and strengths

Powder and inert diluent vials for subcutaneous injection

Enbryl - 25mg

Pre-filled syringe

Enbryl - 50mg/mL

Brenzys - 50mg/mL

Auto-injector

Enbryl - 50mg/mL

Brenzys - 50mg/mL

 

Instructions for patient self-administration for both Enbrel and Brenzys are included with the product.

Frequency of administration

Varies - see standard dosing information

Storage

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.

Standard dosing

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.

Dose variations

Patients with rheumatoid arthritis who are in remission or have low disease activity may have their dose of etanercept down-titrated by their rheumatologist.

  • Dose reduction - 50mg/week → 25mg/week
  • Dose interval increase
    • Stepwise increase in dose interval by 50% every 3 months (complete stop at fourth step)
    • 25mg/twice weekly → 25mg/week
    • 50mg/week → stepwise increase in dose interval every 3 months, to 50mg/10 days then 50mg/2 weeks (then stop)

 

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. 

Special notes

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.

References

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]