bDMARDs Quick Reference Guide

Certolizumab pegol

Certolizumab pegol

Active ingredient

Certolizumab pegol

Mechanism of action

Tumour necrosis factor (TNF) – alpha inhibitor

Molecule type

Recombinant humanised antibody Fab’ fragment

PBS listed indications

Axial spondyloarthritis

  • Ankylosing spondylitis
  • Non-radiographic axial spondyloarthritis

Severe psoriatic arthritis

Severe active rheumatoid arthritis

Reference product (brand)

Cimzia

Biosimilar brands

None

Administration information

Mode of administration

Subcutaneous injection

Administration devices and strengths

Pre-filled syringe 200mg/mL

Pre-filled pen (Autoclicks®) 200mg/mL

Instructions for patient self-administration are outlined in the CMI.

Frequency of administration

Every 2 weeks

Storage

Refrigerate (2-8oC). Do not freeze. 

Keep pre-filled syringes and pens in the outer carton until time of use to protect from light.

If needed, certolizumab may be stored at room temperature (max 25oC) for a single period of up to 10 days with protection from light.

Once it has been stored at room temperature, it should not be placed back in the refrigerator and should be discarded if not used within 10 days.

Allow certolizumab to reach room temperature prior to injecting. This will take about 30 minutes for the prefilled syringe and 30-45 minutes for the pre-filled pen.

Standard dosing

All indications:

DoseFrequency
Loading400mgTwo x 200mg subcutaneous injections initially (week 0) and at weeks 2 and 4
Maintenance200mgEvery two weeks

Alternatively, 400mg/monthly has also been shown to be safe and effective

 

Treatment with csDMARDs (e.g., methotrexate) may continue during treatment with certolizumab.

Dose variations

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

  • Dose interval increase from 200mg/2 weeks → 200mg/4 weeks

Special notes

Certolizumab is not recommended for patients within 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).
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 certolizumab are contraindicated with anakinra.

 

Certolizumab 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 certolizumab. 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 certolizumab.

References

Pharmaceutical benefits Scheme (PBS) listing. Available from https://www.pbs./gov.au/pbs/search?term=certolizumab%20pegol&analyse=false&search-type=medicines [accessed 8/10/21]

Product information. Available from https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-02405-3 [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 3/5/21]