bDMARDs Quick Reference Guide

Guselkumab

Guselkumab

Active ingredient

Guselkumab

Mechanism of action

Interleukin (IL) -23 inhibitor

Molecule type

IgG monoclonal antibody (humanised)

PBS listed indications

Severe chronic plaque psoriasis

Severe psoriatic arthritis

Reference product (brand)

Tremfya

Biosimilar brands

None

Administration information

Mode of administration

Subcutaneous injection

Administration devices and strengths

Pre-filled syringe 100mg/mL

Pre-filled pen 100mg/mL

Instructions for patient self-administration are included with the product.

Frequency of administration

Every 8 weeks

Storage

Store at 2-8oC (refrigerate do not freeze).

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

Before use, remove the carton from the refrigerator and keep the pre-filled syringe inside the carton and allow to reach room temperature by waiting for 30 minutes.

Standard dosing

Plaque psoriasis and psoriatic arthritis: 100mg at week 0, week 4 and every 8 weeks thereafter.

 

Treatment with csDMARDs (e.g., methotrexate) can continue whilst the patient is on guselkumab.

Special notes

Guselkumab has the potential to reactivate latent TB (begin TB treatment before starting).
Patients with suspected latent or active TB should be treated in consultation with an Infectious Diseases physician.

Guselkumab may increase the risk of infection. Treatment should not be initiated in patients with clinically significant active infection until the infection resolves or is adequately treated.

 

Live vaccines should not be given concurrently with guselkumab or for at least 3 months after cessation of therapy.

References

Pharmaceutical benefits Scheme (PBS) listing. Available from https://www.pbs.gov.au/medicine/item/11614G [accessed 8/10/21]

Product information. Available from https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2018-PI-01506-1 [accessed 8/10/21]

Australian Medicines Handbook 2020 (online). Adelaide: Australian Medicines Handbook Pty Ltd; 2020 July. Available from: https://amhonline.amh.net.au/