bDMARDs Quick Reference Guide

Ustekinumab (subcut)

Ustekinumab (subcut)

Active ingredient

Ustekinumab

Mechanism of action

Interleukin (IL) -12 and -23 inhibitor

Molecule type

IgG monoclonal antibody (recombinant human)

PBS listed indications

RheumatologySevere psoriatic arthritis
DermatologySevere chronic plaque psoriasis
GastroenterologySevere Crohn disease

Reference product (brand)

Stelara SC

Biosimilar brands

None

Administration information

Mode of administration

Subcutaneous injection

Administration devices and strengths

Vial for subcutaneous injection 45mg/0.5 mL

 

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

Frequency of administration

Varies (see dosing information).

Storage

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

Keep vials in the outer carton until time of use to protect from light.

Do not shake.

Standard dosing

Psoriatic arthritis and plaque psoriasis: 45mg at weeks 0 and 4, then every 12 weeks.

Crohn disease (maintenance dosing): 90mg (2 x 45mg injections) at week 8, then once every 8 weeks.

The two 45mg injections should be administered at different sites.

 

Treatment with csDMARDs (e.g., methotrexate) may be continued during treatment with ustekinumab.

Dose variations

Crohn disease: patients who have adequate response to dosing every 8 weeks may have the dose interval increased to every 12 weeks.

Psoriatic arthritis and plaque psoriasis: patients >100kg, consider using 90mg for each dose (clear benefit shown for plaque psoriasis, less clear evidence for psoriatic arthritis).

Plaque psoriasis: If response is inadequate, consider dosing every 8 weeks.

This dosing may be outside PBS funding. Specialist prescribers may arrange supply through alternate pathways. 

Special notes

Evidence for therapeutic drug level monitoring of ustekinumab to guide dosing in Crohn disease is currently lacking. Maintenance levels of >1.2microgram/mL seem to sustain clinical response.

 

Immunosuppression may increase risk and severity of infection. Ustekinumab should be used with caution in serious or untreated infection, e.g. sepsis, hepatitis B, active TB (before completing treatment).
May reactivate inactive hepatitis B and latent TB (begin TB treatment before starting ustekinumab).

Patients with suspected latent or active TB should be treated in consultation with an Infectious Diseases physician.

 

Live vaccines should not be given concurrently with ustekinumab or for 15 weeks after cessation of therapy.

References

Pharmaceutical benefits Scheme (PBS) listing. Available from   https://www.pbs.gov.au/medicine/item/10767Q-10774C-11164N-11178H-11182M-9304Q-9305R [accessed 6/10/21]

Product information. Available from   https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-PI-02581-1 [accessed 6/10/21]

Australian Medicines Handbook 2020 (online). Adelaide: Australian Medicines Handbook Pty Ltd; 2020 July. Available from: https://amhonline.amh.net.au/  [accessed 13/5/21]

Gutiérrez A, Rodríguez-Lago I. How to Optimize Treatment With Ustekinumab in Inflammatory Bowel Disease: Lessons Learned From Clinical Trials and Real-World Data. Front Med (Lausanne). 2021;8:640813.