bDMARDs Quick Reference Guide

Ustekinumab (IV)

Ustekinumab (IV)

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 IV

Biosimilar brands

None

Administration information

Mode of administration

Iv infusion

Administration devices and strengths

Vial for IV infusion 130mg/26mL

Frequency of administration

Initial dose only (Crohn disease)

Storage

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

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

Do not shake.

Diluted infusion solution may be stored for up to 8 hours below 25oC.

Standard dosing

Crohn disease: initial dose only given by IV infusion:

Body weight Dose
<55kg260mg
55-85kg390mg
>85kg520mg

 

Special notes

Hypersensitivity reactions including rash and urticaria can occur with IV infusion.

 

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/