bDMARDs Quick Reference Guide

Vedolizumab (IV)

Vedolizumab (IV)

Active ingredient

Vedolizumab

Mechanism of action

Integrin receptor antagonist (α4β7)

Molecule type

IgG monoclonal antibody (humanised)

PBS listed indications

Moderate to severe ulcerative colitis

Severe Crohn disease

Reference product (brand)

Entyvio IV

Biosimilar brands

None

Administration information

Mode of administration

IV infusion

Administration devices and strengths

Vial for IV infusion 300mg (lyophilised powder)

Frequency of administration

Every 8 weeks (maintenance)

Storage

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

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

Storage condition
2oC – 8oC20o – 25oC
Reconstituted solution in vial8 hoursDo not hold
Diluted solution in 0.9% sodium chloride24 hours*12 hours*
Diluted solution in lactated Ringer’s8 hours*Do not hold

* This time assumes the reconstituted solution is immediately diluted in the 0.9% sodium chloride solution and held in the infusion bag only. Any time that the reconstituted solution was held in the vial should be subtracted from the time the solution may be held in the infusion bag.

∫ This period may include up to 12 hours at 20o – 25oC

Standard dosing

Crohn disease and ulcerative colitis: 300mg via IV infusion over 30 minutes, at weeks 0, 2 and 6, then every 8 weeks.

During treatment with vedolizumab, corticosteroids may be reduced and/or discontinued in accordance with standard of care.

Dose variations

Crohn disease - if there is no response after 3 doses, patients may benefit from a dose at week 10.

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

Crohn disease and ulcerative colitis - if there is loss of response, the dose may be increased to 300mg every 4 weeks. Review after 14 weeks and stop if no benefit is demonstrated.

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

Special notes

Monitor for possible anaphylactic and infusion reactions during and for 2 hours after the first 2 infusions (observe for 1 hour after further infusions or refer to your local hospital policy). Infusion reactions are usually mild and include headache, dizziness, pruritis, hypotension, hypertension, nausea, vomiting and pyrexia. If necessary stop or slow the rate of infusion and treat with an antihistamine, paracetamol and/or a corticosteroid.

 

At this time, the correlation between pharmacokinetics, immunogenicity, and response to vedolizumab is not understood well enough to define the role of therapeutic drug level monitoring in clinical practice, particularly for optimising therapy.

 

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

 

Live vaccines may be given concurrently with vedolizumab only if the benefits outweigh the risks.

References

Pharmaceutical benefits Scheme (PBS) listing. Available from    https://www.pbs.gov.au/medicine/item/10384M-10390W-10398G-10415E [accessed 13/5/21]

Product information. Available from    https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2014-PI-02140-1&d=202105131016933 [accessed 13/5/21]

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

Restellini S, Khanna R, Afif W. Therapeutic Drug Monitoring With Ustekinumab and Vedolizumab in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2018;24:2165-2172