bDMARDs Quick Reference Guide

Vedolizumab (subcut)

Vedolizumab (subcut)

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 SC

Biosimilar brands

None

Administration information

Mode of administration

Subcutaneous injection

Administration devices and strengths

Pre-filled pen 108mg/0.68mL

Pre-filled syringe 108mg/0.68mL

Note: while both subcutaneous products are TGA registered, only the pre-filled pen is PBS listed

 

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

Frequency of administration

Every 2 weeks (maintenance)

Storage

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

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

After removing the pre-filled pen or syringe from the refrigerator, wait 30 minutes to allow them to come to room temperature before administration.

Standard dosing

Subcutaneous injections are for maintenance therapy only.

Following at least 2 IV infusions, the first subcutaneous dose should be administered in place of the next scheduled IV dose - then 108mg every 2 weeks thereafter.

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

Special notes

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 inhibitors).
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 6/10/21]

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