vedolizumab: clinical use

Prescribing considerations

• Initiation and supervision should be by clinicians experienced in ulcerative colitis, Crohn’s disease or, for intravenous treatment, pouchitis.
• Screen for tuberculosis and assess for active, chronic or recurrent severe infection before treatment.
• Bring immunisations up to date before initiation where possible; non-live vaccines may continue.
• Subcutaneous treatment is a maintenance formulation following initial intravenous treatment and requires injection training.
• Safety and efficacy have not been established in patients under 18; renal and hepatic impairment have not been specifically studied.
• Record the product name and batch number to maintain biological traceability.

Contraindications and cautions

• Hypersensitivity to vedolizumab or a formulation excipient.
• Active severe infection, including tuberculosis, sepsis, cytomegalovirus, listeriosis or an opportunistic infection such as progressive multifocal leukoencephalopathy.

Monitoring

• Assess for infection before, during and after treatment; consider withholding treatment if a severe infection develops.
• Monitor for new or worsening neurological symptoms; withhold treatment if PML is suspected and permanently discontinue if confirmed.
• Monitor for hypersensitivity and infusion-related reactions; intravenous treatment requires suitable observation and emergency support.
• Review clinical response and ongoing need for treatment.
• Monitor for hepatic symptoms or abnormal liver tests where clinically indicated.

Clinical pharmacology

Humanised IgG1 monoclonal antibody that selectively binds alpha-4-beta-7 integrin, inhibits interaction with MAdCAM-1 and reduces gut-homing lymphocyte migration into gastrointestinal tissue.

Formulation and product differences

• The intravenous product is a powder requiring reconstitution and dilution, administered in a suitably equipped healthcare setting; it includes the licensed pouchitis indication.
• The subcutaneous product is a single-use pre-filled syringe for ulcerative colitis or Crohn’s disease maintenance after initial intravenous treatment and may be administered by a trained patient or caregiver.
• The pre-filled syringe must be refrigerated and protected from light; one syringe may be kept protected from light at room temperature for up to seven days and must not be frozen.

Solution for infusion

Route: Intravenous

Strengths: 300 mg

Injection

Route: Parenteral

Strengths: 108 mg