Formulary
Vedolizumab: Indications, Dosing, Side Effects and Interactions
Vedolizumab is a monoclonal antibody that binds specifically to the 4 7 integrin, which is expressed on gut homing T helper lymphocytes and causes a...
MedNext Academy | 3 min read
Vedolizumab: Indications, Dosing, Side Effects and Interactions
Vedolizumab is a monoclonal antibody that binds specifically to the 4 7 integrin, which is expressed on gut homing T helper lymphocytes and causes a...
Drug action
Vedolizumab is a monoclonal antibody that binds specifically to the 4 7 integrin, which is expressed on gut homing T helper lymphocytes and causes a reduction in gastrointestinal inflammation.
Indications and dose
**Ulcerative colitis (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 300 mg, then 300 mg after 2 weeks, followed by 300 mg after 4 weeks, followed by 300 mg every 8 weeks, dose to be given over 30 minutes, if treatment is interrupted or response decreases, dosing frequency may be increased-consult product literature; review treatment if no response within 10 weeks of initial dose.
- **Adult** (By Subcutaneous Injection): Maintenance 108 mg every 2 weeks, following at least 2 intravenous infusions; the first subcutaneous dose should be administered in place of the next scheduled intravenous dose.
**Crohn's disease (under expert supervision)**
- **Adult** (By Intravenous Infusion): Initially 300 mg, then 300 mg after 2 weeks, followed by 300 mg after 4 weeks, followed by 300 mg every 8 weeks, dose to be given over 30 minutes, if no response is observed, an additional dose of 300 mg may be given 10 weeks after initial dose; if treatment is interrupted or response decreases, dosing frequency may be increased-consult product literature; review treatment if no response within 14 weeks of initial dose.
- **Adult** (By Subcutaneous Injection): Maintenance 108 mg every 2 weeks, following at least 2 intravenous infusions; the first subcutaneous dose should be administered in place of the next scheduled intravenous dose.
Cautions
Controlled chronic severe infection; history of recurring severe infection; previous treatment with natalizumab (wait at least 12 weeks between natalizumab use and initiation of vedolizumab unless potential benefit outweighs risk); previous treatment with rituximab Cautions, further information Risk of infection Patients must be screened for tuberculosis before starting treatment; if latent tuberculosis is diagnosed, appropriate treatment must be initiated prior to vedolizumab treatment; if tuberculosis is diagnosed during treatment, discontinue vedolizumab until infection is resolved. M Patients should be brought up to date with current immunisation schedule before initiating treatment. M
Contraindications
Severe active infection
Side effects
Common or very common Arthralgia; constipation; cough; fatigue; fever; gastrointestinal discomfort; gastrointestinal disorders; headache; hypertension; increased risk of infection; muscle spasms; muscle weakness; nasal congestion; nausea; night sweats; oropharyngeal pain; pain; paraesthesia; skin reactions Uncommon Chills; feeling cold; infusion related reaction Rare or very rare Hypersensitivity; vision blurred Frequency not known Meningitis listeria; sepsis Side-effects, further information Infusion-related and hypersensitivity reactions have been reported. Patients should be observed continuously during each infusion for signs and symptoms of acute hypersensitivity reactions; they should also be observed for 2 hours after the initial two infusions, and for 1 hour after subsequent infusions. Discontinue treatment if a severe infusion-related or other severe reaction occurs and initiate appropriate treatment (e.g. adrenaline and antihistamines); if a mild to moderate infusion-related reaction occurs, interrupt infusion or reduce infusion rate and initiate appropriate treatment (if reaction subsides the infusion may be continued)-consider pretreatment with an antihistamine, hydrocortisone, and/or paracetamol prior to subsequent infusions in patients who experience mild to moderate infusion-related reactions.
Interactions
**Other interactions (4):**
- Vedolizumab has been studied in adult ulcerative colitis and Crohn's disease patients with concomitant administration of corticosteroids, immunomodulators (azathioprine, 6mercaptopurine, and...
- Population pharmacokinetic analyses suggest that coadministration of such agents did not have a clinically meaningful effect on vedolizumab pharmacokinetics.
- The effect of vedolizumab on the pharmacokinetics of commonly coadministered medicinal compounds has not been studied.
- Vaccinations Live vaccines, in particular live oral vaccines, should be used with caution concurrently with vedolizumab (see section 4.4).
Pregnancy
Manufacturer advises use only if potential benefit outweighs risk.
Breast feeding
Specialist sources indicate use with caution-present in milk. D
Medicinal forms
Solution,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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