Vedolizumab
Vedolizumab is a humanized monoclonal antibody that targets the α4β7 integrin on T-cells, preventing these immune cells from migrating into the gastrointestinal tract. By blocking this migration, it reduces intestinal inflammation in patients with inflammatory bowel diseases. It is primarily used to treat adults with moderate to severe ulcerative colitis and Crohn's disease who have not responded adequately to conventional therapies.
Vedolizumab is an immunosuppressant monoclonal antibody that treats inflammatory bowel diseases by blocking immune cell migration to the gut.
Key facts at a glance
- ATC
- L04AG05
- RxNorm
- 1538097
- Generic
- Vedolizumab
- Class
- atc-l04
- Brands
- Entyvio
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe, injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus
regular prenatal care and fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second and third trimesteravoid if possible
continue only if clearly needed, consider discontinuing near delivery
fetal growth monitoring in third trimester
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot recommended
breastfeeding not recommended during treatment with vedolizumab
monitor infant for infections
Use with caution and monitor for adverse effects.
pediatric_age
under 18 yearsnot approved
not indicated for patients under 18 years of age
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly over 65no adjustment needed
use with caution, start at standard dosing
monitor for infections and overall clinical response
Use with caution and monitor for adverse effects.
renal_impairment
any stageno adjustment needed
no dosage adjustment required for any degree of renal impairment
routine monitoring
hepatic_impairment
mild to moderateno adjustment needed
no dose adjustment required, limited data available
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
severeuse with caution
use only if benefits outweigh risks, limited data available
close monitoring of liver function
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Initial FDA approval date for Vedolizumab (Entyvio)
Drug class
Monoclonal antibody that targets alpha-4-beta-7 integrin
Approved indications
Therapeutic indications approved by FDA
Mechanism of action
Binds to alpha-4-beta-7 integrin, blocking lymphocyte migration to gastrointestinal tract
Treatment of moderate to severe ulcerative colitis and Crohn's disease in adult patients who have had an inadequate response with, lost response to, or were intolerant to conventional therapies or a tumor necrosis factor (TNF) antagonist.
Vedolizumab is a monoclonal antibody that specifically binds to the α4β7 integrin and blocks its interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM-1), thereby inhibiting the migration of memory T-lymphocytes across the endothelium into inflamed intestinal tissue.
Administered as an intravenous infusion. May increase risk of infections, including serious and opportunistic infections. Hypersensitivity reactions can occur during or after infusion. Live vaccines should be avoided during treatment. Pregnancy category A - use during pregnancy only if clearly needed.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy