Vedolizumab
Pronunciation: VED-oh-LIZ-oo-mab.
- Generic name
- vedolizumab
- Drug class
- Gut-selective integrin receptor antagonist (biologic monoclonal antibody) -- NOT a TNF (tumour necrosis factor) inhibitor
- Form
- 300 mg powder for concentrate for solution for infusion (IV vial); 108 mg/0.68 mL solution for injection (prefilled syringe or pen, subcutaneous)
- Route
- Intravenous infusion or subcutaneous injection
- Legal status
- Prescription-only medicine, administered under medical supervision
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Entyvio (5), Entyvio (SC pre-filled syringe) (5), Entyvio/Kynteles (chronic pouchitis indication) (5) · Full directory
What vedolizumab is and how it works
Vedolizumab is a biologic medicine (a humanized monoclonal antibody) given by intravenous infusion or, for maintenance, by subcutaneous injection. It is used to treat moderately to severely active ulcerative colitis and Crohn's disease -- two forms of inflammatory bowel disease -- in adults who have not responded well enough to, have lost response to, or cannot tolerate conventional therapy or a TNF-alpha-inhibitor biologic. In the UK and Australia, it is also used for chronic pouchitis after certain ulcerative colitis surgery. (1) (7)
Vedolizumab works differently from many other biologic IBD treatments: it specifically blocks a protein called the alpha-4-beta-7 integrin on certain white blood cells, stopping them from moving into the gut lining and causing inflammation there. This makes it 'gut-selective' -- it is NOT a TNF inhibitor (unlike infliximab, adalimumab, or etanercept) and works through a different mechanism. It does not carry a US boxed warning, but it does carry real precautions: infusion reactions and allergic-type reactions, an increased risk of serious infections (patients are screened for tuberculosis first), a monitoring requirement for a rare brain infection called progressive multifocal leukoencephalopathy (PML) -- a precaution shared with a related but different drug class, even though no confirmed case of PML has been reported specifically with vedolizumab -- and a warning about liver injury. Anyone considering vedolizumab should discuss their personal infection history and risk factors with their treating clinician before starting.
Mechanism of action: how vedolizumab works
Vedolizumab is a humanized IgG1 monoclonal antibody that binds specifically to the alpha-4-beta-7 integrin, inhibiting its interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and thereby blocking migration of memory T-lymphocytes into gastrointestinal parenchymal tissue. It does not bind alpha-4-beta-1 or alpha-E-beta-7 integrins and has no direct effect on TNF-alpha signalling, distinguishing it mechanistically from TNF-inhibitor biologics. (1) (2)
What vedolizumab is used for
Moderately to severely active ulcerative colitis
Used in adults with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or cannot tolerate conventional therapy or a TNF-alpha-inhibitor biologic. (1) (2) (3)
Moderately to severely active Crohn's disease
Used in adults with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or cannot tolerate conventional therapy or a TNF-alpha-inhibitor biologic. (1) (2) (3)
Chronic pouchitis (UK and Australia only)
In the United Kingdom and Australia, vedolizumab is additionally approved for moderately to severely active chronic pouchitis in adults who have had proctocolectomy and ileal pouch-anal anastomosis for ulcerative colitis, and who have had an inadequate response to or lost response to antibiotic therapy. This indication is not part of the current US FDA label. (2) (5)
Before taking vedolizumab
Do not take / not appropriate for
- Do not have vedolizumab if you have had a known serious or severe allergic (hypersensitivity) reaction to vedolizumab or any of its ingredients. (all countries) (1)
- In the UK and EU, vedolizumab is also contraindicated if you have an active severe infection such as tuberculosis, sepsis, cytomegalovirus, listeriosis, or an opportunistic infection such as PML -- this is a stricter, hard contraindication in these markets, versus a caution/monitoring-level warning in the current US label. (United Kingdom, European Union) (2)
Tell your clinician about
- Any current infection, or history of serious or recurrent infections, including tuberculosis.
- Any history of an allergic reaction during a previous infusion.
- Any history of liver problems or symptoms such as jaundice (yellowing of skin/eyes).
- Any new or unusual neurological symptoms (confusion, vision changes, weakness, difficulty speaking) -- both before starting and at any point during treatment.
- Whether you are pregnant, could become pregnant, or are breastfeeding.
- Whether you have received or are due to receive any vaccinations, especially live vaccines.
- All other medicines you take, especially other biologic therapies such as natalizumab or TNF-alpha inhibitors.
How to take vedolizumab
- Vedolizumab is given by a doctor or nurse, either as an intravenous (IV) infusion into a vein (over about 30 minutes) or, for maintenance therapy in some patients, as a subcutaneous (under-the-skin) injection.
- You will be observed during and for a period after your first infusions in case of an infusion-related reaction.
- Never adjust your own dose, frequency, or route of administration -- this is managed entirely by your treating clinical team based on your response to treatment.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)
Missed dose
If you miss a scheduled infusion or injection appointment, contact your clinical team as soon as possible to reschedule -- do not decide on your own when to resume or how to adjust your next dose.
Overdose
Vedolizumab is given under direct medical supervision, so an overdose in the usual sense is unlikely. If you experience any unusual or severe symptoms after an infusion or injection, contact your clinical team or seek urgent medical attention. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Nasopharyngitis (common cold-type symptoms).
What to notice: Nasopharyngitis (common cold-type symptoms).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Headache.
What to notice: Headache.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Joint pain (arthralgia).
What to notice: Joint pain (arthralgia).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Nausea.
What to notice: Nausea.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Fever (pyrexia), fatigue, cough, upper respiratory tract infection.
What to notice: Fever (pyrexia), fatigue, cough, upper respiratory tract infection.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Injection-site reactions (with the subcutaneous formulation).
What to notice: Injection-site reactions (with the subcutaneous formulation).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of an infusion-related or allergic (hypersensitivity) reaction — high caution
Symptoms: Difficulty breathing, wheezing, swelling of the face/lips/throat, hives or widespread rash, flushing, or a sudden increase in heart rate or blood pressure -- during the infusion or up to several hours afterward.
Action: Tell the infusion team immediately if any of these symptoms occur -- the infusing clinical team will assess and, if needed, slow, pause, or stop the infusion and treat the reaction. (1) (2)
Signs of a serious infection — high caution
Symptoms: Fever, chills, persistent cough, unexplained weight loss, night sweats, or any infection that does not improve.
Action: Contact your clinical team promptly -- vedolizumab increases the risk of infections, including rare but serious cases of sepsis and tuberculosis reactivation. Do not stop or continue treatment on your own; your clinician will decide whether treatment needs to be paused. (1) (2)
New or worsening neurological symptoms (possible sign of PML) — high caution
Symptoms: New confusion, memory problems, difficulty speaking or understanding speech, vision changes, weakness on one side of the body, or a change in the way you walk.
Action: Contact your clinical team promptly to be assessed for progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection linked to this class of medicine. No confirmed case of PML has been reported specifically with vedolizumab to date, but monitoring for these symptoms is a genuine, ongoing safety requirement -- do not dismiss new neurological symptoms. (1) (7)
Signs of liver injury — high caution
Symptoms: Yellowing of the skin or eyes (jaundice), dark urine, severe fatigue, or right-sided abdominal pain.
Action: Contact your clinical team promptly -- these can be signs of liver injury, and your clinician may need to evaluate whether treatment should continue. (1)
Interactions
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Pregnancy exposure data reviewed to date have not shown an increased risk of major birth defects, but vedolizumab should only be used in pregnancy if the potential benefit justifies the potential risk, and only under specialist guidance -- it is a large-molecule biologic that crosses the placenta increasingly as pregnancy progresses. (1) (2) (3) (4) (5) (6) (7)
Breastfeeding
Vedolizumab has been detected in human milk; systemic exposure for a breastfed infant is expected to be low, but discuss the benefits and risks with your clinician before breastfeeding while on treatment. (1) (2) (3) (4) (5) (6) (7)
Children
Not approved for use in children; safety and effectiveness in pediatric patients have not been established by Health Canada or the other regulator sources reviewed. (1) (2) (3) (4) (5) (6) (7)
Elderly
No specific dose adjustment identified for older adults in the sources reviewed; general infection-risk vigilance applies as for any patient. (1) (2) (3) (4) (5) (6) (7)
Hepatic_impairment
Your clinical team will stop treatment if jaundice or other evidence of significant liver injury develops; specific dose-adjustment data for hepatic impairment were not identified in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6) (7)
Renal_impairment
Specific dose-adjustment data for renal impairment were not identified in the sources reviewed for this dossier -- discuss with your clinician if this applies to you. (1) (2) (3) (4) (5) (6) (7)
Source_ids
US-DAILYMED-ENTYVIO-2026,CA-HEALTHCANADA-ENTYVIO-PM-2026 (1) (2) (3) (4) (5) (6) (7)
Monitoring
Before starting
- Screening for active tuberculosis
- Current infection status
- Liver function
- Vaccination history
- Pregnancy/breastfeeding status
During treatment
- Observation during and for a period after infusions for signs of an infusion-related reaction.
- Ongoing vigilance for signs of infection, new neurological symptoms, or liver injury -- report any of these to your clinical team promptly (see serious warnings above).
Storage
Vedolizumab is stored and prepared by pharmacy/clinical staff under refrigeration according to the product label; subcutaneous prefilled syringes/pens for home use should be stored and handled exactly as instructed by your pharmacist or nurse, and kept out of reach of children.
Professional information
Clinician-facing context only, sourced from the current US FDA prescribing information and UK/EU regulator sources reviewed for this dossier; verify against the current full label before prescribing.
United States
Indication: Moderately to severely active ulcerative colitis and Crohn's disease (adults)
Dose summary: IV: 300 mg at weeks 0, 2, 6, then every 8 weeks. SC maintenance: 108 mg every 2 weeks after at least 2 IV doses.
Renal context: No specific renal dose-adjustment identified in the US label reviewed. (1)
United Kingdom / European Union
Indication: Moderately to severely active ulcerative colitis, Crohn's disease, and (UK only) chronic pouchitis
Dose summary: 300 mg IV at weeks 0, 2, 6, then every 8 weeks; frequency increase to every 4 weeks may be considered for reduced response.
Renal context: Not specifically dose-adjusted in the UK/EU sources reviewed. (2) (3)
Hepatic guidance
Treatment is stopped by the clinical team if jaundice or other evidence of significant liver injury develops; no formal hepatic-impairment dosing study identified in the sources reviewed.
Overdose note
Administered under direct medical supervision; no specific overdose management protocol beyond supportive care and monitoring was identified in the sources reviewed. (1) (2)
Frequently asked questions
Is vedolizumab a TNF inhibitor, like infliximab or adalimumab?
No. Vedolizumab works through a different mechanism -- it specifically blocks the alpha-4-beta-7 integrin on certain white blood cells, stopping them from moving into the gut lining. This makes it 'gut-selective.' It does not inhibit TNF-alpha at all, so it is mechanistically distinct from TNF-inhibitor biologics such as infliximab, adalimumab, or etanercept. (1) (3)
Does vedolizumab cause PML (progressive multifocal leukoencephalopathy)?
PML is a genuine, label-mandated monitoring requirement for vedolizumab, because it belongs to the same broad drug class (integrin antagonists) as natalizumab, a different medicine with confirmed PML cases. However, no confirmed case of PML has been reported specifically with vedolizumab to date, despite a dedicated safety-monitoring programme designed to detect it. Patients are still asked to report any new or worsening neurological symptoms promptly, because this is an ongoing precaution, not a resolved question. (1) (7)
Is vedolizumab available everywhere?
Yes -- it is authorised and currently supplied in the US, UK, EU, Canada, Australia, and New Zealand (funded by PHARMAC since 1 February 2023, subject to Special Authority approval criteria). The UK and Australia additionally cover a third indication, chronic pouchitis after certain ulcerative colitis surgery, which is not currently part of the US label. (6) (2) (5)
What is the mechanism of action of vedolizumab?
Vedolizumab is a humanized IgG1 monoclonal antibody that binds specifically to the alpha-4-beta-7 integrin, inhibiting its interaction with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and thereby blocking migration of memory T-lymphocytes into gastrointestinal parenchymal tissue. It does not bind alpha-4-beta-1 or alpha-E-beta-7 integrins and has no direct effect on TNF-alpha signalling, distinguishing it mechanistically from TNF-inhibitor biologics. (1) (2)
References
- ENTYVIO (vedolizumab) for injection, IV use; injection, SC use; ENTYVIO PEN -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Takeda Pharmaceuticals · United States · accessed 2026-07-31 · source 1
- Entyvio 300 mg powder for concentrate for solution for infusion -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Takeda UK Ltd · United Kingdom · accessed 2026-07-31 · source 2
- Entyvio, INN-vedolizumab -- EPAR (EMEA/H/C/002782)European Medicines Agency (EMA) -- centralised EU marketing authorisation, EPAR · European Union · accessed 2026-07-31 · source 3
- ENTYVIO (vedolizumab) -- Product MonographHealth Canada product monograph, Takeda Canada Inc. · Canada · accessed 2026-07-31 · source 4
- ENTYVIO vedolizumab 300 mg powder for injection vial (ARTG 210048); 108 mg/0.68 mL pre-filled syringe (ARTG 317261)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-31 · source 5
- Decision to fund vedolizumab for inflammatory bowel diseasePHARMAC (Pharmaceutical Management Agency), New Zealand -- official funding decision · New Zealand · accessed 2026-07-31 · source 6
- A Programme for Risk Assessment and Minimisation of Progressive Multifocal Leukoencephalopathy Developed for Vedolizumab Clinical TrialsPeer-reviewed literature (PMC/PubMed) -- PML risk assessment and minimisation programme developed for vedolizumab clinical trials · International (clinical trial safety monitoring) · accessed 2026-07-31 · source 7
Brand names by country
Single-ingredient vedolizumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Entyvio108 mg/.68mL, 300 mg/5mL · takeda pharmaceuticals america, inc.
United Kingdom
- Entyvio (2)MHRA licensed emc smpc confirmed broader indication includes pouchitis · 300 mg (IV vial), 108 mg (SC prefilled syringe/pen) · Takeda Pharma A/S (PLGB 15475/0044)
Canada
- ENTYVIO
Australia
- Entyvio (5)TGA ARTG registered 2014-06-27 confirmed 300mg vial · 300 mg (IV vial) · Takeda Pharmaceuticals Australia Pty Ltd
- Entyvio (SC pre-filled syringe) (5)TGA ARTG registered 2020-05-12 confirmed · 108 mg/0.68 mL · Takeda Pharmaceuticals Australia Pty Ltd
- Entyvio/Kynteles (chronic pouchitis indication) (5)TGA ARTG registered 2023-06-29 confirmed third indication · 300 mg · Takeda Pharmaceuticals Australia Pty Ltd
New Zealand
- Entyvio (6)PHARMAC funded since 2023-02-01 special authority required medsafe datasheet indexed not live fetched · 300 mg (IV vial) · Takeda (PHARMAC-funded, Special Authority criteria apply)
View brands in additional countries.
European Union
Entyvio (3)