Vedolizumab

Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Vedolizumab does not bind to or inhibit function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1).

• ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD).ICD-10: K50.90, K51.90

• ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see Warnings and Precautions (5.1) ] . Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.contraindicated

Important Administration Information Before Initiating ENTYVIO Consider evaluating patients for tuberculosis (TB) infection. ( 2.1 , 5.2 ) Update immunizations according to current immunization guidelines. ( 2.1 , 5.5 ) Intravenous Administration : ENTYVIO should be administered intravenously by a healthcare provider. ( 2.1 ) Subcutaneous Injection : ENTYVIO prefilled syringe and ENTYVIO PEN are intended for subcutaneous use. A patient may self-inject or caregiver may inject after proper training on correct subcutaneous injection technique. ( 2.1 ) Recommended Dosage ( 2.2 ) Week 0 : 300 mg infused intravenously over approximately 30 minutes. Week 2 : 300 mg infused intravenously over approximately 30 minutes. Week 6 : Patients may remain on ENTYVIO intravenous therapy or switch to subcutaneous injection after receiving two ENTYVIO intravenous doses administered at Week 0 and Week 2. Intravenous Infusion : 300 mg infused over approximately 30 minutes and then every eight weeks thereafter. Subcutaneous Injection : 108 mg subcutaneously once every two weeks. Discontinue ENTYVIO in patients who do not show evidence of therapeutic benefit by Week 14. Patients currently receiving and responding to ENTYVIO intravenous therapy after Week 6 may also be switched to subcutaneous injection. Administer the first subcutaneous dose in place of the next scheduled intravenous infusion and every two weeks thereafter. Preparation and Administration Instructions: See full prescribing information for complete information on reconstitution, dilution, administration, and storage.

Infusion-Related Reactions and Hypersensitivity Reactions : Discontinue ENTYVIO and initiate appropriate treatment if serious reactions occur. ( 5.1 ) Infections : Treatment with ENTYVIO should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, ENTYVIO should not be administered until the infection resolves. ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML) : Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. ( 5.3 ) 5.1 Infusion-Related Reactions and Hypersensitivity Reactions Infusion-related reactions and hypersensitivity reactions have been reported, including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate [see Adverse Reactions (6.1 , 6.2) ]. These reactions may occur with the first or subsequent infusions of ENTYVIO and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment. 5.2 Infections Patients treated with ENTYVIO are at increased risk for developing infections [see Adverse Reactions (6.1) ]. Serious infections reported in clinical trials include anal abscess, sepsis (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis.

The following topics are also discussed in detail in the Warnings and Precautions section: Infusion-Related Reactions and Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.3) ] Liver Injury [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) are: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities. ( 6.1 ) Adverse reactions with subcutaneous ENTYVIO are similar to those reported with intravenous ENTYVIO with the exception of injection site reactions reported with subcutaneous ENTYVIO. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to intravenous ENTYVIO in 3,326 patients and healthy volunteers in clinical trials, including 1,396 exposed for greater than one year, and 835 exposed for greater than two years.

8.1 Pregnancy Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby ENTYVIO Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not reliably identified an ENTYVIO-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ) . There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy (see Clinical Considerations ) . No fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage (see Data ) . The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and miscarriage is 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity.

Metabolism

Similar pharmacokinetics were observed in ulcerative colitis and Crohn's disease patients administered 300 mg ENTYVIO as a 30-minute intravenous infusion on Weeks 0, 2, and 6, and then every eight weeks up to Week 52 (Table 3) . Table 3.

• May 20, 2014BLABLA125476Takeda Pharms Usa
• Sep 27, 2023BLABLA761133Takeda Pharms Usa

1. 1Off Label Use22,12426%
2. 2Colitis Ulcerative15,24318%
3. 3Crohn^s Disease11,11113%
4. 4Drug Ineffective9,69512%
5. 5Diarrhoea8,48810%
6. 6Abdominal Pain7,2748.7%
7. 7Fatigue6,1617.4%
8. 8Haematochezia5,9877.2%
9. 9Frequent Bowel Movements5,1326.1%
10. 10Arthralgia4,6125.5%
11. 11Malaise4,2285.1%
12. 12Nausea4,0534.9%
13. 13Headache4,0244.8%
14. 14Inappropriate Schedule Of Product Administration3,8954.7%
15. 15Product Dose Omission Issue3,6774.4%

The 10 most recently updated of 213 ClinicalTrials.gov registrations naming Vedolizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
  Recruiting · Phase 4 · Interventional · 400 enrolled · Takeda
  NCT06581328updated 2026-06-10
• A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
  Active not recruiting · Phase 3 · Interventional · 573 enrolled · AbbVie
  NCT06880744updated 2026-06-03
• PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure
  Not yet recruiting · Phase 2 · Interventional · 112 enrolled · Therakos LLC
  NCT07619898updated 2026-06-02
• A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
  Recruiting · Phase 3 · Interventional · 396 enrolled · Takeda
  NCT06227910updated 2026-05-27
• A Study in Adults With Inflammatory Bowel Disease (IBD) Receiving Vedolizumab in the Patient Support Program (PSP) in Brazil
  Active not recruiting · Observational · 1,006 enrolled · Takeda
  NCT05626088updated 2026-05-26
• Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis
  Active not recruiting · Phase 3 · Interventional · 392 enrolled · Takeda
  NCT03221036updated 2026-05-22
• A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
  Recruiting · Phase 3 · Interventional · 70 enrolled · Takeda
  NCT06100289updated 2026-05-15
• Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
  Active not recruiting · Observational · 4,000 enrolled · Pfizer
  NCT07177209updated 2026-05-14
• Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
  Completed · Phase 2 · Interventional · 59 enrolled · Takeda
  NCT03196427updated 2026-05-13
• FirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled Trial
  Not yet recruiting · Phase 4 · Interventional · 240 enrolled · University Hospital, Clermont-Ferrand
  NCT07576452updated 2026-05-13

Frequently asked questions

How does Vedolizumab work?

Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Vedolizumab does not bind to or inhibit function of the α4β1 and αEβ7 integrins and does not antagonize the interaction of α4 integrins with vascular cell adhesion molecule-1 (VCAM-1).

What is Vedolizumab used for?

According to FDA labeling, Vedolizumab carries indications including: ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Vedolizumab?

Vedolizumab is classified as Monoclonal antibodies, Integrin Receptor Antagonist, Integrin Receptor Antagonists, Decreased Adhesion Factor Activity.

What are the brand names for Vedolizumab?

Vedolizumab is marketed under brand names including Entyvio.

What are the contraindications for Vedolizumab?

Vedolizumab labeling lists contraindications including: ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see Warnings and Precautions (5.1) ] . Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.. Always consult the full prescribing information and a clinician.