Molecule
Vedolizumab is an integrin receptor antagonist indicated in adults for the treatment of moderately to severely active ulcerative colitis (UC). It is available as injection and powder for injection for subcutaneous and intravenous use. MedsAcross supplies Vedolizumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD). ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis (UC). moderately to severely active Crohn's disease (CD).
Source: US FDA prescribing information
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). The α4β7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue.
Source: US FDA prescribing information
Important Administration Information Before Initiating ENTYVIO Consider evaluating patients for tuberculosis (TB) infection. Update immunizations according to current immunization guidelines. Intravenous Administration: ENTYVIO should be administered intravenously by a healthcare provider. 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. Recommended Dosage. 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.
Source: US FDA prescribing information
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). Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
Source: US FDA prescribing information
Infusion-Related Reactions and Hypersensitivity Reactions: Discontinue ENTYVIO and initiate appropriate treatment if serious reactions occur. 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. 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.
Source: US FDA prescribing information
The following topics are also discussed in detail in the Warnings and Precautions section: Infusion-Related Reactions and Hypersensitivity Reactions Infections Progressive Multifocal Leukoencephalopathy Liver Injury 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. Adverse reactions with subcutaneous ENTYVIO are similar to those reported with intravenous ENTYVIO with the exception of injection site reactions reported with subcutaneous ENTYVIO.
Source: US FDA prescribing information
Natalizumab Products Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products.
Source: US FDA prescribing information
Refrigerate ENTYVIO unopened vials, prefilled syringes, and prefilled pens at 2°C to 8°C (36° to 46°F). If needed, the ENTYVIO prefilled syringe or ENTYVIO PEN can be left out of the refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling). Do not use ENTYVIO prefilled syringe or ENTYVIO PEN if left out of the refrigerator for more than 7 days. Do not freeze ENTYVIO vial, prefilled syringe, or prefilled pen. Do not shake the ENTYVIO prefilled syringe or ENTYVIO PEN. Retain in original package to protect from light until the time of use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Vedolizumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Entyvio 108 mg/0.68 mL injectionSubcutaneous Cold chain | Takeda Pharmaceuticals | US FDA | Available on request |
| Entyvio 300 mg/5 mL powder for injectionIntravenous Cold chain | Takeda Pharmaceuticals | US FDA | Available on request |
| ENTYVIO Pen 108 mg/0.68 mL injectionSubcutaneous Cold chain | Takeda Pharmaceuticals | US FDA | Available on request |
2 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Vedolizumab in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 3 presentations of Vedolizumab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Vedolizumab, including Entyvio, ENTYVIO Pen.
Yes. The US FDA first approved Vedolizumab on 20 May 2014, according to Drugs@FDA.
Yes. Vedolizumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Vedolizumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Vedolizumab is classified under ATC code L04AA33 (Vedolizumab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.