Vedolizumab

What it is and how it works

Mechanism of Action 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.

Mechanism class: Integrin Receptor Antagonists

Indications

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).

Dosage and administration (summary)

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. 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.

Contraindications

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.

Warnings and precautions

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.

Pregnancy

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 ) .…

Storage and supply

Storage and Handling 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).

Source: Vedolizumab (Entyvio) — US FDA prescribing information, 2026-04-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.