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. The interaction of the α4β7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease.

ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of:

• moderately to severely active ulcerative colitis. 
• moderately to severely active Crohn’s disease.

Recommended Dosage in Adults with Ulcerative Colitis and Crohn’s Disease

• Week 0: Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes [see Dosage and Administration]. 
• Week 2: Administer ENTYVIO 300 mg by intravenous infusion 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: Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes and then every eight weeks thereafter. Subcutaneous Injection: Administer ENTYVIO 108 mg subcutaneously once every 2 weeks.
• Discontinue therapy in patients who show no 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. 

See packaging insert for full dosing information.

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.

Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

• Infusion-Related Reactions and Hypersensitivity Reactions: Discontinue ENTYVIO and initiate appropriate treatment if serious reactions occur. 
• Infections: Treatment with ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO.
• 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. ADVERSE REACTIONS Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) are: nasopharyngitis