Brand Name: Entyvio 
Generic Name: vedolizumab

Drug Class: Integrin Receptor Antagonist    
Manufacturer:  Takeda Pharmaceuticals  
Approval Date: May 2014

What is Entyvio and its mechanism of action?

Entyvio is a prescription drug used to treat both ulcerative colitis and Crohn's disease. Ulcerative colitis and Crohn's disease are inflammatory bowel diseases that affect the lining of the intestinal system. Crohn’s disease has more severe symptoms than ulcerative colitis. Entyvio is an antibody produced in Chinese hamsters. Entyvio is an integrin receptor antagonist that binds to the alpha-4 subunit on the integrin of T-lymphocytes. T-lymphocytes are white blood cells and are part of the immune system. They contribute to inflammation seen in both Crohn's disease and ulcerative colitis. By binding to the subunit, Entyvio inhibits the migration of T-lymphocyte into the intestinal tissue, reducing inflammation the intestine.  

What does Entyvio Treat?

Entyvio is FDA approved to treat Moderate to severe ulcerative colitis (UC) and Crohn's disease (CD) in patients who had an inadequate response, lost response, or were intolerant to previous treatments with TNF-inhibitors, immunomodulators or corticosteroids. In both UC and CD, Entyvio may induce (help with symptoms) and maintain non-steroid dependent clinical remission. This means that Entyvio can reduce the need for steroid treatment. 

What are warnings and precautions for Entyvio?

Who should not use Entyvio:

• Patients with active and severe infection should consider withholding Entyvio in order to prevent further development of infections such as urinary tract, upper respiratory, and sinus infections.
• Patients who have had allergic reaction to Entyvio or any of the inactive substance in Entyvio
• Treatment with Entyvio increases the risk of infection with JC virus resulting in multifocal leukoencephalopathy (PML) and even death. Therefore, patients must be monitored for any symptoms related to the nervous system.

Pregnancy: Pregnancy category B. It is not known if Entyvio will cause any harm to the fetus. Women exposed to Entyvio during pregnancy can be registered in the pregnancy exposure registry to monitor the outcomes of exposure during pregnancy. They may obtain more information about the registry by calling 1- 877-TAKEDA7 (1-877-825-3327).

Nursing Mothers: Detection of Entyvio in mother’s milk and safety of use in pediatrics have not been determined.

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