What You Need to Know About Entyvio (Vedolizumab)

Entyvio (vedolizumab) is a gut-homing α4β7 integrin antagonist that works to treat the two main forms of inflammatory bowel disease (IBD). Entyvio works by binding to the α4β7 integrin, which stops the integrin from further contributing to the inflammation in the digestive system that is associated with IBD. Entyvio is currently approved to treat moderate to severe Crohn's disease or moderate to severe ulcerative colitis. Entyvio was developed by, and is marketed by, Takeda Pharmaceuticals.

• People who have an infection should not receive Entyvio.
• A tuberculosis (TB) test should be given before starting Entyvio.
• Vaccinations should be up-to-date before starting, and no live vaccinations should be given, during treatment with Entyvio.
• Entyvio is given intravenously, with 3 starting doses, and every 8 weeks thereafter.
• It is not known how Entyvio will affect a growing fetus or a breastfeeding infant.

Entyvio is given by infusion, either at a doctor's office, hospital, or infusion center. When treatment first begins, Entyvio is given in three starting infusions: the first infusion, followed by another infusion 2 weeks later, and a third 4 weeks after that (the total elapsed time is 6 weeks). After that third infusion, Entyvio is then given about every 8 weeks. Each infusion takes about half an hour. The physician prescribing Entyvio will give any special instructions to follow before and after infusions.

Entyvio is available to treat patients with moderate to severe cases of both of the major forms of IBD (Crohn's disease and ulcerative colitis). Entyvio is typically used only after other medications for IBD have been tried and are not working to manage symptoms. Entyvio is not approved to treat children under the age of 18. If treatment is effective, people taking Entyvio may find their signs and symptoms of IBD abate, and they could achieve a period of remission.

Tell your doctor if you have ever had any of the following conditions:

• Allergic reactions to any medication
• Are breastfeeding
• Are currently pregnant or trying to become pregnant
• Liver disease
• Infections
• Recent vaccination
• Tuberculosis (TB)

According to the prescribing information from Takeda Pharmaceuticals, the most common side effects of Entyvio include the common cold (nasopharyngitis), headache, joint pains, nausea, fever, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. Tell your doctor if any side effects are bothersome or don't go away.

Rarely other, more serious side effects can occur, such as allergic reactions that could lead to anaphylaxis. An increased risk of infection is also a concern, and infections have been reported in patients who received Entyvio. Side effects, especially any that could indicate an allergic reaction or an infection, should be reported to the prescribing physician right away.

Entyvio has not yet been extensively studied for drug interactions. Tell your doctor if you are taking Tysabri (natalizumab), a tumor necrosis factor alpha blocker, immunosuppresants, or corticosteroids. Always tell your doctor about all medications and supplements you are taking.

There are no known food interactions.

The FDA has classified Entyvio as a type B drug. The effect that Entyvio has on an unborn child has not been studied extensively. Entyvio should only be used during pregnancy if clearly needed. Notify the prescribing doctor if you become pregnant while taking Entyvio. It is not known if Entyvio passes into breast milk. The potential for serious side effects in an infant should be weighed against the usefulness of the medication to the mother. Another option is to discontinue breastfeeding before administering Entyvio.

Entyvio was approved in 2014, and therefore not much is known yet about its long-term use. A review of six trials of Entyvio that took place over a period of 4 years showed that the drug has a favorable safety profile.