Entyvio® is a brand of vedolizumab. This injection treats ulcerative colitis and Crohn's disease.

Serious infection In very rare cases, Entyvio can lead to a viral infection in the brain. This is called progressive multifocal leukoencephalopathy (PML). People who already have a weak immune system are at higher risk of PML. For most people, the virus that causes this condition is nothing to worry about.

What is the most important information I should know about ENTYVIO? ENTYVIO may cause serious side effects, including: Infusion-related and serious allergic reactions. These reactions can happen while you are receiving ENTYVIO or several hours after treatment.

Entyvio (vedolizumab) is a biologic therapy approved for the treatment of ulcerative colitis and Crohn's disease. It works selectively in the gut to decrease inflammation and does not usually lead to system-wide immunosuppression.

Examples of long-term side effects that can happen with Entyvio include:

• serious infection, which may lead to sepsis (a serious, life threatening response to infection that can cause organ damage)
• liver problems, such as hepatitis (inflammation of the liver)
• certain cancers*

The most common side effects of ENTYVIO include: common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO.

Long-term use of Entyvio was shown to be safe and effective in patients with moderate-to-severe ulcerative colitis and Crohn's disease through 5 years, according to interim results from the ongoing GEMINI open-label long-term safety study presented at the 12th Congress of the European Crohn's and Colitis Organization.

You may receive "killed-virus" vaccines such as a flu shot, polio vaccine, rabies vaccine, or hepatitis A vaccine. Ask your doctor before receiving any vaccine while you are being treated with Entyvio. Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Yes, Entyvio is meant to be used as a long-term treatment. How long you'll receive Entyvio depends depends on whether the drug is working to manage the symptoms of your condition. If you and your doctor determine that Entyvio is safe and effective for you, it's likely that you'll be given it long term.

You may see some symptom relief after your first dose of Entyvio. But it may take several weeks for you to be free of symptoms. If you don't have significantly reduced symptoms by week 14 of treatment, your doctor will likely have you stop taking Entyvio.