ENTYVIO is a prescription medicine used in adults for the treatment of:

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

It is not known if ENTYVIO is safe and effective in children under 18 years of age.

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. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
• Infections. ENTYVIO may increase your risk of getting a serious infection. Before receiving ENTYVIO and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
• Progressive Multifocal Leukoencephalopathy (PML). People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
• Liver Problems. Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, or yellowing of the skin and eyes (jaundice).

See "What are the possible side effects of ENTYVIO?" for more information about side effects.

Please see additional Important Safety Information below.

Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of the ingredients in ENTYVIO.

Please see additional Important Safety Information below.

Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection, think you may have an infection or have infections that keep coming back (see "What is the most important information I should know about ENTYVIO?").
• have liver problems.
• have tuberculosis (TB) or have been in close contact with someone with TB.
• have recently received or are scheduled to receive a vaccine. Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with ENTYVIO.
• are pregnant or plan to become pregnant. It is not known if ENTYVIO will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving ENTYVIO.
  • Pregnancy Registry: There is a pregnancy registry for women who use ENTYVIO during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry or you may contact the registry at 1-877-825-3327 to enroll.
• are breastfeeding or plan to breastfeed. ENTYVIO can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ENTYVIO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take or have recently taken Tysabri (natalizumab), a Tumor Necrosis Factor (TNF) blocker medicine, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take or have recently taken Tysabri (natalizumab), a Tumor Necrosis Factor (TNF) blocker medicine, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine.

ENTYVIO may cause serious side effects, see "What is the most important information I should know about ENTYVIO?".

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 of the possible side effects of ENTYVIO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• ENTYVIO is given through a needle placed in a vein (intravenous infusion) in your arm.
• ENTYVIO is given to you over a period of about 30 minutes.
• Your healthcare provider will monitor you during and after the ENTYVIO infusion for side effects to see if you have a reaction to the treatment.

You will get 30 minutes of infusion every 8 weeks. That's about 6 doses per year after a starting regimen.

You will be given a starting regimen of 3 ENTYVIO infusions starting with the initial infusion and then at week 2 and week 6. ENTYVIO is given through a needle placed in a vein (intravenous infusion) in your arm. After that, treatments are given every 8 weeks to help with disease control.

ENTYVIO is administered by a healthcare provider, either at your healthcare provider's office or at an infusion center. Your healthcare provider will monitor you during and after the ENTYVIO infusion for side effects to see if you have a reaction to the treatment.

Your healthcare provider will assess your response to therapy and need for continued treatment.

Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with ENTYVIO.

Please see additional Important Safety Information below.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if ENTYVIO will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving ENTYVIO.

• Pregnancy Registry: There is a pregnancy registry for women who use ENTYVIO during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry or you may contact the registry at 1-877-825-3327 to enroll.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. ENTYVIO can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ENTYVIO.

Please see additional Important Safety Information below.