About ENTYVIO Relief & Remission within Reach Individual Results May Vary

Questions & Answers

Here are answers to a few questions you may have about ENTYVIO. Remember that you should talk to your healthcare provider about information that's more specific to you.

What is ENTYVIO?

ENTYVIO is a prescription medicine used in adults:

  • with moderately to severely active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, induce and maintain remission, reduce or stop the use of corticosteroids, and improve the way the lining of your large intestine looks to your healthcare provider.
  • with moderately to severely active Crohn's disease (CD) when certain other CD medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, achieve remission, and reduce or stop the use of corticosteroids.

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

What is the most important information I should know about ENTYVIO?

ENTYVIO may cause serious side effects, including:

  • Infusion 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). Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML. 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 abdomen, dark urine, or yellowing of the skin and eyes (jaundice).

Please see additional Important Safety Information below.

Who shouldn't receive ENTYVIO?

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

The active ingredient in ENTYVIO is vedolizumab. The inactive ingredients are L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, and polysorbate 80.

Please see additional Important Safety Information below.

What important information should I share with my healthcare provider before starting ENTYVIO?

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.
  • are breastfeeding or plan to breastfeed. It is not known if ENTYVIO passes into your breast milk.

Please see additional Important Safety Information below.

Can I receive ENTYVIO if I'm taking other medications?

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.

What are the possible side effects of ENTYVIO?

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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see additional Important Safety Information below.

How will I receive ENTYVIO?

  • 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.

How often will I need to receive ENTYVIO?

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.

Can I get vaccinated while being treated with ENTYVIO?

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

Please see additional Important Safety Information below.

Can I receive ENTYVIO if I get pregnant or if I'm breastfeeding?

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. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if ENTYVIO passes into your breast milk.

Please see additional Important Safety Information below.

Important Safety Information about ENTYVIO® (vedolizumab)

  • Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
  • ENTYVIO may cause serious side effects, including:
    • Infusion and serious allergic 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 immediate medical help 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).
    • ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or 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.
    • Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML, which 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 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 abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
  • 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. Call your healthcare provider for medical advice about side effects.
  • Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; 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; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Uses of ENTYVIO® (vedolizumab)

ENTYVIO is a prescription medicine used in adults:

  • with moderate to severe ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, induce and maintain remission, reduce or stop the use of corticosteroids, and improve the way the lining of your large intestine looks to your healthcare provider.
  • with moderate to severe Crohn's disease (CD) when certain other CD medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, achieve remission, and reduce or stop the use of corticosteroids.

Please see the Full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.

Important Safety Information about ENTYVIO® (vedolizumab)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Uses of ENTYVIO® (vedolizumab)

ENTYVIO is a prescription medicine used in adults:

Please see the Full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.