FAQs

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

• moderately to severely active ulcerative colitis (UC).
• moderately to severely active Crohn’s disease (CD).

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

Learn more about ENTYVIO here.

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.

ENTYVIO may cause serious side effects, including:

• Infusion-related 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).
• Infections. 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.
• 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 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).

Learn more about the possible side effects of ENTYVIO on the Side Effects page.

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.
• 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), Tyruko (natalizumab-sztn), a Tumor Necrosis Factor (TNF) blocker medicine, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine.

The safety of ENTYVIO was studied in 4 placebo-controlled clinical trials. It was also studied in a separate long-term extension trial for up to 7 years.

Yes, the ENTYVIO Pen is approved by the FDA for maintenance therapy to adults with moderate to severe ulcerative colitis or Crohn’s disease. Your healthcare provider can help you decide if the ENTYVIO Pen is right for you.

The ENTYVIO Pen was approved by the FDA for adults with moderate to severe ulcerative colitis in 2023. It was approved for adults with moderate to severe Crohn's disease in 2024.

ENTYVIO may cause serious side effects, learn more on the Side Effects page.

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, pain in the extremities, and with injections under the skin: pain, swelling, itching, hives, bruising, rash, or redness at the injection site.

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 offers 2 flexible administration options that support your treatment journey. You and your healthcare provider can select IV infusion or a self-administered injection with the ENTYVIO Pen.

Learn more about your administration options with ENTYVIO.

Maintenance therapy with ENTYVIO can be administered 2 different ways: intravenous (IV) infusion or a self-administered injection under the skin (subcutaneous). Regardless of which maintenance dosing option you and your healthcare provider decide on, you'll receive at least 2 starter doses of ENTYVIO by IV infusion.

IV infusion

Your healthcare provider will administer ENTYVIO through a needle placed in a vein in your arm, either at their office, at an infusion center, or in your home. Infusions typically last around 30 minutes. Your healthcare provider will monitor you both during and after your infusion for side effects to see if you have a reaction to the treatment.

Self-administered injection (subcutaneous)

Delivered subcutaneously (under the skin), the ENTYVIO Pen supports your therapy at home or on the go. It can be self-administered in 3 different areas on the body—in the stomach or thigh, or in the back of the arms (by a caregiver only). Your healthcare provider will also train you on how to use this single-dose, pre-filled pen. Learn more about the pen treatment schedule below.

Get more details about how receiving ENTYVIO works.

In clinical trials, ENTYVIO has been proven to provide adult patients with moderate to severe UC and Crohn’s remission when administered via IV infusion.

In separate clinical trials, ENTYVIO has been proven to provide adult patients with moderate to severe UC and Crohn’s remission when administered via self-administered injection. .

Everyone who starts ENTYVIO will have at least 2 IV starter doses at Weeks 0 and 2. You and your doctor will discuss whether to continue treatment by IV or to transition to self-administered injection.

The doses you receive after your starter doses, called maintenance doses, will occur either every 8 weeks with IV or every 2 weeks with the ENTYVIO Pen.

Learn more about ENTYVIO dosing and administration.

Yes, ENTYVIO can be self-injected with the ENTYVIO Pen for maintenance doses for people with moderate to severe ulcerative colitis or Crohn’s disease. That means you can take ENTYVIO at home or on the road after your initial IV starter doses.

Visit the ENTYVIO administration page for more information and talk to your healthcare provider to see if the ENTYVIO Pen could fit your lifestyle.

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), Tyruko (natalizumab-sztn), a Tumor Necrosis Factor (TNF) blocker, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine.

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

Please see additional Important Safety Information below.

Always tell your healthcare provide 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. ENTYVIO can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ENTYVIO.

For information related to COVID 19, please visit https://www.entyvio.com/COVID19 and be sure to speak with your healthcare provider.

Studies have not been done to see how ENTYVIO interacts with alcohol. Please speak with your healthcare provider.