Administration Information

Intravenous infusion and self-administered injection under the skin (subcutaneous)

Here's how ENTYVIO works

ENTYVIO is designed to fit your lifestyle, with two ways to administer maintenance therapy: intravenous (IV) infusion or self-administered injection. However, everyone who starts ENTYVIO will have at least two (2) IV starter doses. You and your doctor will discuss whether to continue treatment by IV or to transition to the ENTYVIO Pen for your following doses (known as maintenance doses).

​One ENTYVIO. Two administration options.

Option 1:
IV infusion

• ENTYVIO IV treatment is administered in an office, infusion center, or at home with medical support
• A healthcare professional administers ENTYVIO by IV infusion and stays to monitor your treatment
• The ENTYVIO IV is delivered in the arm and takes about 30 minutes
• After your starting doses, the infusion is given every 8 weeks

Option 2:
ENTYVIO Pen

• The ENTYVIO Pen offers flexibility in your treatment at home or on the go
• A specialty pharmacy will reach out to you regarding coordination and delivery of the ENTYVIO Pen
• The ENTYVIO Pen can be administered in 3 different areas on the body
• After your starting doses, you deliver your treatment every 2 weeks

Talk to your doctor about which option would be the best fit for you.

What are the differences between your options?

Option 1: IV infusion

Regardless of which maintenance dosing option you and your healthcare provider end up choosing, you’ll receive at least 2 starter doses of ENTYVIO by 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 last approximately 30 minutes. During and after the infusion, your healthcare provider will monitor you for side effects to see if you have a reaction to the treatment.

Starting treatment schedule

You will receive ENTYVIO by infusion at Weeks 0, 2, and 6.

Maintenance schedule

After your initial doses, you will continue to receive ENTYVIO by IV every 8 weeks.

• In the first year, you'll receive 8 doses of ENTYVIO
• After the first year, you'll receive 6 doses each year

Total number of doses during the first year

In the first year, you’ll receive 8 doses of ENTYVIO, each infused over 30 minutes, for a total infusion time of approximately 4 hours.

Option 2: Self-administered injection (subcutaneous)

The ENTYVIO Pen supports your therapy at home or on the go.* With the ENTYVIO Pen, ENTYVIO is delivered through an under-the skin (subcutaneous) injection, which can be self-administered in several different areas on the body. Check out the Instructions for Use below for more details, or talk to your healthcare provider—who will also train you on how to use your single-dose, prefilled pen. Before you start using the ENTYVIO Pen, you’ll receive your first two doses of ENTYVIO by IV infusion.

*The prefilled pen can be left out in the original package at room temperature up to 77°F for a total of 7 days. Do not use the prefilled pen if it is left out of the refrigerator for more than 7 days.

How often do you inject ENTYVIO?

After your initial two IV starter doses, you'll inject ENTYVIO every 2 weeks.

Starting treatment schedule

You will receive ENTYVIO by IV infusion at Weeks 0 and 2.

Maintenance schedule

You'll inject ENTYVIO at Week 6 and then every two weeks after that, up to 26 times per year.

Your healthcare provider will determine if it's appropriate to transition to self-administration with ENTYVIO Pen after at least 2 IV doses.

How do you inject the ENTYVIO Pen?

Ask your healthcare provider for more information about injecting the ENTYVIO Pen. For step-by-step instructions, download the Instructions for Use below.

Get the support you’re looking for

EntyvioConnect is here to support you with resources and information.

Community of support

Learn about resources that can help connect you to other people living with UC or Crohn’s.

Have you been prescribed ENTYVIO?

Visit the Treatment Site for resources designed for people currently on ENTYVIO.

IMPORTANT SAFETY INFORMATION

• 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-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).

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

  ENTYVIO is available for:

  • intravenous (IV) infusion: 300 mg vedolizumab.
  • subcutaneous (SC) injection: 108 mg 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 1-800-FDA-1088.

  What is ENTYVIO (vedolizumab)?

  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.

  Want to learn more about ENTYVIO and how it works?

  Enter your email below for more information!

  Please enter a valid email address

  Important Safety Information

  • 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-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).

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

    ENTYVIO is available for:

    • intravenous (IV) infusion: 300 mg vedolizumab.
    • subcutaneous (SC) injection: 108 mg 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 1-800-FDA-1088.

    What is ENTYVIO (vedolizumab)?

    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.

    This site is intended for use by U.S. residents only.

    ©2024 Takeda Pharmaceuticals U.S.A., Inc. 500 Kendall Street, Cambridge, MA 02142. 1-877-TAKEDA-7 (1-877-825-3327) . All rights reserved. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited. ENTYVIO and the ENTYVIO logo are registered trademarks of Millennium Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

    You are About to Leave this Website and Enter a Website Operated by an Independent Third Party

    The links to third-party websites contained on this website are provided solely for your convenience. Takeda does not control the content contained on any third-party website linked from this website. Your activities at those websites will be governed by the policies and practices of those third parties.

    Please select "Continue" if you wish to be taken to this third-party website.