Entyvio for Ulcerative Colitis

ENTYVIO made remission real for many people with moderate to severe ulcerative colitis (UC)

Patient Portrayal

In two clinical trials, ENTYVIO delivered results for adults with moderate to severe ulcerative colitis when other medicines had not worked well enough or could not be tolerated.

The first study evaluated response to ENTYVIO versus placebo at Week 6. The second study included adults who had a previous response to ENTYVIO at Week 6 and evaluated remission at Week 52.

Results with IV infusion were seen as early as 6 weeks

ENTYVIO helped

NEARLY TWICE

as many people achieve response
vs placebo

At 6 weeks of treatment, 47% of people on ENTYVIO infused intravenously achieved response* compared to 26% of people on placebo.

Long-term remission with IV infusion

ENTYVIO helped

MORE THAN TWICE

as many people achieve
remission at 1 year
vs placebo

42% of people on ENTYVIO infused intravenously achieved remission^† at 1 year of treatment, compared to 16% of people on placebo.

*Response is a measure to determine improvement of the patient's UC symptoms and condition.

^†Remission is a measure to determine when a patient with UC is experiencing few to no symptoms and an improvement in their condition.

In the ENTYVIO clinical studies, clinical response and remission was defined and measured by improvement in the Mayo score, an assessment tool that measures stool frequency, rectal bleeding, appearance of the mucosal lining of the colon, and physician assessment.

Results your doctor can see

ENTYVIO helped many people improve their intestinal lining.

For many people, ENTYVIO infused intravenously improved how their intestinal lining looked to their doctor.

As early as Week 6, 41% of patients experienced improvement compared to 25% of people on placebo
At 1 year, 52% of patients experienced improvement compared to 20% on placebo

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 (feeling like your heart is racing).

Please see additional Important Safety Information below.

Remission with the ENTYVIO Pen

THE ENTYVIO PEN

helped more people achieve
remission at 1 year
vs placebo

A separate clinical study evaluated remission at week 52 in adult patients with moderate to severe UC who were administered ENTYVIO subcutaneously vs placebo.

46% of people administered ENTYVIO subcutaneously achieved relief and remission at 1 year of treatment compared to 14% of people on placebo.

In a separate head-to-head study,

Humira is a registered trademark of AbbVie, Inc. For information related to adalimumab, please see AbbVie.com.

ENTYVIO helped

SIGNIFICANTLY MORE

adult patients with moderate to severe UC than HUMIRA achieve remission at 1 year

31% of people on ENTYVIO given as IV infusion achieved remission at 1 year compared to 23% of people on HUMIRA.

Ask your doctor if ENTYVIO is right for you.

Sign up for EntyvioConnect

Ready to access everything EntyvioConnect has to offer? Sign up today!

What’s an ENTYVIO infusion like?

Questions about infusions? Here’s how it works.

Learn more

What's it like to get an ENTYVIO infusion?

Here's what you can expect when you take ENTYVIO.

Learn more

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).
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 extremities, and with injections under the skin: pain, swelling, itching, hives, bruising, rash, or redness at the injection site. 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.
Tell your healthcare provider about all the medicines you take, especially 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.

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-10881-800-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.

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).

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

Tell your healthcare provider about all the medicines you take, especially 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.

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-10881-800-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.

Entyvio for Ulcerative Colitis

ENTYVIO made remission real for many people with moderate to severe ulcerative colitis (UC)

Results with IV infusion were seen as early as 6 weeks

Long-term remission with IV infusion

Results your doctor can see

IMPORTANT SAFETY INFORMATION

Remission with the ENTYVIO Pen

In a separate head-to-head study,

Ask your doctor if ENTYVIO is right for you.

Sign up for EntyvioConnect

What’s an ENTYVIO infusion like?

What's it like to get an ENTYVIO infusion?

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

You are about to leave this website.

Share with Your Friends and Family: