How ENTYVIO Works

ENTYVIO is a prescription medicine used in adults with moderately to severely active ulcerative colitis or Crohn's disease when certain other medications have not worked well enough or cannot be tolerated.

ENTYVIO may help begin to reduce some of your symptoms, achieve remission, and reduce or stop the use of steroids.

Please listen for Important Safety Information in this video.

ENTYVIO is a prescription medicine for adults with moderately to severely active ulcerative colitis or Crohn's disease.

As part of your body's natural immune response, certain white blood cells are programmed to go to different tissues and play a role in defending against disease.

Some of these white blood cells are directed to enter the gastrointestinal tract, also known as the GI tract.

In people with ulcerative colitis or Crohn's disease, the increased number of these white blood cells causes inflammation and certain symptoms.

This is a microscopic view of your GI tract.

Just like other areas of your body, it contains blood vessels that carry all sorts of important items through your body, like oxygen, vital nutrients and white blood cells. Some of these white blood cells are directed to go to the gut, like these blue spheres right here. In ulcerative colitis and Crohn's disease, inflammation is caused in part by the movement of these gut-directed white blood cells from the blood vessels out into the GI tissue.

This release is made possible in part by the interaction of two key proteins: α4β7 and MAdCAM-1.

Let's take a closer look at this interaction. MAdCAM-1, or this yellow structure dangling here, is a protein that is mainly found in GI blood vessels. It's waiting for a partner to link up with—the protein α4β7. Yep, these green prongs right here. α4β7 is found on those white blood cells we saw earlier.

So why is all this important? Think of α4β7 as the key, and MAdCAM-1 as the lock.

An important step in the movement of these white blood cells from the blood vessel into the GI tissues is the linking of these two proteins.

So one way to reduce GI inflammation, which, remember, is caused by the accumulation of an excess amount of white blood cells here, a place to start would be to block this interaction.

So this helps explain how ENTYVIO works. ENTYVIO specifically binds to the α4β7 protein, blocking its interaction with MAdCAM-1.

In this way, ENTYVIO works to block the movement of these gut-directed white blood cells into the inflamed GI tissue. Unable to match their α4β7 keys with MAdCAM-1 locks, they continue moving through the blood vessel, which helps to control inflammation and symptoms of ulcerative colitis and Crohn's disease.

Uses of ENTYVIO^® (vedolizumab)
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

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-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).
• 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.
• 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, 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.

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

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.