Entyvio infusion is used in adults with ulcerative colitis (UC) or Crohn's disease that is moderate to severe. Entyvio works by preventing too many white blood cells from entering your GI tract (intestine) which helps to control inflammation and symptoms of ulcerative colitis or Crohn's disease. It works selectively in the gut to decrease inflammation and does not usually lead to system-wide immunosuppression.

Entyvio treats active disease and may help keep ulcerative colitis or Crohn's disease symptoms under control long term. Entyvio may also reduce the need for steroid medicines in helping to control symptoms long term.

Entyvio became an FDA approved medicine on May 20, 2014. Entyvio’s indications are moderate to severe ulcerative colitis (UC) or Crohn's disease in adults. No biosimilars of vedolizumab have been approved by the FDA.

Entyvio (vedolizumab) belongs to the drug class called integrin receptor antagonists. It may also be called a selective immunosuppressant or a monoclonal antibody. Entyvio’s mechanism of action, or how it works, is by binding to α4β7 integrin on the surface of a type of white blood cell called memory T-lymphocytes. Binding to α4β7 integrin blocks it from interacting with MAdCAM-1 (mucosal addressin cell adhesion molecule-1). This interaction plays a key role in causing the chronic inflammation seen in people with IBD.

Entyvio can cause serious side effects on your brain or liver, and may cause a serious infection. Call your doctor right away if you have a fever, tiredness, muscle aches, sore throat, shortness of breath, skin sores, painful urination, loss of appetite, upper stomach pain, dark urine, yellowing of your skin and eyes, or problems with speech, thought, vision, or muscle movement.

Tell your caregivers if you have any reactions during the injection, such as dizziness, nausea, itching, headache, chest tightness, trouble breathing, or swelling in your face.

Do not receive a "live" vaccine while using Entyvio.

Entyvio is given as an infusion into a vein, usually once every 2 to 8 weeks. A healthcare provider will give you this injection.

Before you start treatment with Entyvio, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

You will be watched closely for a short time after receiving Entyvio, to make sure you do not have an allergic reaction.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 14 weeks of treatment.

Usual Adult Dose for Crohn's Disease

• 300 mg IV over 30 minutes at Week 0, 2, and 6 and then every 8 weeks thereafter

Usual Adult Dose for Ulcerative Colitis:

• 300 mg IV over 30 minutes at Week 0, 2, and 6 and then every 8 weeks thereafter

Comments:

• Prior to initiating therapy, patients should be brought up to date with all immunizations according to current immunization guidelines.
• Discontinue if no evidence of therapeutic benefit by Week 14.

Uses:

• Adult Ulcerative Colitis (UC): Adults with moderately to severely active ulcerative colitis. This drug is used for inducing and maintaining clinical response or remission, improving endoscopic appearance of the mucosa, or achieving corticosteroid-free remission.
• Adult Crohn's Disease (CD): Adults with moderately to severely active Crohn's Disease. This drug is used for achieving clinical response or remission or achieving corticosteroid-free remission.

You should not use Entyvio if you are allergic to vedolizumab.

To make sure Entyvio is safe for you, tell your doctor if you have ever had:

• an active or recent infection;
• liver disease;
• signs of infection such as fever, cough, or flu symptoms;
• if you are scheduled to receive any vaccines.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

You should be up to date with all needed vaccinations before receiving Entyvio.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. Having active ulcerative colitis or Crohn's disease symptoms during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating these conditions may outweigh any risks to the baby.

If you use Entyvio while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to vedolizumab in the womb could affect your baby's vaccination schedule during the first few months of life.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vedolizumab on the baby.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Entyvio passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take this medicine. 

Call your doctor for instructions if you miss an appointment for your Entyvio injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Do not receive a "live" vaccine while using Entyvio, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

You may receive "killed-virus" vaccines such as a flu shot, polio vaccine, rabies vaccine, or hepatitis A vaccine. Ask your doctor before receiving any vaccine while you are being treated with Entyvio.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Common side effects of Entyvio

The most common side effects of Entyvio include:

• fever, sore throat, flu symptoms;
• cold symptoms such as stuffy nose, sinus pain, sneezing;
• cough with mucus, shortness of breath, chest discomfort;
• pain in your arms or legs;
• tiredness;
• headache, joint pain, back pain;
• rash, itching; or nausea.

Serious side effects of Entyvio

Get emergency medical help if you have signs of an allergic reaction to Entyvio: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Vedolizumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Call your doctor at once if you have:

• fever, chills, body aches, cold or flu symptoms, mouth and throat ulcers, skin sores;
• pain, warmth, swelling, or oozing around your anal area;
• nausea, vomiting, severe diarrhea, diarrhea that is watery or bloody, stomach cramps, weight loss;
• cough, pain when swallowing; or
• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• natalizumab;
• medicines to treat psoriasis or rheumatoid arthritis, such as etanercept or golimumab;
• other medicines to treat Crohn's disease or ulcerative colitis, such as adalimumab, certolizumab, infliximab; or
• other drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with vedolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.