Entyvio

Generic name: Vedolizumab
Dosage form: intravenous infusion, subcutaneous injection
Drug class: Selective immunosuppressants

Usage of Entyvio

Entyvio (vedolizumab) is used for ulcerative colitis (UC) or Crohn's disease to help improve symptoms, induce remission, and may also reduce the need for steroid medicines to control symptoms long-term. Entyvio is a selective immunosuppressant that works to control inflammation and symptoms of ulcerative colitis or Crohn's disease by preventing too many white blood cells from entering your GI tract (intestine). Entyvio works selectively in the gut to decrease inflammation and does not usually lead to system-wide immunosuppression.

Entyvio infusion is used for ulcerative colitis or Crohn’s disease. Entyvio Pen or prefilled syringe is used for the maintenance treatment of UC and is given as an injection under the skin (suBCutaneous injection).

Entyvio infusion became an FDA-approved medicine on May 20, 2014. its indications are moderate to severe ulcerative colitis (UC) or Crohn's disease in adults. Entyvio Pen (subcutaneous) became FDA approved on September 27,2023. No biosimilars of vedolizumab have been approved by the FDA.

Entyvio side effects

Common Entyvio side effects

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 Entyvio side effects

Get emergency medical help if you have signs of an allergic reaction to Entyvio: hives, difficulty 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 the FDA at 1-800-FDA-1088.

Before taking Entyvio

You should not use this medicine if you are allergic to the active ingredient vedolizumab or any of the inactive ingredients.

To make sure this medicine 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 this medicine.

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 infusion or pen 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.

Relate drugs

How to use Entyvio

Usual Adult IV Entyvio Infusion Dose for Crohn's Disease or for Ulcerative Colitis:

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

Usual Adult SC Entyvio Dose for Ulcerative Colitis:

For Ulcerative Colitis, following the first two Entyvio intravenous doses administered at Week 0 and Week 2, the dose may be switched to subcutaneous injection at Week 6.

Week 6 and thereafter: Administer 108 mg subcutaneously once every 2 weeks.

Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14.

Entyvio may be switched from intravenous infusion to subcutaneous injection, for patients in clinical response or remission beyond Week 6. To switch patients to subcutaneous injection, administer the first subcutaneous dose in place of the next scheduled intravenous infusion and every two 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.

Warnings

Entyvio infusion and pen 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 this medicine.

What other drugs will affect Entyvio

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.

Disclaimer

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