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Entyvio

Generic Name: vedolizumab (VE-doe-LIZ-ue-mab)
Brand Name: Entyvio

Entyvio is used for:

Entyvio is used to treat moderate to severe Crohn disease or ulcerative colitis in certain patients. It may also be used for other conditions as determined by your doctor.

Entyvio is a monoclonal antibody. It works by blocking the action of a substance in the body and reducing the inflammation associated with Crohn disease and ulcerative colitis.

Do NOT use Entyvio if:

  • you are allergic to any ingredient in Entyvio
  • you have an active, severe infection
  • you are using adalimumab, certolizumab, etanercept, golimumab, infliximab, or natalizumab

Contact your doctor or health care provider right away if any of these apply to you.

Before using Entyvio:

Some medical conditions may interact with Entyvio. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have any type of infection, including bacterial or viral infection, fungal infection (eg, coccidiomycosis, histoplasmosis), tuberculosis (TB) infection, skin infection, or open cuts or sores on your body
  • if you have a history of long-term or recurrent infections, TB or a positive TB skin test, or if you have recently been around someone who has had TB
  • if you have conditions that may increase your risk of infection (eg, diabetes) or if you have traveled to or lived in an area where TB or other certain infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common
  • if you have immune system problems or liver problems

Some MEDICINES MAY INTERACT with Entyvio. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Adalimumab, certolizumab, etanercept, golimumab, infliximab, or natalizumab because the risk of infection may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Entyvio may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Entyvio:

Use Entyvio as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Entyvio comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Entyvio refilled.
  • Entyvio is given as an infusion at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • If you miss a dose of Entyvio, contact your doctor to find out what to do.

Ask your health care provider any questions you may have about how to use Entyvio.

Important safety information:

  • Before you use Entyvio, discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations.
  • Talk with your doctor before getting any vaccines.
  • Tell your doctor or dentist that you take Entyvio before you receive any medical or dental care, emergency care, or surgery.
  • Entyvio may lower the ability of your body to fight infection. Severe and sometimes fatal infections have happened with Entyvio. Avoid contact with people who have colds or infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. If you develop a fever, feel very tired, have a cough, or have flu-like symptoms, these could be signs that you may be getting an infection. If any of these symptoms occur, contact your doctor at once.
  • A serious brain problem called progressive multifocal leukoencephalopathy (PML) may happen with this drug. It may cause disability or death. Tell your doctor right away if you have signs like confusion, memory problems, depression, change in the way you act, one-sided weakness, trouble speaking or thinking, change in balance, clumsiness, or change in eyesight.
  • Some patients may have serious side effects or allergic reactions with the infusion. This could happen during the infusion or within several hours after treatment. Tell your doctor if you have rash; itching; swelling of your lips, tongue, throat, or face; shortness of breath or trouble breathing; wheezing; dizziness; feeling hot; irregular heartbeat; or any other bad effects during the infusion.
  • Lab tests may be performed while you use Entyvio. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: It is not known if Entyvio can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Entyvio while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Entyvio, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Entyvio:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; common cold; headache; joint pain; nausea; nose or throat irritation; pain in the arms or legs; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast heartbeat; flushing; severe or persistent headache; shortness of breath; symptoms of infection (eg, fever or chills, cough, muscle aches, painful or frequent urination, persistent sore throat, flu-like symptoms, persistent feeling of being unwell, unusual vaginal discharge or odor, white patches in the mouth, red or painful skin); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, right upper stomach pain, unusual tiredness, yellowing of the skin or eyes).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Entyvio:

Entyvio is handled and stored by a health care provider. You will not store it at home.

General information:

  • If you have any questions about Entyvio, please talk with your doctor, pharmacist, or other health care provider.
  • Entyvio is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Keep all medicines out of the reach of children and pets.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Entyvio or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Entyvio. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Entyvio. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Entyvio.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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