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Vedolizumab

Brand names: Entyvio

What is vedolizumab used for?

  • Vedolizumab is used to treat Crohn's disease.
  • It is used to treat ulcerative colitis.
  • Vedolizumab may be given to you for other reasons. Talk to your doctor.

Before taking vedolizumab, tell your doctor:

  • If you are allergic to vedolizumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have an infection.
  • If you are taking any of these drugs: Adalimumab, certolizumab, etanercept, golimumab, infliximab, or natalizumab.

This is not a list of all drugs or health problems that interact with vedolizumab.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take vedolizumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take vedolizumab?

  • Tell all of your health care providers that you take vedolizumab. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
  • You may need a TB (tuberculosis) test before starting vedolizumab.
  • Make sure you are up to date with all your vaccines before treatment with vedolizumab.
  • Talk with your doctor before getting any vaccines. Use of some vaccines with vedolizumab may either raise the chance of an infection or make the vaccine not work as well.
  • Some patients have severe side effects from the infusion. This could happen during the infusion or within many hours after the infusion is over. Tell your doctor if you have any bad effects during or after the infusion.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
  • If you used vedolizumab when you were pregnant, tell your baby's doctor.

How is vedolizumab best taken?

Use vedolizumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are the side effects of vedolizumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath.
  • Dizziness.
  • Flushing.
  • Fast or abnormal heartbeat.
  • A very bad brain problem called progressive multifocal leukoencephalopathy (PML) may happen with vedolizumab. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

What are some other side effects of vedolizumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Back pain.
  • Signs of a common cold.
  • Headache.
  • Joint pain.
  • Upset stomach.
  • Nose or throat irritation.
  • Pain in arms or legs.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out vedolizumab?

  • If you need to store vedolizumab at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer information use and disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time vedolizumab is refilled. If you have any questions about vedolizumab, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take vedolizumab or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 vedolizumab. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated June 19, 2020.