- Do not receive entyvio if you have had an allergic reaction to entyvio or any of its ingredients.
- Entyvio can cause serious side effects, including:
- Severe allergic and infusion-related reactions can occur while receiving Entyvio or several hours after treatment. you may need treatment if you have an allergic reaction. tell your healthcare provider or get medical help right away if you have any of these symptoms during or after an entyvio infusion: rash, itching, swelling of the lips, tongue, throat, or face, shortness of breath, or difficulty breathing. shortness of breath, 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, redness or pain on the skin. or sores on the body, tiredness, or pain when urinating.
- People with weakened immune systems can get progressive multifocal leukoencephalopathy (pml) (a rare and serious brain infection caused by a virus). Although unlikely while receiving Entyvio, a risk of PML cannot be ruled out. pml can cause death or serious 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 trouble thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, poor vision blurred or loss of vision.
- Liver problems can occur in people receiving 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 your skin and eyes (jaundice).
- the most common side effects of entyvio include common cold, headache, joint pain, nausea, fever, nose and throat infections, tiredness, cough, bronchitis, flu, back pain, rash, itching , sinusitis, sore throat. and pain in the extremities. these are not all the possible side effects of entyvio. call your healthcare provider for medical advice about side effects.
- Before you receive 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, nursing, plan to become pregnant, or plan to breastfeed.
- moderately to severely active ulcerative colitis
- moderate to severe active Crohn’s disease
See full Prescribing Information, including Medication Guide, for entyvio and talk with your healthcare provider.
You are encouraged to report negative side effects of prescription medications to the FDA. visit www.fda.gov/medwatch or call 1-800-fda-1088.
uses of entyvio® (vedolizumab)
entyvio is a prescription medicine used in adults to treat: