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What is the most important information I should know about DOVATO?

moderately to severely active Crohn’s diseaseDOVATO is a complete prescription regimen to treat HIV-1 in adults who have not received HIV-1 medicines in the past or to replace their current HIV-1 medicines when their doctor determines they meet certain requirements.moderately to severely active ulcerative colitis.Visit or call 1-80.ĮNTYVIO is a prescription medicine used in adults for the treatment of: You are encouraged to report negative side effects of prescription drugs to the FDA.

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Please see the full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.

Before receiving 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, breastfeeding, plan to become pregnant, or plan to breastfeed.

Call your healthcare provider for medical advice about side effects. These are not all the possible side effects of ENTYVIO.

The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities.

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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 the skin and eyes (jaundice). Liver problems can happen in people who receive ENTYVIO.Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision. There is no known treatment, prevention, or cure for PML. PML can result in death or severe disability. Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus).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, red or painful skin or sores on your body, tiredness, or pain during urination. ENTYVIO may increase your risk of getting a serious infection.

Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing). You may need treatment if you have an allergic reaction. Infusion-related and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment.Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.ĮNTYVIO may cause serious side effects, including:.