Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Entyvio (Vedolizumab).

Allergic reactions: In rare cases, some people may develop a severe allergic reaction to Entyvio (Vedolizumab). These reactions may not occur with the first infusion of the medication, and may happen with future doses of Entyvio (Vedolizumab). Your health care provider will monitor you while you are receiving Entyvio (Vedolizumab) by infusion. Signs of an allergic reaction include a severe rash, Hives, swollen face or throat, difficulty breathing, lightheadedness, or dizziness. If any of these occur, contact your doctor immediately.

Infections: Entyvio (Vedolizumab) may increase the risk of developing an infection, including serious infections such as sepsis, pneumonia, and tuberculosis. Before starting Entyvio (Vedolizumab) treatment, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, coughing, or pus, contact your doctor as soon as possible. Entyvio (Vedolizumab) should also not be started while you have an active infection.

Liver function: Entyvio (Vedolizumab) can cause decreased liver function. If you have liver problems, discuss with your doctor how Entyvio (Vedolizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entyvio (Vedolizumab), and whether any special monitoring is needed. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): Although there have not been reports of PML after using Entyvio (Vedolizumab), it has been reported with other medications in the same family. PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.

Vaccines: Live vaccines (e.g., BCG, yellow fever) are not recommended for people taking Entyvio (Vedolizumab). Talk to your doctor if you need any vaccinations while taking Entyvio (Vedolizumab).

Pregnancy: Entyvio (Vedolizumab) should not be used during pregnancy. If you are of childbearing age, effective birth control should be used while you are being treated with Entyvio (Vedolizumab) and for at least 18 weeks after your final treatment. If you become pregnant while taking Entyvio (Vedolizumab), contact your doctor immediately.

Breast-feeding: Entyvio (Vedolizumab) passes into breast milk. If you are a breast-feeding mother and are taking Entyvio (Vedolizumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Entyvio (Vedolizumab) have not been established for children.