Vedolizumab ENTYVIO®

WHAT ARE THE MOST LIKELY SIDE EFFECTS?

Like all drugs, vedolizumab can have side effects, although not everyone experiences these. Some side effects can happen almost immediately, in direct response to the infusion. Others may not appear for several days, weeks or even longer. It can take up to 6 months after the last dose for vedolizumab to be completely eliminated from the body, so some effects might appear during this time.

Some side effects are mild and will go away on their own, or following a slight change to the infusion programme. Others may be more serious and will require treatment.

Side effects of vedolizumab may include the following:

• Infusion and serious allergic reactions. These reactions can happen while you are 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 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)
• Infections. ENTYVIO may increase your risk of getting a serious infection. Before receiving ENTYVIO and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or have 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
• Progressive Multifocal Leukoencephalopathy (PML). Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML. PML can result in death or severe 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 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.
• Liver Problems. Liver problems can happen in people who receive 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 stomach (abdomen), dark urine, or yellowing of the skin and eyes (jaundice).

As mentioned above, your doctor should talk through the risks and benefits before you start on vedolizumab. Let your doctor or IBD nurse know about any new symptoms you develop while on vedolizumab, whenever they occur. Your IBD team should also be able to help with any queries and concerns.

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