ENTYVIO (VEDOLIZUMAB) 300MG INJECTION

 Entyvio side effects

Entyvio can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Entyvio. This list does not include all possible side effects.

For more information on the possible side effects of Entyvio, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Entyvio include:

• runny nose
• sore throat
• respiratory infection such as bronchitis or sinus infection
• headache
• joint pain
• nausea
• fever
• fatigue
• cough
• flu
• back pain
• rash or itchy skin

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

Allergic reaction and infusion reaction. Some people have allergic reactions or infusion reactions when Entyvio is given. These are usually not severe, but may be severe in some cases. Administration of Entyvio will need to be stopped if a severe reaction occurs. These reactions can happen after the first dose of Entyvio or later doses. Symptoms may include:

• trouble breathing
• itchy skin
• flushing
• rash
• hives
• fast heart rate
• increased blood pressure

Liver damage. Some people who receive Entyvio can experience liver damage. If you develop liver damage symptoms, your doctor may stop your treatment with Entyvio. Symptoms of liver damage can include:

yellowing of your skin or the whites of your eyes

• fatigue
• stomach pain

Cancer. During studies of Entyvio, about 0.4 percent of those who received Entyvio developed cancer compared to about 0.3 percent who received a placebo. Whether Entyvio increases the risk of cancer isn’t clear.

Infections. People who take Entyvio have an increased risk of infection, such as the common cold or flu. More serious infections may also occur. These might include tuberculosis or an infection in the brain called progressive multifocal leukoencephalopathy (see below). If you develop a severe infection while taking Entyvio, you may need to stop taking the medication until the infection has been treated.

ENTYVIO (VEDOLIZUMAB) 300MG INJECTION

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

PML

Progressive multifocal leukoencephalopathy (PML) is a serious viral infection of the brain. It typically only happens in people whose immune system isn’t fully functioning.

During studies, PML did not occur in anyone who took Entyvio. However, it has occurred in people receiving medications that are similar to Entyvio, such as Tysabri (natalizumab).

While you take Entyvio, your doctor will monitor you for symptoms of PML. These symptoms may include:

• weakness on one side of your body
• vision problems
• clumsiness
• memory problems
• confusion

If you have questions or concerns about this potential side effect, talk with your doctor or pharmacist.

Hair loss

Hair loss isn’t a side effect that has occurred in studies of Entyvio. However, some people have had hair loss while taking Entyvio. It’s not clear if Entyvio is the cause of hair loss. If you have questions or concerns about this potential side effect, talk with your doctor or pharmacist.

Weight gain

Weight gain isn’t a side effect that has occurred in studies of Entyvio. However, some people who take Entyvio say that they gain weight. Gaining weight may be the result of healing in the gut, especially for those who’ve lost weight due to a flare-up of symptoms of the condition being treated. If you have questions or concerns about weight gain during your treatment, talk with your doctor or pharmacist.