The use of Entyvio (generic name: vedolizumab) is not recommended in patients with an active, severe infection until the infection is controlled. Your doctor may consider withholding your Entyvio treatment if you develop a severe infection while on treatment with Entyvio. Your doctor will be able to best decide if you need to take an antibiotic or stop Entyvio treatment. Do not stop taking Entyvio without speaking to your doctor.

What does Entyvio treat?

Entyvio (vedolizumab) from Takeda Pharmaceuticals is approved to treat adult patients with moderate to severe ulcerative colitis or Crohn‘s disease. Entyvio is a biologic drug and classified as an integrin receptor antagonist. It blocks circulating inflammatory white blood cells in the gut to decrease inflammation. Entyvio works differently than some other biologics, as it targets the gut specifically instead of the entire body.

Entyvio is given by a health care provider through a needle placed in a vein (IV) in your arm. Entyvio infusions take about 30 minutes each time.

Will Entyvio cause an infection?

Entyvio may increase your risk of getting a serious infection. Before receiving Entyvio and during treatment with Entyvio, tell your health care 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
• pain during urination.

Also let them know if you have infections that keep coming back.

The most commonly reported infections in clinical trials included the common cold or an upper respiratory tract infection.

Table 1. Incidence of common infections with Entyvio

Tell your doctor If you have a history of infections that keep coming back or severe infections. Your doctor may screen you for tuberculosis (TB) before starting treatment.

Serious infections have also been reported in patients treated with Entyvio, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis and cytomegaloviral colitis.

Before you start treatment with Entyvio, you should be brought up to date with all your needed vaccines. Once you start treatment, you may only receive live vaccines if the benefit outweighs the risk. Ask your doctor about vaccines before you start Entyvio.

Also, be sure to tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal or dietary supplements.

Can other drugs increase the risk of infection with Entyvio?

Yes. Especially tell your health care provider if you take or have recently taken:

• Tysabri (natalizumab), a Tumor Necrosis Factor (TNF) blocker medicine.
• A medicine that weakens your immune system (immunosuppressant).
• A corticosteroid medicine, for example: prednisone or methylprednisolone.
• Natalizumab (Tysabri), a drug that might increase your risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML).

Bottom Line

• The use of Entyvio is not recommended in patients with an active, severe infection until the infection is controlled.
• Your doctor can assess your infection and determine if you need antibiotics and if you should stop treatment with Entyvio.
• Entyvio may increase your risk of getting a serious infection. Tell your doctor if you have signs or symptoms of an infection, such as a fever, chills, muscle aches, cough, or other symptoms.