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Is Entyvio an immunosuppressant or a biologic?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Sep 30, 2023.

Official answer


Entyvio (generic name: vedolizumab) is a biologic therapy approved for the treatment of ulcerative colitis and Crohn’s disease. Entyvio works by preventing too many white blood cells from entering into your GI tract (intestine). This helps to control inflammation and your symptoms of ulcerative colitis and Crohn's disease. Entyvio has no known systemic (whole body) immunosuppressive effects, but still has a risk of infections.

Entyvio is an integrin receptor antagonist and works differently than some other biologics. It specifically targets circulating inflammatory white blood cells in the gut (instead of the entire body) to help control inflammation and symptoms of ulcerative colitis and Crohn's disease.

Can Entyvio lead to infections?

Even though Entyvio is not considered a whole body immunosuppressant, it is still associated with an increased risk of infections, some that may be serious. Serious infections reported in patients treated with Entyvio included:

  • anal abscess
  • sepsis (some fatal)
  • tuberculosis
  • salmonella sepsis
  • Listeria meningitis
  • giardiasis (diarrhea caused by the parasite Giardia)
  • cytomegaloviral colitis.

Before starting treatment, 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:

  • a 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 any infections that keep coming back.

The most commonly reported infections in clinical trials included the common cold (13%) or an upper respiratory tract infection (7%). Other infections were: bronchitis (4%), influenza (4%), and sinusitis (3%).

Tell your doctor If you have a history of recurring severe infections. Your doctor may also screen you for tuberculosis (TB) before starting Entyvio treatment. You may need to have your vaccines updated, as well. You should avoid live vaccines once you start treatment with Entyvio unless your doctor approves.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Make sure you tell your health care provider if you take or have recently taken:

  • Tysabri (natalizumab) or Tyruko (natalizumab-sztn)
  • a Tumor Necrosis Factor (TNF) blocker medicine
  • a medicine that weakens your immune system (immunosuppressant)
  • or a corticosteroid medicine such as prednisone or methylprednisolone.

Taking Entyvio with other medicines known as tumor necrosis factor inhibitors can increase your risk of infections. Taking Entyvio with natalizumab might increase your risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML).

This is not all of the side effects reported with Entyvio. Discuss the side effects of Entyvio with your doctor before you start treatment.

Related questions

Bottom Line

  • Entyvio (vedolizumab) is a biologic therapy approved for the treatment of ulcerative colitis and Crohn’s disease.
  • It works selectively in the gut to decrease inflammation and does not usually lead to system-wide immunosuppression. However, infections are still a risk with Entyvio. Tell your healthcare provider if you feel like you have an infection before you start therapy and during treatment, or if you have past history of severe infections.
  • Respiratory tract infections like the common cold are the most common infection.
  • Be sure to tell your doctor about all the medications you take before you start Entyvio.

This is not all the information you need to know about Entyvio for safe and effective use. Review the full Entyvio information and discuss this information with your doctor or other health care provider.


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