What You Need to Know About Entyvio (Vedolizumab)

This IBD drug prevents inflammation in the digestive tract

Entyvio (vedolizumab) is a gut-homing α4β7 integrin antagonist that works to treat the two main forms of inflammatory bowel disease (IBD). Entyvio works by binding to the α4β7 integrin, which stops the integrin from further contributing to the inflammation in the digestive system that is associated with IBD. Entyvio is currently approved to treat moderate to severe Crohn's disease or moderate to severe ulcerative colitis. Entyvio was developed by, and is marketed by, Takeda Pharmaceuticals.

The Most Important Things to Know

  • People who have an infection should not receive Entyvio.
  • A tuberculosis (TB) test should be given before starting Entyvio.
  • Vaccinations should be up-to-date before starting, and no live vaccinations should be given, during treatment with Entyvio.
  • Entyvio is given intravenously, with three starting doses, and every eight weeks thereafter.
  • It is not known how Entyvio will affect a growing fetus or a breastfeeding infant.

How It's Taken

Entyvio is given by infusion, either at a doctor's office, hospital, or infusion center. When treatment first begins, Entyvio is given in three starting infusions: the first infusion, followed by another infusion two weeks later, and a third four weeks after that (the total elapsed time is six weeks). After that third infusion, Entyvio is then given about every eight weeks.

Each infusion takes about half an hour. The physician prescribing Entyvio will give any special instructions to follow before and after infusions.


Entyvio is available to treat patients with moderate to severe cases of both of the major forms of IBD (Crohn's disease and ulcerative colitis). Entyvio is not approved to treat children under the age of 18. If treatment is effective, people taking Entyvio may find their signs and symptoms of IBD abate, and they could achieve a period of remission.

Crohn's Disease

The 2018 guidelines for the treatment of Crohn's disease stated that Entyvio should be used when the disease is resistant to corticosteroids and/or not improving with thiopurines or methotrexate (immunomodulators). However, 2020 guidelines state that for people with moderate to severe disease, Entyvio should be considered as an initial therapy for the induction of remission in people who have significant symptoms.

The combination of a biologic (such as Entyvio) and an immunomodulator appears to be more effective than either of these types of drugs used alone.

Ulcerative Colitis

Similar to the case with Crohn's disease, Entyvio was once recommended only after other medications had stopped working or failed to work. This changed with the 2020 guidelines, and now a biologic medication (such as Entyvio) is recommended as the first choice for treatment after diagnosis for adults who have moderate to severe ulcerative colitis. Biologic medications are more likely to induce remission (and reduce potential complications) than previous first line options.

Drugs for ulcerative colitis that are considered biologics or small molecules include Entyvio, Remicade (infliximab), Humira (adalimumab), Simponi (golimumab), Stelara (ustekinumab), and Xeljanz (tofacitinib).

For those who have not received a biologic medication before, Entyvio or Remicade are the preferred medications. (In contrast, for those who have been on a Remicade, Stelara or Xeljanz are recommended over Entyvio.)

Once remission has been achieved with Entyvio, the medication should be continued as maintenance therapy (not stopped).

As with Crohn's disease, the combination of a biologic and an immunomodulator appears to be more effective than either of these categories alone.

Who Should Not Take Entyvio

Tell your doctor if you have ever had any of the following conditions:

  • Allergic reactions to any medication
  • Are breastfeeding
  • Are currently pregnant or trying to become pregnant
  • Liver disease
  • Infections
  • Recent vaccination
  • Tuberculosis (TB)

Side Effects

According to the prescribing information from Takeda Pharmaceuticals, the most common side effects of Entyvio include:

  • The common cold
  • Headache
  • Joint pain
  • Nausea
  • Fever
  • Upper respiratory tract infection
  • Fatigue
  • Cough
  • Bronchitis
  • Influenza
  • Back pain
  • Rash, itching
  • Sinus infection
  • Throat pain
  • Pain in extremities

Tell your doctor if any side effects are bothersome or don't go away.

Rarely other, more serious side effects can occur, such as allergic reactions that could lead to anaphylaxis. An increased risk of infection is also a concern, and infections have been reported in patients who received Entyvio.

Side effects, especially any that could indicate an allergic reaction or an infection, should be reported to the prescribing physician right away.


Entyvio has not yet been extensively studied for drug interactions. Tell your doctor if you are taking Tysabri (natalizumab), a tumor necrosis factor alpha blocker, immunosuppresants, or corticosteroids. Always tell your doctor about all medications and supplements you are taking.

There are no known food interactions.

Safety During Pregnancy

The FDA has classified Entyvio as a type B drug. The effect that Entyvio has on an unborn child has not been studied extensively. Entyvio should only be used during pregnancy if clearly needed. Notify the prescribing doctor if you become pregnant while taking Entyvio. It is not known if Entyvio passes into breast milk. The potential for serious side effects in an infant should be weighed against the usefulness of the medication to the mother. Another option is to discontinue breastfeeding before administering Entyvio.

How Long Entyvio Can Be Taken Safely

Entyvio was approved in 2014, and therefore not much is known yet about its long-term use. A review of six trials of Entyvio that took place over a period of four years showed that the drug has a favorable safety profile.

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Article Sources
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  1. Colombel JF, Sands BE, Rutgeerts P, et al. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017;66(5):839-851. doi:10.1136/gutjnl-2015-311079

  2. U.S. Food and Drug Administration. Highlights of prescribing information. Updated May 2014.

  3. Entyvio vedolizumab. Administration.

  4. Lichtenstein GR, Loftus EV, Isaacs KL, Regueiro MD, Gerson LB, Sands BE. ACG clinical guideline: management of Crohn's disease in adultsAm J Gastroenterol. 2018;113(4):481-517. doi:10.1038/ajg.2018.27

  5. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020;158(5):1450-1461. doi:10.1053/j.gastro.2020.01.006

Additional Reading
  • CCFA.org. Biologic Therapies. Crohn's And Colitis Foundation Of America. 6 Feb 2014.

  • Entyvio.com. About Entyvio. Takeda Pharmaceuticals, Inc. 2015.

  • EntyvioHCP.com. Mechanism of Action. Takeda Pharmaceuticals, Inc. 2015.

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