What You Need to Know About Entyvio (Vedolizumab)

This IBD drug prevents inflammation in the digestive tract

Table of Contents
View All
Table of Contents

Entyvio (vedolizumab) is a gut-homing α4β7 integrin antagonist approved to treat moderate to severe Crohn's disease or moderate to severe ulcerative colitis—the two main forms of inflammatory bowel disease (IBD).

Given via infusion, Entyvio works by binding to the α4β7 integrin, which stops it from further contributing to the inflammation in the digestive system that is associated with IBD.

Key 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.
  • It is not known how Entyvio will affect a growing fetus or a breastfeeding infant.


Entyvio is available to treat patients age 18 and over with moderate to severe cases of both of the major forms of IBD (Crohn's disease and ulcerative colitis).

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

Treatment guidelines released in 2020 by the American Gastroenterological Association (AGA) 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.

This differs from previous guidance that Entyvio should only be used when the disease is resistant to corticosteroids and/or not improving with thiopurines or methotrexate (immunomodulators).

Ulcerative Colitis

Similarly, Entyvio was once recommended for ulcerative colitis 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, as well as 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).

For both Crohn's and ulcerative colitis, the combination of a biologic like Entyvio and an immunomodulator appears to be more effective than either of these types of drugs alone.


Tell your doctor if any of the following apply (or have ever applied) to you, as Entyvio may not be the right drug for you:

  • Allergic reactions to any medication
  • Liver disease
  • Infections
  • Recent vaccination
  • Tuberculosis (TB)

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 It's Taken

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

Each infusion takes about half an hour and will take place at either a doctor's office, hospital, or infusion center.

The physician prescribing Entyvio will give any special instructions to follow before and after infusions.

Side Effects

According to the prescribing information from the drug's developer, 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.

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

How Long Entyvio Can Be Taken Safely?

Entyvio was approved in 2014. Therefore, not much is known 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.


Entyvio has not yet been extensively studied for drug interactions. Tell your doctor if you are taking:

Always tell your doctor about all medications and supplements you are taking.

There are no known food interactions.

Was this page helpful?
Article Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  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. 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

  4. 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

  5. Entyvio vedolizumab. Administration.

Additional Reading