For adult patients with moderately to severely active UC or CD when other therapies have not worked well enough.

INDICATIONS: Entyvio (vedolizumab) is indicated for adult patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) who have had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids, or who have had an inadequate response with, lost response to, or were intolerant to an immunomodulator or a tumor necrosis factor (TNF) blocker.1

In UC, Entyvio is indicated for inducing and maintaining clinical response and clinical remission, improving the endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.

In CD, Entyvio is indicated for achieving clinical response, clinical remission, and corticosteroid-free remission.

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For adult patients with moderately to severely active UC or CD when other therapies have not worked well enough.

INDICATIONS: Entyvio (vedolizumab) is indicated for adult patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) who have had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids, or who have had an inadequate response with, lost response to, or were intolerant to an immunomodulator or a tumor necrosis factor (TNF) blocker.1

In UC, Entyvio is indicated for inducing and maintaining clinical response and clinical remission, improving the endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.

In CD, Entyvio is indicated for achieving clinical response, clinical remission, and corticosteroid-free remission.

Below you will find a wide array of resources related to UC, CD, and Entyvio.

Request a Representative

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EntyvioConnect

Access and Coverage

Enroll your patients in EntyvioConnect for benefits investigations, co-pay support, and related offerings.

Selected AGA Care Pathway for ulcerative colitis

Selected AGA Care Pathway for UC

View a pathway for UC, which includes Entyvio as one of the first-line biologic options after conventional therapy failure.

Full Prescribing Information

Full Prescribing Information

Download the Full Prescribing Information for Entyvio.

Clinical Reprints

Clinical Reprints

Download select publications
that describe the efficacy and
safety of Entyvio.

Peer Perspectives

Peer Perspectives

Leading gastroenterologists review the clinical profile of Entyvio and discuss how they use it to treat appropriate patients in their practices. Featured experts include Dr. Stephen Hanauer, Dr. Brian Feagan, and Dr. Remo Panaccione.

Important Safety Information

  • ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
  • Infusion-related reactions and hypersensitivity reactions including anaphylaxis have occurred. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
  • Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
  • Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
  • Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.
  • Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Indications

Adult Ulcerative Colitis (UC)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.

Adult Crohn’s Disease (CD)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid-free remission.

Please see full Prescribing Information, including Medication Guide.

  1. Entyvio [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.
  2. Data on file. Takeda Pharmaceuticals America, Inc. Deerfield, IL.
  3. Feagan BG, Rutgeerts P, Sands BE, et al; for the GEMINI 1 Study Group. N Engl J Med. 2013;369(8):699-710.
  4. Sandborn WJ, Feagan BG, Rutgeerts P, et al; for GEMINI 2 Study Group. N Engl J Med. 2013;369(8):711-721.
  5. Colombel JF, Sands BE, Rutgeerts P, et al. Gut. 2016. doi:10.1136/gutjnl-2015-311079.
  6. Feagan BG, Rubin DT, Danese S, et al. Clin Gastroenterol Hepatol. 2017;15(2):229-239.e5.
  7. Sands BE, Feagan BG, Rutgeerts P, et al. Gastroenterology. 2014;147(3):618-627.e3.
  8. Xavier RJ, Podolsky DK. Nature. 2007;448(7152):427-434.
  9. Briskin M, Winsor-Hines D, Shyjan A, et al. Am J Pathol. 1997;151(1):97-110.

Important Safety Information

  • ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
  • Infusion-related reactions and hypersensitivity reactions including anaphylaxis have occurred. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
  • Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
  • Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
  • Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.
  • Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Indications

Adult Ulcerative Colitis (UC)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.

Adult Crohn’s Disease (CD)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid-free remission.

Please see full Prescribing Information, including Medication Guide.

  1. Entyvio [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.
  2. Data on file. Takeda Pharmaceuticals America, Inc. Deerfield, IL.
  3. Feagan BG, Rutgeerts P, Sands BE, et al; for the GEMINI 1 Study Group. N Engl J Med. 2013;369(8):699-710.
  4. Sandborn WJ, Feagan BG, Rutgeerts P, et al; for GEMINI 2 Study Group. N Engl J Med. 2013;369(8):711-721.
  5. Colombel JF, Sands BE, Rutgeerts P, et al. Gut. 2016. doi:10.1136/gutjnl-2015-311079.
  6. Feagan BG, Rubin DT, Danese S, et al. Clin Gastroenterol Hepatol. 2017;15(2):229-239.e5.
  7. Sands BE, Feagan BG, Rutgeerts P, et al. Gastroenterology. 2014;147(3):618-627.e3.
  8. Xavier RJ, Podolsky DK. Nature. 2007;448(7152):427-434.
  9. Briskin M, Winsor-Hines D, Shyjan A, et al. Am J Pathol. 1997;151(1):97-110.