For adults with moderately to severely active ulcerative colitis and Crohn’s disease

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.

ENGINEERED FOR UC AND CD

Entyvio helps address inflammation where it occurs, in the GI tract1

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The body’s immune response in UC and CD triggers inflammation in the GI tract1

  • A discrete subset of memory T lymphocytes that preferentially migrate into the GI tract are known to express the α4β7 integrin, which binds to mucosal addressin cell adhesion molecule-1 (MAdCAM-1)1,20,21
  • This interaction facilitates lymphocyte homing to the gut and is an important contributor to the chronic inflammation found in UC and CD1,20-22

Immune response causes inflammation

  • The migration of certain lymphocytes into the gastrointestinal (GI) tract contributes to the chronic inflammation that is a hallmark of UC and CD.1,20,23

Entyvio binds to α4β7, inhibiting lymphocytes from entering GI tissue

  • Entyvio specifically binds to the α4β7 integrin, blocking its interaction with MAdCAM-1, which is mainly expressed on gut endothelial cells1
  • This inhibits the migration of these memory T lymphocytes from the blood into inflamed GI tissue1

Entyvio has a specific binding action designed for a gut-homing inflammatory pathway. Entyvio works differently from anti-TNFα agents.

Entyvio binds to α4β7, but does not bind to α4β1 or αEβ71

α4β7

  • Expressed: discrete subset of memory T lymphocytes that preferentially migrate into the GI tract1,6*
  • Targets MAdCAM-1, expressed mainly in the GI tract1,8
  • Entyvio binds only to α4β7. In addition, Entyvio blocks the interaction of the α4β7 integrin with MAdCAM-1 and does not antagonize the interaction of α4 integrins with the VCAM-1.1

α4β1

  • Expressed: most leukocytes except neutrophils6
  • Targets vascular cell adhesion molecule 1 (VCAM-1), expressed in the central nervous system (CNS), bone marrow, and skin8

αEβ7

  • Expressed: T cells, dendritic cells, and mast cells in mucosal tissues7
  • Targets E-cadherin, locating and retaining T lymphocytes within the epithelium of numerous tissues7
*
Also expressed on natural killer cells, mast cells, basophils, and monocytes.

Data from a pharmacokinetic study1

  • In a study of 14 healthy subjects, Entyvio did not affect the CD4+ lymphocyte cell counts, CD8+ lymphocyte cell counts, or the CD4+:CD8+ ratios in the cerebrospinal fluid (CSF)1
  • Entyvio was not detected in the CSF of 14 healthy subjects at 5 weeks after a single IV administration of 450 mg Entyvio (1.5 times the recommended dosage)1

IMPORTANT SAFETY INFORMATION

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  • 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.

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