ENTYVIO is an integrin receptor antagonist indicated for:

Adult Ulcerative Colitis (UC) (1.1)

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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:

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inducing and maintaining clinical response

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inducing and maintaining clinical remission

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improving endoscopic appearance of the mucosa

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achieving corticosteroid-free remission

Adult Crohn's Disease (CD) (1.2)

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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:

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achieving clinical response

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achieving clinical remission

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achieving corticosteroid-free remission

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Recommended dosage in UC and CD: 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter. ( 2.3)

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Discontinue ENTYVIO in patients who do not show evidence of therapeutic benefit by Week 14. ( 2.3)

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Must reconstitute ENTYVIO lyophilized powder with Sterile Water for injection and must dilute in 250 mL of sterile 0.9% Sodium Chloride injection prior to administration. See Full Prescribing Information for complete reconstitution and dilution instructions. ( 2.4)

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Administer infusion solution within four hours of reconstitution and dilution. ( 2.4)

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Bring patients up to date with all immunizations (according to current immunization guidelines) before initiating treatment with ENTYVIO. ( 2.2)

For injection: 300 mg of lyophilized vedolizumab in a single-use 20 mL vial. (3)

Patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients. (4)

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Hypersensitivity Reactions (including anaphylaxis): Discontinue ENTYVIO if anaphylaxis or other serious allergic reactions occur. ( 5.1)

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Infections: Treatment with 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. ( 5.2)

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Progressive Multifocal Leukoencephalopathy: Although no cases have been observed in ENTYVIO clinical trials, JCV 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. ( 5.3)

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. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.