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

Starting your appropriate patients on a different approach to UC and CD treatment

300-mg dose for adult patients1
No weight-based adjustments required

30-minute infusion at Weeks 0, 2, and 6, then every 8 weeks thereafter

~6 infusions per year after induction1

Prior to initiating treatment with Entyvio, all patients should be brought up to date with all immunizations.1

Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14.1

Monitoring

Entyvio should be administered by a healthcare professional prepared to manage hypersensitivity reactions, including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use. Observe patients during infusion and until the infusion is complete.1

Concomitant therapies

Entyvio can be administered concomitantly with aminosalicylates, steroids, or immunomodulators.1

Entyvio is administered as an IV infusion over 30 minutes1

Administration1

  • Do not administer as an IV push or bolus
  • Must reconstitute Entyvio lyophilized powder with sterile water for injection and dilute in 250 mL of sterile 0.9% sodium chloride injection prior to administration
  • Administer infusion solution within 4 hours of reconstitution and dilution
  • Please see full Prescribing Information for complete reconstitution and dilution instructions

How supplied and handling1

  • Entyvio is supplied in sterile, 20-mL, single-use glass vials, containing 300 mg of vedolizumab as a white to off-white cake
    • NDC 64764-300-20: 300-mg single-dose vial in individual carton
  • Refrigerate unopened vials at 2° to 8°C (36° to 46°F). Retain in original package to protect from light

Entyvio dosing and administration video

For demonstrative purposes only. Please see full Prescribing Information for complete reconstitution and dilution instructions.

This module is also available as a download for EntyvioHCP members

Download full Prescribing Information

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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