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

Clinical trials evaluated safety in >3300 adults1

Including more than 800 patients who received Entyvio for more than 2 years

Safety profile from UC Trials I & II and CD Trials I & III

Infusion-related reactions (IRRs)

  • 4% of patients treated with Entyvio experienced an IRR, including anaphylaxis (1 of 1434), versus 3% of patients on placebo. Allergic reactions included dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate1
  • Most frequently observed IRRs: nausea, headache, pruritus, dizziness, fatigue, pyrexia, urticaria, and vomiting. Observed IRRs generally occurred within the first 2 hours after the infusion and resolved with no treatment or following antihistamine and/or IV hydrocortisone treatment1

Infections

Infection rates with Entyvio: 0.85 per patient-year; placebo: 0.7 per patient-year1

  • The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, sinusitis, and urinary tract infection
  • 2% of patients discontinued Entyvio due to infections

Serious infection rates with Entyvio: 0.07 per patient-year; placebo: 0.06 per patient-year1

  • Serious infections included anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis

Progressive multifocal leukoencephalopathy (PML)

  • In clinical trials, no cases of PML were reported1
  • Since the 2014 launch of Entyvio through early November 20154, no cases of PML have been reported through post-marketing surveillance3
  • The risk of PML cannot be ruled out1
    • John Cunningham (JC) virus infection resulting in PML and death has occurred in patients treated with a different integrin antagonist. No claims of comparative safety to other integrin antagonists can be made based on this data

Liver injury

Entyvio should be discontinued in patients with jaundice or other evidence of significant liver injury1

Three patients reported serious adverse reactions of hepatitis with Entyvio. One additional case of serious hepatitis was seen in the open-label trial1

  • These adverse reactions occurred following 2 to 5 Entyvio doses; however, it is unclear if the reactions indicated drug-induced or autoimmune etiology
  • There have been reports of elevations of transaminases and/or bilirubin in patients receiving Entyvio
  • All patients recovered following discontinuation of therapy with or without treatment with corticosteroids

Adverse reactions (ARs)1

Adverse reactions were reported in 52% of patients treated with Entyvio (n=1434) and 45% of patients treated with placebo (n=297)1

  • Over 52 weeks, 7% of patients treated with Entyvio experienced serious adverse reactions compared to 4% of patients treated with placebo

Malignancies (excluding dysplasia and basal cell carcinoma) were reported in 0.4% (6 of 1434) of patients treated with Entyvio and in 0.3% (1 of 297) of patients treated with placebo1

  • The number of malignancies in the clinical trials was small; however, long-term exposure was limited

The following table lists adverse reactions that occurred in ≥3% of Entyvio-treated patients and ≥1% higher than in placebo (UC Trials I and II* and CD Trials I and III*).

Adverse reaction Entyvio (n=1434) Placebo (n=297)
Nasopharyngitis 13% 7%
Headache 12% 11%
Arthralgia 12% 10%
Nausea 9% 8%
Pyrexia 9% 7%
Upper respiratory tract infection 7% 6%
Fatigue 6% 3%
Cough 5% 3%
Bronchitis 4% 3%
Influenza 4% 2%
Back pain 4% 3%
Rash 3% 2%
Pruritus 3% 1%
Sinusitis 3% 1%
Oropharyngeal pain 3% 1%
Pain in extremities 3% 1%
*
Data from patients receiving open-label Entyvio treatment at Weeks 0 and 2 (prior to entry into UC Trial II and CD Trial III) and from Weeks 6 to 52 (nonresponders at Week 6 of UC Trial I and CD Trial I ) are included.
Patients who received Entyvio for up to 52 weeks.
Patients who received placebo for up to 52 weeks.

Immunogenicity

The rate of detectable anti-vedolizumab antibodies at any time during the 52 weeks of continuous treatment with Entyvio was 4%1

  • The frequency of antibodies detected in patients who received Entyvio was 13% at 24 weeks after the last dose of study drug
  • 56 of 1434 patients (4%) who received continuous treatment with Entyvio were anti-vedolizumab antibody-positive at any time during treatment
  • 9 of 56 patients were persistently positive (at 2 or more study visits) for anti-vedolizumab antibody, and 33 of 56 developed neutralizing antibodies to vedolizumab. Among 8 of these 9 subjects, 6 had undetectable vedolizumab concentrations and 2 had reduced vedolizumab concentrations. None of the 9 subjects with persistently positive anti-vedolizumab antibody achieved clinical remission at Weeks 6 or 52 in the controlled trials

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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