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.

Clinical cases for UC and CD

Entyvio—a tool designed for your patients with UC or CD who are ready for a different treatment approach.1

See CD clinical case

UC clinical case*
Moderate UC, unable to taper steroids
CD clinical case*
Moderate CD, older adult
Patient information
  • Male, age 27
  • Diagnosed with moderate, left-sided UC 3 years ago
  • Concerned about repeated steroid use
  • Currently, symptoms worsen with attempts to taper steroids
  • Female, age 61
  • Diagnosed with moderate, ileocolonic CD 4 years ago by colonoscopy and MRE
  • Has type 2 diabetes, currently controlled
Treatment history
  • Treated with oral and rectal mesamaline since initial diagnosis13
  • Over the past 18 months, has required 3 supplemental courses of oral CS due to symptom flares13
  • Initially treated with CS followed by maintenance 6-mercaptopurine 100 mg/day16,17
  • Has required 2 courses of oral CS over the last 12 months for symptom flares16
  • Symptoms have increased in severity over the last 6 months
Clinical assessment14,18
Mayo score: 7
  • Patient reports 3-4 stools more than normal
  • Occasional blood in the stool
  • Endoscopic evaluation to splenic flexure reveals erythema, friability, and reduced vascular pattern
  • Global assessment of moderate colitis
CDAI score: 281
  • Patient currently experiencing 5-7 loose stools per day, with intermediate abdominal pain and poor general well-being
  • 5% reduction in body weight over the last 3 months
  • Taking antidiarrheal medication
Additional laboratory tests
  • Fecal calprotectin15 380 µg/g
  • CRP15 12 mg/L
  • Stool negative for C difficile13
  • Fecal calprotectin19 290 µg/g
  • Stool negative for C difficile16

UC clinical case*

Moderate UC, unable to taper steroids

Patient information

  • Male, age 27
  • Diagnosed with moderate, left-sided UC 3 years ago
  • Concerned about repeated steroid use
  • Currently, symptoms worsen with attempts to taper steroids

Treatment history

  • Treated with oral and rectal mesamaline since initial diagnosis13
  • Over the past 18 months, has required 3 supplemental courses of oral CS due to symptom flares13

Clinical assessment14

Mayo score: 7
  • Patient reports 3-4 stools more than normal
  • Occasional blood in the stool
  • Endoscopic evaluation to splenic flexure reveals erythema, friability, and reduced vascular pattern
  • Global assessment of moderate colitis

Additional laboratory tests

  • Fecal calprotectin15 380 µg/g
  • CRP15 12 mg/L
  • Stool negative for C difficile13
CS=corticosteroids; CRP=C-reactive protein; MRE=magnetic resonance enterography.
*
Hypothetical clinical case for educational basis and/or clinical discussion.
Composite score based on 4 clinical factors. Demonstrating an effect on a composite multiple clinical factor does not represent a clear effect on any of the individual components.
Weighted composite score based on 8 clinical factors. Demonstrating an effect on a composite multiple clinical factor does not represent a clear effect on any of the individual components.

CD clinical case*

Moderate CD, older adult

Patient information

  • Female, age 61
  • Diagnosed with moderate, ileocolonic CD 4 years ago by colonoscopy and MRE
  • Has type 2 diabetes, currently controlled

Treatment history

  • Initially treated with CS followed by maintenance 6-mercaptopurine 100 mg/day16,17
  • Has required 2 courses of oral CS over the last 12 months for symptom flares16
  • Symptoms have increased in severity over the last 6 months

Clinical assessment18

CDAI score: 281
  • Patient currently experiencing 5-7 loose stools per day, with intermediate abdominal pain and poor general well-being
  • 5% reduction in body weight over the last 3 months
  • Taking antidiarrheal medication

Additional laboratory tests

  • Fecal calprotectin19 290 µg/g
  • Stool negative for C difficile16
CS=corticosteroids; CRP=C-reactive protein; MRE=magnetic resonance enterography.
*
Hypothetical clinical case for educational basis and/or clinical discussion.
Composite score based on 4 clinical factors. Demonstrating an effect on a composite multiple clinical factor does not represent a clear effect on any of the individual components.
Weighted composite score based on 8 clinical factors. Demonstrating an effect on a composite multiple clinical factor does not represent a clear effect on any of the individual components.

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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