Company: Takeda Pharmaceuticals
Pharmacologic class: Integrin receptor antagonist
Active ingredients: Vedolizumab 300mg, per vial; lyophilized powder for intravenous (IV) infusion after reconstitution, preservative-free.
Indication: Moderately-to-severely active ulcerative colitis (UC): to induce and maintain clinical response and remission, to improve endoscopic mucosa appearance, and to achieve corticosteroid-free remission in adults who have had an inadequate or lost response with, or were intolerant to, a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or were dependent on corticosteroids. Moderately-to-severely active Crohn disease (CD): to achieve clinical response and remission, and corticosteroid-free remission, in adults who have had an inadequate response with, or were intolerant to, a TNF blocker or immunomodulator or in adults who have had an inadequate response with, were intolerant to, or were dependent on corticosteroids.
Pharmacology: Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7 integrin and blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue.
The interaction of the α4β7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of UC and CD.
Clinical trials: The safety and efficacy of Entyvio were evaluated in 2 randomized, double-blind, placebo-controlled trials in adults with moderately-to-severely active UC defined as Mayo score of 6 to 12 with endoscopy subscore of 2 or 3.
Results in these studies (UC Trials I and II) demonstrated that compared with patients treated with placebo, a greater percentage of patients treated with Entyvio achieved and maintained clinical response, achieved and maintained clinical remission, achieved corticosteroid-free clinical remission, and experienced improved endoscopic appearance of the mucosa at weeks 6 and 52.
Entyvio safety and efficacy were evaluated in 3 randomized, double-blind, placebo-controlled trials in adults with moderately-to-severely active CD (Crohn’s Disease Activity Index [CDAI] score of 220 to 450).
Results in CD Trial III showed that compared with persons treated with placebo, a greater percentage of patients treated with Entyvio achieved clinical response, clinical remission, and corticosteroid-free clinical remission at week 52.
For more clinical trial data, see full labeling.
Adults: Give by IV infusion over 30 minutes. Persons ≥18 years: 300 mg at weeks 0, 2, and 6, then every 8 weeks thereafter. Discontinue if no therapeutic response by week 14.
Children: <18 years: not established.
Warnings/Precautions: Complete all immunizations according to current guidelines before initiating. Monitor for hypersensitivity reactions during and after infusion. Have epinephrine and antihistamines available. Discontinue if anaphylaxis or other serious allergic reactions occur.
Active, severe infections: not recommended until resolved. Consider withholding if severe infection develops. History of recurring severe infections. Consider tuberculosis screening. Monitor for neurologic signs/symptoms (e.g., progressive multifocal leukoencephalopathy [PML]); withhold dosing if suspected; discontinue if confirmed. Discontinue if jaundice or significant liver injury occurs. Pregnancy (Category B). Nursing mothers.
Interactions: Avoid using with natalizumab, TNF blockers. Caution with concomitant live vaccines.
Adverse reactions: Nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper-respiratory infection, fatigue, cough, bronchitis, flu, back pain, rash, pruritus, sinusitis, oropharyngeal pain, extremities pain, hypersensitivity reactions, PML, liver injury.
Note: Register pregnant patients exposed to Entyvio by calling (877) 825-3327.
How supplied: Single-use vials (20mL)—1
For more information, call (877) 825-3327 or visit www.Entyvio.com.