Integrin Receptor Antagonists

Integrin Receptor Antagonist

Colitis, Ulcerative

Crohn Disease

Enteritis

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Vedolizumab, an integrin receptor antagonist, is a humanized IgG<span class="Sub">1 </span>monoclonal antibody produced in Chinese hamster ovary cells that binds to the human α4β7 integrin. ENTYVIO has an approximate molecular weight of 147 kilodaltons.</p><div class="Section" data-sectioncode="42229-5"><a name="section-9.1"></a><p></p><p class="First"><span class="Italics Underline">Intravenous ENTYVIO</span></p><p>ENTYVIO (vedolizumab) for injection is supplied as a sterile, white to off-white, preservative-free, lyophilized cake for intravenous infusion. After reconstitution with 4.8 mL Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, the resulting concentration is 60 mg/mL with a deliverable volume of 5 mL (300 mg) and the resulting pH is approximately 6.3.</p><p>Each single-dose vial contains 300 mg vedolizumab, arginine hydrochloride (131.7 mg), histidine (23 mg), histidine monohydrochloride (21.4 mg), polysorbate 80 (3 mg), and sucrose (500 mg).</p></div><div class="Section" data-sectioncode="42229-5"><a name="section-9.2"></a><p></p><p class="First"><span class="Italics Underline">Subcutaneous ENTYVIO</span></p><p>ENTYVIO (vedolizumab) injection is supplied as a sterile, clear to moderately opalescent, colorless to slightly yellow, preservative-free solution for subcutaneous administration.</p><p>Each single-dose prefilled syringe or single-dose prefilled pen (ENTYVIO PEN) contains 108 mg vedolizumab, arginine hydrochloride (17.77 mg), citric acid monohydrate (0.18 mg), histidine (3.86 mg), histidine monohydrochloride (1.86 mg), polysorbate 80 (1.35 mg), sodium citrate dihydrate (4.71 mg) and Sterile Water for Injection, USP, at a pH of 6.5.</p></div></section>

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