Generic Name and Formulations:
Vedolizumab 300mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.

Company:
Takeda Pharmaceuticals North America, Inc.
Indications for ENTYVIO:
Moderately-to-severely active ulcerative colitis: 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 TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or dependent on corticosteroids. Moderately-to-severely active Crohn’s disease: to achieve clinical response and remission, and corticosteroid-free remission in adults who have had inadequate response with, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or dependent on corticosteroids.

Adult:
Give by IV infusion over 30 minutes. ≥18yrs: 300mg at Weeks 0, 2, and 6, then every 8 weeks thereafter. Discontinue if no therapeutic benefit by Week 14.

Children:
<18yrs: not established.

Pharmacological Class:
Integrin receptor antagonist.

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 controlled. Consider withholding if severe infection develops. History of recurring severe infections. Consider tuberculosis screening. Monitor for neurological signs/symptoms (those associated with progressive multifocal leukoencephalopathy); withhold dosing if suspected; discontinue if confirmed. Discontinue if jaundice or significant liver injury occurs. Pregnancy (Cat. B). Nursing mothers.

Interactions:
Avoid concomitant natalizumab, TNF blockers. Caution with concomitant live vaccines.

Adverse Reactions:
Nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities.

Note:
Register pregnant patients exposed to Entyvio by calling (877) 825-3327.

How Supplied:
Single-use vials (20mL)—1