Entyvio Generic Name & Formulations
Legal Class
Rx
General Description
Vedolizumab 300mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Integrin receptor antagonist.
How Supplied
Single-use vial (20mL)—1
Manufacturer
Generic Availability
NO
Entyvio Indications
Indications
Moderately to severely active ulcerative colitis or Crohn’s disease.
Entyvio Dosage and Administration
Adult
Give by IV infusion over 30mins. ≥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.
Entyvio Contraindications
Not Applicable
Entyvio Boxed Warnings
Not Applicable
Entyvio Warnings/Precautions
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 infusion-related or hypersensitivity 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 [PML]); withhold dosing if suspected; permanently discontinue if confirmed. Discontinue if jaundice or significant liver injury occurs. Pregnancy. Nursing mothers.
Entyvio Pharmacokinetics
See Literature
Entyvio Interactions
Interactions
Avoid concomitant natalizumab, TNF blockers. Caution with concomitant live vaccines.
Entyvio Adverse Reactions
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; infusion-related or hypersensitivity reactions, PML.
Entyvio Clinical Trials
See Literature
Entyvio Note
Notes
Register pregnant patients exposed to Entyvio by calling (877) 825-3327.
Entyvio Patient Counseling
See Literature