Vedolizumab

DEA Class; Rx

Common Brand Names; Entyvio

• Inflammatory Bowel Disease Agents; 
• Monoclonal Antibodies, Integrin Blockers

Monoclonal antibody that is a specific integrin receptor antagonist; given via IV infusion, dosed every 8 weeks for maintenance
Used for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults
Monitor for infusion and hypersensitivity reactions and increased risk for infection

Indicated for adults with moderate-to-severe active ulcerative colitis

Indicated for adults with moderate-to-severe active Crohn disease

Hypersensitivity

• Nasopharyngitis (13%)
• Headache (12%)
• Arthralgia (12%)
• Nausea (9%)
• Pyrexia (9%)
• Upper respiratory tract infection (7%)
• Fatigue (6%)
• Cough (5%)
• Bronchitis (4%)
• Influenza (4%)
• Back pain (4%)
• Rash (3%)
• Pruritus (3%)
• Sinusitis (3%)
• Oropharyngeal pain (3%)
• Pain in extremities (3%)

Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased BP and HR observed

Increased risk for developing infections; serious infections have also been reported, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis

Elevated liver transaminases and/or bilirubin reported; discontinue if jaundice occurs or other evidence of liver injury (eg, fatigue, anorexia, right upper abdominal discomfort); the combination of elevated transaminase and bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that may lead to death or the need for liver transplantation

Available pharmacovigilance data, data from the ongoing pregnancy registry, and data from published case reports and cohort studies in pregnant women have not identified an drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

Available published literature suggests presence of vedolizumab in human milk

Vedolizumab 

injection, lyophilized powder for reconstitution

• 300mg/vial (300mg/5mL after reconstituted)