ZINPLAVA (bezlotoxumab) is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects [see Microbiology.

ZINPLAVA is a human monoclonal antibody that binds to Clostridioides difficile toxin B, indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.

•Administer ZINPLAVA during antibacterial drug treatment for CDI. •The recommended dose is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. (2.2) •Dilute prior to intravenous infusion. Administer via a low-protein binding 0.2 micron to 5 micron in-line or add-on filter. See Full Prescribing Information for dilution and administration instructions.

•Adult Patients: The most common adverse reactions (reported in ≥4% of adult patients) included nausea, pyrexia, and headache. •Pediatric Patients: The most common adverse reactions (reported in >10% of pediatric patients) were pyrexia and headache.

None.

Heart Failure: Was reported more commonly in ZINPLAVA-treated patients with a history of congestive heart failure (CHF) in Trial 1 and Trial 2. In patients with a history of CHF, ZINPLAVA should be reserved for use when the benefit outweighs the risk.