Bezlotoxumab

ZINPLAVA™ is 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. 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. Limitation of Use: ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

ZINPLAVA (bezlotoxumab) is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. Mechanism of Action Bezlotoxumab is a human monoclonal antibody that binds C. difficile toxin B with an equilibrium dissociation constant (K d ) of <1×10 -9 M. Bezlotoxumab inhibits the binding of toxin B and prevents its effects on mammalian cells. Bezlotoxumab does not bind to C. difficile toxin A.

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. 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.

None. 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.

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

Since ZINPLAVA is eliminated by catabolism, no metabolic drug-drug interactions are expected.

Store in a refrigerator, 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do Not Freeze. Do Not Shake.