ZINPLAVA is a human monoclonal antibody that binds to Clostridium difficile toxin B, indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence. (1)
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. (1)

• Administer ZINPLAVA during antibacterial drug treatment for CDI. (2.1)
• 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. (2.3)

Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial. (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

Heart Failure: Was reported more commonly in ZINPLAVA-treated patients with a history of congestive heart failure (CHF) in the two Phase 3 clinical trials. In patients with a history of CHF, ZINPLAVA should be reserved for use when the benefit outweighs the risk. (5.1)

Most common adverse reactions (reported in ≥4% of patients) included nausea, pyrexia, and headache. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.