bezlotoxumab
bezlotoxumab is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including ZINPLAVA. Available dosage form: injection, solution.
Drug Details
- Generic Name
- bezlotoxumab
- Brand Names
- ZINPLAVA
- Application Number
- BLA761046
- Sponsor
- MSD Ireland (Carlow)
- NDC Codes
- 2
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- BEZLOTOXUMAB
Indications and Usage
1 INDICATIONS AND USAGE 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. ( 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 ) 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. [See Dosage and Administration (2.1) .]