Zinplava FDA Approval History
FDA Approved: Yes (First approved October 21, 2016)
Brand name: Zinplava
Generic name: bezlotoxumab
Dosage form: Injection
Company: Merck
Treatment for: Prevention of Clostridium Difficile Infection Recurrence
Zinplava (bezlotoxumab) is a selective, fully-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.
Zinplava is administered as a single dose intravenous infusion over 60 minutes during antibacterial drug treatment for CDI.
In clinical trials, heart failure was reported more commonly in Zinplava-treated patients with a history of congestive heart failure, and it recommended that patients with a history of CHF should only receive Zinplava when the benefit outweighs the risk. Common side effects include nausea, fever, and headache.
Development timeline for Zinplava
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.