FDA Approves Zerbaxa for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

June 5, 2019

Zerbaxa is a cephalosporin antibacterial and beta-lactamase inhibitor combination drug originally approved for abdominal and urinary tract infections.

The FDA has approved an expanded indication for Zerbaxa (ceftolozane and tazobactam, Merck). The combination drug is now approved to treat hospital-acquired and ventilator-associated bacterial pneumonia in adult patients. 

The cephalosporin antibacterial and beta-lactamase inhibitor combination drug gained this approval based on results from a recent multinational double-blind study that compared Zerbaxa to another antibacterial drug, according to an FDA release. When the results from all 726 adult patients were compared, the researchers concluded that mortality and cure rates between Zerbaxa and the comparator drug were similar enough to warrant Zerbaxa’s effectiveness. Adverse events reported during the clinical trial included elevated liver enzyme levels, renal impairment or failure, and diarrhea. 

Zerbaxa was originally approved by the FDA in 2014, and is also indicated for complicated intra-abdominal infections and complicated urinary tract infections. Zerbaxa should be administered every eight hours by intravenous infusion, consisting of one-hour administration periods. For doses larger than 1.5 g, reconstitute a second vial in the same manner as the first, withdraw an appropriate volume, and add to the same infusion bag. See prescribing information for more exact details. 

Zerbaxa is contraindicated for patients with known serious hypersensitivity to components of Zerbaxa, piperacillin/tazobactam, or other members of the betalactam class. 

Full Prescribing Information     Zerbaxa Healthcare Professional Site