Ceftolozane and Tazobactam

ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms in adult and pediatric patients (at least 32 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole. Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis. Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP). Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

ZERBAXA is an antibacterial drug.

Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 1 hour in adult patients. Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 1 hour in pediatric patients (at least 32 weeks gestational age) with cIAI or cUTI. Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 2 hours in pediatric patients (at least 32 weeks gestational age) with HABP/VABP. Recommended Dosage of ZERBAXA by Infection in Adult Patients.

ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane and tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class.

Decreased efficacy was observed in a Phase 3 cIAI trial in a subgroup of patients with baseline CrCl of 30 to 50 mL/min. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly. Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs. Exercise caution in patients with known hypersensitivity to beta-lactam antibacterial drugs. If an anaphylactic reaction to ZERBAXA occurs, discontinue the drug and institute appropriate therapy. Clostridioides difficile -Associated Diarrhea (has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Evaluate if diarrhea occurs.

The following serious reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity reactions Clostridioides difficile -associated diarrhea Adult cIAI, cUTI and HABP/VABP Patients: The most common adverse reactions in adult patients (≥5% in either the cIAI or cUTI indication) are nausea, diarrhea, headache, and pyrexia. The most common adverse reactions (≥5% in the HABP/VABP indication) are increase in hepatic transaminases, renal impairment/renal failure, and diarrhea. Pediatric cIAI, cUTI and HABP/VABP Patients: The most common adverse reactions in pediatric patients (≥7% in cIAI, cUTI, or HABP/VABP) are thrombocytosis, diarrhea, pyrexia, leukopenia, abdominal pain, vomiting, increased aspartate aminotransferase, increased alanine aminotransferase, and anemia.

Storage after reconstitution and dilution is described elsewhere in the labeling.