Ceftolozane

ZERBAXA is an antibacterial drug [see Clinical Pharmacology (12.4) ] .

• 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. ( 1.1 ) Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis.ICD-10: N39.0

• 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. 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.contraindicated

Administer all doses of ZERBAXA every 8 hours by intravenous infusion over 1 hour in adult patients. ( 2.1 ) 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. ( 2.2 ) 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. ( 2.2 ) Recommended Dosage of ZERBAXA by Infection in Adult Patients ( 2.1 ) Infection Dose Duration of Treatment cIAI Used in conjunction with metronidazole 500 mg intravenously every 8 hours ZERBAXA 1.5 g Administer all doses of ZERBAXA intravenously every 8 hours over 1 hour Provides 1 g ceftolozane and 0.5 g tazobactam 4 to 14 days cUTI, Including Pyelonephritis ZERBAXA 1.5 g 7 days HABP/VABP ZERBAXA 3 g Provides 2 g ceftolozane and 1 g tazobactam 8 to 14 days Recommended Dosage of ZERBAXA by infection in Pediatric Patients (at least 32 weeks gestational age) ( 2.2 ) Infection Dose Duration of Treatment cIAI Used in conjunction with metronidazole. ZERBAXA 30 mg/kg Provides 20 mg/kg ceftolozane and 10 mg/kg tazobactam. Pediatric patients with cIAI or cUTI weighing greater than 50 kg should not exceed a maximum dose of 1.5 g. up to a maximum dose of 1.5 g Administer all doses of ZERBAXA intravenously every 8 hours over 1 hour in pediatric patients with cIAI or cUTI. Provides 1 g ceftolozane and 0.5 g tazobactam.

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. ( 5.1 ) 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. ( 5.2 ) Clostridioides difficile -Associated Diarrhea (has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Evaluate if diarrhea occurs. ( 5.3 ) 5.1 Decreased Efficacy in Patients with Baseline Creatinine Clearance of 30 to 50 mL/min In a subgroup analysis of a Phase 3 cIAI trial of adult patients, clinical cure rates were lower in patients with baseline CrCl of 30 to 50 mL/min compared to those with CrCl greater than 50 mL/min (Table 6). The reduction in clinical cure rates was more marked in the ZERBAXA plus metronidazole arm compared to the meropenem arm. A similar trend was also seen in the cUTI trial. Monitor CrCl at least daily in patients with changing renal function and adjust the dosage of ZERBAXA accordingly [see Dosage and Administration (2.2) ] .

The following serious reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity reactions [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated diarrhea [see Warnings and Precautions (5.3) ] 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. ( 6.1 ) The most common adverse reactions (≥5% in the HABP/VABP indication) are increase in hepatic transaminases, renal impairment/renal failure, and diarrhea. ( 6.1 ) 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and also may not reflect rates observed in practice.

Geriatrics: Higher incidence of adverse reactions was observed in patients aged 65 years and older. In a Phase 3 cIAI trial, cure rates were lower in patients 65 years and older. ( 8.5 ) 8.1 Pregnancy Risk Summary There are no data available on ZERBAXA, ceftolozane or tazobactam use in pregnant women to allow assessment of a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Available data from published prospective cohort studies, case series, and case reports over several decades have not identified an association of cephalosporin use during pregnancy with major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data ). Neither ceftolozane nor tazobactam produced embryo-fetal toxicity when administered to rodents during the period of organogenesis at ceftolozane doses approximately 3.5 times higher in mice and 2 times higher in rats than the maximum recommended human dose (MRHD) of 2 grams every 8 hours based on plasma AUC comparison or at tazobactam doses approximately 10 times higher in rats than the MRHD of 1 gram every 8 hours based on body surface area comparison.

Metabolism

Ceftolozane and tazobactam pharmacokinetics are similar following single- and multiple-dose administrations. The C max and AUC of ceftolozane and tazobactam increase in proportion to dose.

In the event of overdose, discontinue ZERBAXA and provide general supportive treatment. ZERBAXA can be removed by intermittent hemodialysis. Approximately 66% of ceftolozane, 56% of tazobactam, and 51% of the tazobactam metabolite M1 were removed by dialysis. No information is available on the use of intermittent hemodialysis to treat overdosage.

• Dec 19, 2014NDANDA206829Cubist Pharms Llc

1. 1Off Label Use13814%
2. 2Product Use In Unapproved Indication12813%
3. 3No Adverse Event889.1%
4. 4Death818.4%
5. 5Product Use Issue677.0%
6. 6Pathogen Resistance545.6%
7. 7Drug Ineffective444.6%
8. 8Drug Resistance303.1%
9. 9Acute Kidney Injury293.0%
10. 10Incorrect Dose Administered262.7%
11. 11Pancytopenia262.7%
12. 12Pneumonia262.7%
13. 13Septic Shock242.5%
14. 14Thrombocytopenia242.5%
15. 15Encephalopathy232.4%

The 10 most recently updated of 38 ClinicalTrials.gov registrations naming Ceftolozane as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Clinical Outcomes With Ceftolozane-tazobactam for MDR Pseudomonas Infections
  Completed · Observational · 200 enrolled · Temple University
  NCT03510351updated 2026-05-22
• Ceftolozane-Tazobactam for Directed Treatment of Pseudomonas Aeruginosa Bacteremia and Pneumonia in Patients With Hematological Malignancies and Hematopoietic Stem Cell Transplantation
  Terminated · Phase 4 · Interventional · 17 enrolled · Weill Medical College of Cornell University
  NCT04673175updated 2026-01-21
• Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)
  Completed · Phase 1 · Interventional · 41 enrolled · Merck Sharp & Dohme LLC
  NCT04223752updated 2025-09-22
• Optimising TREATment for Severe Gram-Negative Bacterial Infections
  Recruiting · Phase 4 · Interventional · 600 enrolled · National University of Singapore
  NCT07004049updated 2025-06-04
• Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens
  Recruiting · Phase 4 · Interventional · 176 enrolled · Beneficência Portuguesa de São Paulo
  NCT06342115updated 2025-05-02
• Short Infusion Versus Prolonged Infusion of Ceftolozane-tazobactam Among Patients with Ventilator Associated-pneumonia
  Recruiting · Phase 3 · Interventional · 80 enrolled · University Hospital, Toulouse
  NCT03581370updated 2024-09-25
• Nosocomial Infections in ECMO Patients
  Recruiting · Observational · 200 enrolled · Policlinico Hospital
  NCT05566665updated 2024-07-10
• Use of New Antibiotics in Sweden
  Completed · Observational · 41 enrolled · Uppsala University
  NCT05048693updated 2024-06-18
• Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients
  Recruiting · Interventional · 226 enrolled · Instituto Nacional de Cancerologia de Mexico
  NCT06422533updated 2024-06-04
• Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy With a High Adsorption Membrane (oXiris®)
  Completed · Observational · 20 enrolled · Hospital Universitari de Bellvitge
  NCT04033029updated 2023-10-10

Frequently asked questions

How does Ceftolozane work?

ZERBAXA is an antibacterial drug [see Clinical Pharmacology (12.4) ] .

What is Ceftolozane used for?

According to FDA labeling, Ceftolozane carries indications including: 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. ( 1.1 ) Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ceftolozane?

Ceftolozane is classified as Cephalosporin Antibacterial, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.

What are the brand names for Ceftolozane?

Ceftolozane is marketed under brand names including Zerbaxa.

What are the contraindications for Ceftolozane?

Ceftolozane labeling lists contraindications including: 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. 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.. Always consult the full prescribing information and a clinician.