These highlights do not include all the information needed to use ZERBAXA™ safely and effectively. See full prescribing information for ZERBAXA.
ZERBAXA (ceftolozane/tazobactam) for Injection, for intravenous use
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
ZERBAXA (ceftolozane/tazobactam) is a combination product consisting of a cephalosporin-class antibacterial drug and a beta-lactamase inhibitor indicated for the treatment of the following infections caused by designated susceptible microorganisms:
-
Complicated Intra-abdominal Infections, used in combination with metronidazole (1.1)
-
Complicated Urinary Tract Infections, including Pyelonephritis (1.2)
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 infections that are proven or strongly suspected to be caused by susceptible bacteria.
DOSAGE AND ADMINISTRATION
-
ZERBAXA (ceftolozane/tazobactam) for Injection, 1.5 g (1 g/0.5 g) every 8 hours by intravenous infusion administered over 1 hour for patients 18 years or older with creatinine clearance (CrCl) greater than 50 mL/min. (2.1)
-
Dosage in patients with impaired renal function (2.2):
|
Estimated CrCl (mL/min) |
Recommended Dosage Regimen for ZERBAXA |
|
30 to 50 |
Ceftolozane/tazobactam 750 mg (500 mg/250 mg) intravenously every 8 hours |
|
15 to 29 |
Ceftolozane/tazobactam 375 mg (250 mg/125 mg) intravenously every 8 hours |
|
End-stage renal disease (ESRD) on hemodialysis (HD) |
A single loading dose of ceftolozane/tazobactam 750 mg (500 mg/250 mg) followed by a 150 mg (100 mg/50 mg) maintenance dose administered intravenously every 8 hours for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis) |
DOSAGE FORMS AND STRENGTHS
ZERBAXA for Injection (ceftolozane/tazobactam) 1 g/0.5 g powder for reconstitution in single-dose vials containing 1 g ceftolozane (equivalent to 1.147 g ceftolozane sulfate) and 0.5 g tazobactam (equivalent to 0.537 g tazobactam sodium) (3)
CONTRAINDICATIONS
ZERBAXA is contraindicated in patients with known serious hypersensitivity to ceftolozane/tazobactam, piperacillin/tazobactam, or other members of the beta-lactam class. (4)
WARNINGS AND PRECAUTIONS
-
Decreased efficacy in 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. (5.2)
-
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZERBAXA. eva luate if diarrhea occurs. (5.3)
ADVERSE REACTIONS
The most common adverse reactions (≥ 5% in either indication) are nausea, diarrhea, headache and pyrexia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Cubist Pharmaceuticals at 1-877-282-4786 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
-
Dosage adjustment is required in patients with moderately or severely impaired renal function and in patients with end-stage renal disease on hemodialysis (HD). (2.2, 8.5, 8.6, 12.3)
-
Higher incidence of adverse reactions was observed in patients age 65 years and older. In complicated intra-abdominal infections, cure rates were lower in patients age 65 years and older. (8.5)
-
ZERBAXA has not been studied in pediatric patients. (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2014
