These highlights do not include all the information needed to use ZERBAXA™ safely and effectively. See full prescribing information for ZERBAXA.
ZERBAXA (ceftolozane and tazobactam) for injection, for intravenous use
Initial U.S. Approval: 2014
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.
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Dosage and Administration (2) |
5/2015 |
INDICATIONS AND USAGE
ZERBAXA (ceftolozane and 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:
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Complicated Intra-abdominal Infections, used in combination with metronidazole (1.1)
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Complicated Urinary Tract Infections, including Pyelonephritis (1.2)
DOSAGE AND ADMINISTRATION
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ZERBAXA 1.5 gram (g) (ceftolozane 1 g and tazobactam 0.5 g) for injection, 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)
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Dosage in patients with impaired renal function (2.2):
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Estimated CrCl (mL/min)* |
Recommended Dosage Regimen for ZERBAXA (ceftolozane and tazobactam)† |
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30 to 50 |
ZERBAXA 750 mg (500 mg and 250 mg) intravenously every 8 hours |
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15 to 29 |
ZERBAXA 375 mg (250 mg and 125 mg) intravenously every 8 hours |
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End-stage renal disease (ESRD) on hemodialysis (HD) |
A single loading dose of ZERBAXA 750 mg (500 mg and 250 mg) followed by a ZERBAXA 150 mg (100 mg and 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
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ZERBAXA 1.5 g (ceftolozane and tazobactam) for injection supplied as a sterile powder for reconstitution in single-dose vials containing ceftolozane 1 g (equivalent to 1.147 g ceftolozane sulfate) and tazobactam 0.5 g (equivalent to 0.537 g tazobactam sodium) (3)
CONTRAINDICATIONS
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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. (4)
WARNINGS AND PRECAUTIONS
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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)
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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)
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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 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
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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)
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Higher incidence of adverse reactions was observed in patients aged 65 years and older. In complicated intra-abdominal infections, cure rates were lower in patients aged 65 years and older. (8.5)
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ZERBAXA has not been studied in pediatric patients. (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2015
