ZERBAXA®

(ceftolozane and tazobactam) for injection (1.5 g), for intravenous use

Ordering

Ordering susceptibility tests

Below are resources to help you learn about verification for susceptibility testing for ZERBAXA.

Verification of gradient diffusion strips for ZERBAXA

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Verification of disk diffusion tests for ZERBAXA

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Susceptibility tests for ceftolozane and tazobactam

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Ordering clinical isolates

To order clinical isolates to perform verification testing for ceftolozane and tazobactam, contact the CDC or send requests via the following link: www.cdc.gov/drugresistance/resistance-bank/currently-available.html.

Ordering susceptibility tests from Hardy Diagnostics

Ceftolozane and tazobactam susceptibility disks are available from Hardy Diagnostics.

Visit hardydiagnostics.com for complete instructions for use or call 1-800-266-2222.

Susceptibility Disks from Hardy Diagnostics for Susceptibility Testing
Description Catalog number
Ceftolozane/tazobactam 1x50 cartridge (30 mg/10 μg) Z9341
Ceftolozane/tazobactam 5x50 cartridge (30 mg/10 μg) Z9345
  • Available in single cartridge (Z9341) or packs of 5 (Z9345)
  • Compatible with BBL dispenser
  • For in vitro diagnostic use only. Observe approved biohazard precautions and aseptic techniques. This product is to be used only by adequately trained and qualified laboratory personnel. Sterilize all biohazard waste before disposal.

FDA- and CLSI-approved susceptibility interpretive criteria for ceftolozane/tazobactam

Pathogen Minimum inhibitory concentrations (mcg/mL) Disk diffusion zone diameter (mm)
Susceptible Intermediate Resistant Susceptible Intermediate Resistant
Enterobacteriaceae ≤2/4 4/4 ≥8/4 ≥21 18–20 ≤17
Pseudomonas aeruginosa ≤4/4 8/4 ≥16/4 ≥21 17–20 ≤16

HardyDisk is a registered trademark of Hardy Diagnostics.

Ordering susceptibility tests from Thermo Fisher

Ceftolozane and tazobactam are available from Thermo Fisher Scientific on Microbroth Dilution Thermo ScientificTM SensititreTM Custom MIC Plates.

For more information, contact your local representative at microbiology@thermofisher.com or visit thermofisher.com/AST.

Ceftolozane and Tazobactam from Thermo Fisher Scientific for Susceptibility Testing

  • Manual to fully automated plate reading
  • True minimum inhibitory concentration (MIC) results
  • For in vitro diagnostic use only. Observe approved biohazard precautions and aseptic techniques. This product is to be used only by adequately trained and qualified laboratory personnel. Sterilize all biohazard waste before disposal.

FDA- and CLSI-approved susceptibility interpretive criteria for ceftolozane and tazobactam

Pathogen Minimum inhibitory concentrations (mcg/mL)
Susceptible Intermediate Resistant
Enterobacteriaceae ≤2/4 4/4 ≥8/4
Pseudomonas aeruginosa ≤4/4 8/4 ≥16/4

(a) The Sensititre 18–24 hour MIC or breakpoint susceptibility system with ceftolozane and tazobactam is FDA-cleared in the dilution range of 0.03/4-64/4 μg/mL.

Thermo Scientific and Sensititre are trademarks of Thermo Fisher Scientific Inc. and its subsidiaries.

Ordering ETEST ® strips from bioMérieux

Ceftolozane and tazobactam ETEST ® C/T 256 strips are available from bioMérieux.

For ordering information, visit biomerieux-usa.com/clinical/etest.

ETEST® Strips from bioMérieux for Antimicrobial Susceptibility Testing

  • The ETEST® C/T 256 strip is an in vitro quantitative technique of antimicrobial susceptibility testing (AST) for determining a minimum inhibitory concentration (MIC) for ceftolozane/tazobactam.
  • For in vitro diagnostic use only. Observe approved biohazard precautions and aseptic techniques. This product is to be used only by adequately trained and qualified laboratory personnel. Sterilize all biohazard waste before disposal.
Description μg/mL Strips/box Ref.
ETEST® ceftolozane/tazobactam

Each strip contains:

  • Ceftolozane MIC range: 0.016-256 μg/mL
  • Tazobactam: 4 μg/mL
 Single pack: 30 strips 414 445

FDA- and CLSI-approved susceptibility interpretive criteria for ceftolozane and tazobactam

Pathogen Minimum inhibitory concentrations (mcg/mL)
Susceptible Intermediate Resistant
Enterobacteriaceae ≤2/4 4/4 ≥8/4
Pseudomonas aeruginosa ≤4/4 8/4 ≥16/4

ETEST is a registered trademark of bioMérieux SA or one of its subsidiaries.

Definitions

AST = antimicrobial susceptibility testing 

CLSI = Clinical and Laboratory Standards Institute 

MIC = minimum inhibitory concentration

Indications

ZERBAXA is indicated in adult patients for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.

ZERBAXA used in combination with metronidazole is indicated in adult patients for the treatment of complicated intra-abdominal infections (cIAI) caused by the following Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.

Usage

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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Selected Safety Information

  • Patients with renal impairment: Decreased efficacy of ZERBAXA has been observed in patients with baseline creatinine clearance (CrCl) of 30 to ≤50 mL/min. In a clinical trial, patients with cIAIs with CrCl >50 mL/min had a clinical cure rate of 85.2% when treated with ZERBAXA plus metronidazole vs 87.9% when treated with meropenem. In the same trial, patients with CrCl 30 to ≤50 mL/min had a clinical cure rate of 47.8% when treated with ZERBAXA plus metronidazole vs 69.2% when treated with meropenem. A similar trend was also seen in the cUTI trial. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly.
  • Hypersensitivity: ZERBAXA is contraindicated in patients with known serious hypersensitivity to ceftolozane/tazobactam, piperacillin/tazobactam, or other members of the beta-lactam class. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. Before initiating therapy with ZERBAXA, make careful inquiry about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If an anaphylactic reaction to ZERBAXA occurs, discontinue use and institute appropriate therapy.
  • Clostridium difficile–associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.
  • Development of drug-resistant bacteria: Prescribing ZERBAXA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
  • Adverse reactions: The most common adverse reactions occurring in ≥5% of patients were headache (5.8%) in the cUTI trial, and nausea (7.9%), diarrhea (6.2%), and pyrexia (5.6%) in the cIAI trial.

Before prescribing ZERBAXA, please read the accompanying Prescribing Information.

AINF-1159589-017904/18