What is ZERBAXA?
ZERBAXA is a prescription medication that comprises two active ingredients:
- Ceftolozane is an antibiotic that is classified as a “cephalosporin.” Ceftolozane is effective against a wide variety of bacteria that might cause infection.
- Tazobactam is a member of the class of drugs known as “beta-lactamase inhibitors.” Tazobactam may enhance the effectiveness of ceftolozane against some resistant bacteria.
Ceftolozane and tazobactam combined kill a greater variety of germs.
ZERBAXA uses
ZERBAXA is used to treat the following conditions in adults aged 18 years or older:
- Complicated abdominal and urinary system infections, including pyelonephritis.
- Nosocomial pneumonia (lung infection that can occur in hospitalized or recently hospitalized patients), including “ventilator-associated pneumonia” (an infection of the lungs that can occur while on a respirator).
- ZERBAXA may have been recommended for another purpose by your doctor. Inquire with your physician if you have any concerns about why ZERBAXA was recommended for you.
ZERBAXA is only available by prescription from a physician. ZERBAXA is not addictive.
Administration and dosing
Dosage for patients with hospital-acquired bacterial pneumonia (HABP/VABP):
- For adult patients with HABP/VABP with a creatinine clearance (CrCl) greater than 50 mL/min, the recommended dose of ZERBAXA is 3 grams (two 1.5 g vials) during a 1-hour period every 8 hours for 8 to 14 days.
- CrCl of 30 to 50, 1.5 g (1 g and 0.5 g) intravenously every 8 hours in patients with HABP/VABP
- CrCl of15 to 29, 750 mg (500 mg and 250 mg) intravenously every 8 hours
- For patients with end-stage renal disease receiving hemodialysis, a single loading dose of 2.25 g (1.5 g and 0.75 g) followed by a 450-mg (300 mg and 150 mg) maintenance dose 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).
Contraindications
- Hypersensitivity to any of the active ingredients
- Hypersensitivity to any cephalosporin antibacterial agent
- Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other beta-lactam antibacterial agent (e.g., penicillins or carbapenems).
Safety information
• Patients with renal impairment: ZERBAXA’s efficacy has been reported to be decreased in patients having a baseline CrCl of 30 to 50 mL/min. Clinical cure rates of 85.2 percent for patients with cIAIs and CrCl > 50 mL/min when treated with ZERBAXA with metronidazole vs 87.9 percent when treated with meropenem were seen in a clinical investigation. Patients with CrCl 30 to 50 mL/min had a clinical cure rate of 47.8 percent when treated with ZERBAXA with metronidazole, compared to 69.2 percent when treated with meropenem, in the same experiment. Similarly, a similar pattern was observed in the cUTI experiment. Patients having a CrCl of less than 50 mL/min must have their dose adjusted. All ZERBAXA dosages are delivered over a one-hour period. In patients with fluctuating renal function, monitor CrCl at least daily and adjust the ZERBAXA dose accordingly.
• Hypersensitivity: ZERBAXA is contraindicated in patients who have a history of severe hypersensitivity to either of the active ingredients in ZERBAXA (ceftolozane/tazobactam), piperacillin/tazobactam, or other beta-lactam antibiotics. Patients using beta-lactam antibacterials have experienced severe and occasionally deadly hypersensitivity (anaphylactic) reactions. Prior to commencing ZERBAXA medication, conduct a thorough history check for past hypersensitivity responses to cephalosporins, penicillins, or other beta-lactam antibiotics. In the event of an allergic reaction to ZERBAXA, discontinue use and seek immediate treatment.
• Clostridioides difficile-associated diarrhea (CDAD) has been described in association with practically all systemic antibacterial medications, including ZERBAXA. A thorough medical history is important because CDAD has been documented to occur more than two months following antibacterial agent administration. If CDAD is confirmed, all antibiotics not specifically intended against C. difficile should be withdrawn as soon as feasible.
• Bacterial drug resistance development: Without a confirmed or strongly suspected bacterial infection or a preventive indication, prescribing ZERBAXA is unlikely to benefit the patient and may result in the development of drug-resistant bacteria.
• Adverse responses: The most frequently reported adverse events in 5% of participants in the HABP/VABP trial were elevated hepatic transaminase (11.9%), renal impairment/renal failure (8.9 percent), and diarrhea (6.4 percent ).
• In the cUTI and cIAI studies, the most prevalent side events 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.
ZERBAXA Cost
Zerbaxa intravenous powder for injection (1 g-0.5 g) costs approximately $1,317 for a supply of ten powders for injection, depending on the drugstore you visit. Prices are applicable just for cash-paying consumers and do not apply to insurance policies.
