ZERBAXA

What it is

ZERBAXA is a medicine containing 1000 mg of ceftolozane (as ceftolozane sulfate) and 500 mg tazobactam (as tazobactam sodium) per vial. ZERBAXA is a white to yellow powder for solution. ZERBAXA is intended for intravenous infusion. ZERBAXA is an antibacterial drug product composed of a cephalosporin and a beta-lactamase inhibitor.

Approved indications

ZERBAXA is indicated for the treatment of adult and paediatric (birth to less than 18 years of age) patients with the following infections caused by designated susceptible microorganisms: — Complicated intra-abdominal infections in combination with metronidazole — Complicated urinary tract infections, including pyelonephritis

ZERBAXA is also indicated for the treatment of the following infection in adults (18 years or older): — Nosocomial pneumonia, including ventilator-associated pneumonia (VAP)

Dosing overview

For adult patients 18 years or older with creatinine clearance greater than 50 mL/min, the recommended dose of ZERBAXA is 1000 mg ceftolozane/500 mg tazobactam every 8 hours for complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis. For nosocomial pneumonia including ventilator-associated pneumonia, the recommended dose is 2000 mg ceftolozane/1000 mg tazobactam every 8 hours. The recommended infusion time is 1 hour. For paediatric patients from birth to less than 18 years of age with an estimated glomerular filtration rate greater than 50 mL/min/1.73 m², the dose for complicated intra-abdominal infections and complicated urinary tract infections including pyelonephritis is 30 mg/kg up to a maximum dose of 1.5 g, administered every 8 hours over 1 hour. The duration of therapy should be guided by the severity and site of infection and the patient's clinical and bacteriological progress.

Key safety warnings

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions are possible. Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ZERBAXA. If a severe allergic reaction occurs during treatment with ZERBAXA, the medicinal product should be discontinued and appropriate measures taken. There have been reports of neurotoxicity associated with cephalosporin treatment. Symptoms of neurotoxicity include encephalopathy, seizures and/or myoclonus. Risk factors for developing neurotoxicity with cephalosporin treatment include being elderly, renal impairment, central nervous system disorders and intravenous administration. Antibacterial-associated colitis and pseudomembranous colitis have been reported with ZERBAXA. These types of infection may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ZERBAXA. Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, ZERBAXA should be discontinued immediately and an alternative treatment should be considered.

Contraindications

ZERBAXA is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients listed in the product information, or in patients with known serious hypersensitivity to ceftolozane/tazobactam, or members of the cephalosporin class, or other members of the beta-lactam class.

PBS listing

No information regarding PBS listing, strength, item number, restriction type, or ex-manufacturer price is available in the provided source documents.

Regulatory history

ZERBAXA was approved on 2015-10-29 for the treatment of complicated intra-abdominal infections in combination with metronidazole and complicated urinary tract infections, including pyelonephritis, in adults suspected or proven to have infections caused by designated susceptible microorganisms. ZERBAXA ceftolozane sulfate/tazobactam sodium 1000 mg/500 mg powder for injection vial was first listed on the ARTG on 2015-11-04.