Zerbaxa
Authorised
This medicine is authorised for use in the European Union
ceftolozane / tazobactam
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Zerbaxa is an antibiotic used to treat adults and children with:
• complicated (difficult to treat) infections of tissues and organs within the belly (intra-abdominal infections);
• serious kidney infection (acute pyelonephritis);
• complicated infections of the urinary tract (structures that carry urine, such as the bladder).
It is also used to treat adults with hospital-acquired pneumonia (an infection of the lungs that is caught in the hospital), including ventilator-associated pneumonia (pneumonia in patients using a ventilator, a machine that helps a patient to breathe).
Zerbaxa contains the active substances ceftolozane and tazobactam.
Zerbaxa is available for infusion (drip) into a vein and can only be obtained with a prescription. It is given over 1 hour, every 8 hours. The dose and duration of treatment depend on the infection being treated and how the infection responds to the medicine. For children the dose and duration also depend on body weight. For more information about using Zerbaxa, see the package leaflet or contact your doctor or pharmacist.
The active substances in Zerbaxa, ceftolozane and tazobactam, work in different ways. Ceftolozane is a type of antibiotic called a cephalosporin, which belongs to the wider group of antibiotics called beta-lactams. It works by interfering with the production of molecules that bacteria need to build their protective cell walls. This causes weakness in the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
Tazobactam blocks the action of bacterial enzymes called beta-lactamases. These enzymes enable bacteria to break down beta-lactam antibiotics like ceftolozane, making the bacteria resistant to the antibiotic’s action. By blocking the action of these enzymes, tazobactam allows ceftolozane to act against bacteria that would otherwise be resistant to this antibiotic .
Zerbaxa has been shown to be at least as effective as other antibiotics in curing infections in three main studies.
One study involved 1,083 adults who mostly had kidney infection or in some cases a complicated urinary-tract infection. Zerbaxa successfully treated the infection in about 85% of the cases where it was given (288 of 340), compared with 75% (266 of 353) of those given another antibiotic called levofloxacin.
The second study involved 993 adults with complicated intra-abdominal infections. Zerbaxa was compared with another antibiotic, meropenem. Both medicines cured 94% of patients (353 out of 375 given Zerbaxa and 375 out of 399 given meropenem).
The third study involved 726 adults who were using a ventilator and who had either hospital-acquired pneumonia or ventilator-associated pneumonia. It found Zerbaxa to be at least as effective as meropenem: the infection had resolved in 54% of patients (197 out of 362) after 7 to 14 days of treatment with Zerbaxa compared with 53% of patients (194 out of 362) on meropenem. Three studies conducted in children younger than 18 years old showed that the way Zerbaxa is absorbed, modified and removed from the body in this age group and in adults is similar. Zerbaxa is therefore expected to show similar effectiveness.
The most common side effects with Zerbaxa (which may affect up to 1 in 10 people) are nausea (feeling sick), headache, constipation, diarrhoea,fever and increased liver enzyme levels. Side effects in children are similar to those in adults, with the following additional common side effects (which may affect up to 1 in 10 children): low levels of neutrophils (a type of white blood cell), increased appetite, and dysgeusia (taste disturbance). There is little data on the side effects of Zerbaxa in children younger than 3 months of age with complicated intra-abdominal infections. For the full list of side effects of Zerbaxa, see the package leaflet.
Zerbaxa must not be used in people who are hypersensitive (allergic) to Zerbaxa or any of its ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
The European Medicines Agency decided that Zerbaxa’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that Zerbaxa was effective at curing infections in the patients studied, but acknowledged that only a limited number of patients with complicated urinary tract infections had been included. The Agency also noted that tazobactam is not active against some classes of beta-lactamase that can cause problems of resistance. Regarding safety, side effects were considered to be typical and expected for an antibiotic of this kind.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zerbaxa have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Zerbaxa are continuously monitored. Side effects reported with Zerbaxa are carefully evaluated and any necessary action taken to protect patients.
Zerbaxa received a marketing authorisation valid throughout the EU on 18 September 2015.
This overview was last updated in 07-2022.
Product information
Latest procedure affecting product information:
N/0000263946
16/04/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Zerbaxa
- Active substance
- ceftolozane sulfate
- tazobactam sodium
- International non-proprietary name (INN) or common name
- ceftolozane
- tazobactam
- Therapeutic area (MeSH)
- Bacterial Infections
- Anatomical therapeutic chemical (ATC) code
- J01DI54
Pharmacotherapeutic group
Antibacterials for systemic useTherapeutic indication
Zerbaxa is indicated for the treatment of the following infections in adults:
- Complicated intra abdominal infections;
- Acute pyelonephritis;
- Complicated urinary tract infections;
- Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
News on Zerbaxa
Topics
This page was last updated on