Zerbaxa - Ceftolozano / Tazobactam

What is Zerbaxa - Ceftolozano / Tazobactam used for?

Zerbaxa is an antibiotic indicated for the treatment of adults with complicated bacterial infections (difficult to heal) borne by:

abdominal tissues and organs (intra-abdominal infections);
kidneys (pyelonephritis);
urinary tract (structures that carry urine, including the bladder).

The medicine contains the active ingredients ceftolozane and tazobactam.

How is Zerbaxa - Ceftolozano / Tazobactam used?

Zerbaxa is available as a powder to be made up into a solution for infusion (drip into a vein) and can only be obtained with a prescription. One dose containing 1 g of ceftolozane and 0.5 g of tazobactam is given as an infusion lasting one hour every eight hours for 4-14 days, depending on the infection treated and the response to the medicine. The medicine should be prescribed taking into account official guidelines on the use of antibiotics. In patients with impaired renal function it may be necessary to reduce the dose.

How does Zerbaxa - Ceftolozano / Tazobactam work?

The active substance in Zerbaxa, ceftolozane, is a type of antibiotic called cephalosporin, which belongs to the larger group of "beta-lactams". It works by interfering with the production of some molecules that bacteria need to build cell walls responsible for their protection. In this way the cell wall of the bacterium weakens and tends to disintegrate, causing the death of the bacterium.

Zerbaxa also contains the active ingredient tazobactam, a substance that blocks the action of certain enzymes called betalactamases. These are enzymes that allow bacteria to break down beta-lactams like ceftolozane, making them resistant to antibiotic action. By blocking the action of these enzymes, tazobactam allows ceftolozane to act against these bacteria that would otherwise be resistant.

What benefit has Zerbaxa - Ceftolozano / Tazobactam shown during the studies?

In two main studies Zerbaxa has been shown to be at least as effective as other antibiotics in treating infections.

A study was carried out on 1, 083 patients mainly suffering from kidney infection or, in some cases, from a complicated urinary tract infection. Zerbaxa therapy eliminated infection in about 85% of patients treated with the medicine (288 out of 340) compared to 75% (266 out of 353) of subjects treated with another antibiotic (levofloxacin).

The second study was conducted on 993 patients with complicated intra-abdominal infections. Zerbaxa has been compared with another antibiotic, meropenem. Both drugs led to the recovery of approximately 94% of patients (353 of 375 treated with Zerbaxa and 375 of 399 treated with meropenem).

What is the risk associated with Zerbaxa - Ceftolozano / Tazobactam?

The most common side effects with Zerbaxa (which may affect up to 1 in 10 people) are nausea, headache, constipation, diarrhea and fever, usually mild or moderate. For the full list of all side effects reported with Zerbaxa, see the package leaflet.

Zerbaxa must not be used in people who are hypersensitive (allergic) to Zerbaxa or any of its ingredients or to people who are hypersensitive to other cephalosporin antibiotics or who have had a severe allergic reaction to another antibiotic.

Why has Zerbaxa - Ceftolozano / Tazobactam been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zerbaxa's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the effectiveness of Zerbaxa in treating infections had been demonstrated, but noted that only a limited number of patients with complicated urinary tract infections were included in the studies. The committee also found that tazobactam is notoriously ineffective against some classes of beta-lactamases that can cause resistance problems. As for safety, the undesirable effects were considered typical and in line with the expectations for an antibiotic of this type.

What measures are being taken to ensure the safe and effective use of Zerbaxa - Ceftolozano / Tazobactam?

A risk management plan has been developed to ensure that Zerbaxa is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zerbaxa, including the appropriate precautions to be followed by healthcare professionals and patients.