What is Zavicefta - Ceftazidima - Avibactam used for?
Zavicefta is an antibiotic used in adults to treat the following infections:
- complicated infections (difficult to treat) of tissues and organs of the belly (intra-abdominal infections);
- complicated infections (difficult to treat) of the urinary tract (structures responsible for transporting urine), including pyelonephritis (kidney infection);
- infections of the lungs contracted in the hospital (hospital-acquired pneumonia), including pneumonia associated with mechanical ventilation (pneumonia contracted by a ventilator, or a device that helps the patient to breathe);
- infections caused by Gram-negative bacteria (a type of bacteria) in case of failure of the other treatments.
Zavicefta contains the active ingredients ceftazidime and avibactam.
How is Zavicefta - Ceftazidime - Avibactam used?
Zavicefta is available as a powder to be reconstituted to obtain a solution for infusion into a vein (drip). The infusion is given within two hours, three times a day. Generally, the treatment lasts 5 to 14 days, depending on the type of infection.
In patients with severely reduced kidney function it is necessary to reduce and / or decrease the frequency of dose administration.
Zavicefta can only be obtained with a prescription and prescribers must take into consideration the official guidelines for the use of antibiotics.
For more information, see the package leaflet.
How does Zavicefta - Ceftazidima - Avibactam work?
The active ingredients of Zavicefta are ceftazidime and avibactam. Ceftazidime is an antibiotic called cephalosporin, belonging to the broader 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 bacteria weakens and tends to disintegrate, eventually causing the death of the bacteria.
Avibactam blocks the action of bacterial enzymes called beta-lactamases. These are enzymes that allow bacteria to break down beta-lactam antibiotics like ceftazidime, making them resistant to antibiotic action. By blocking the action of these enzymes, avibactam allows ceftazidime to act against these bacteria that would otherwise be resistant.
What benefit has Zavicefta - Ceftazidime - Avibactam shown during the studies?
The benefits of Zavicefta have been highlighted in four main studies. In two studies, the effects of the combination of Zavicefta and metronidazole (another antibiotic) were compared with those of the antibiotic meropenem, in 1, 490 patients with complicated intra-abdominal infection. Both studies showed that Zavicefta in combination with metronidazole was as effective in treating infection as it was meropenem. In the first study, 92% of patients (376 out of 410) in one of the study groups treated with Zavicefta and metronidazole achieved healing, compared with 93% of patients (385 out of 416) treated with meropenem. In the second study, 94% of patients (166 of 177) treated with Zavicefta and metronidazole achieved healing, compared with 94% of patients (173 of 184) treated with meropenem.
The third study examined 332 patients with complicated intra-abdominal or urinary tract infections caused by Gram-negative bacteria resistant to ceftazidime (bacteria that were not killed by ceftazidime). Zavicefta monotherapy (for urinary tract infections) or in combination with metronidazole (for intra-abdominal infections) produced results similar to several alternative antibiotics in the treatment of infection: 91% of patients (140 of 154) obtained healing after Zavicefta treatment compared to 91% of patients (135 out of 148) after treatment with the best alternative antibiotic. Furthermore, the bacteria that caused the disease were eliminated in 82% (126 out of 154) of patients after Zavicefta treatment compared to 63% of patients (94 out of 148) after treatment with the best alternative antibiotic. Due to the nature of this study, the evidence of Zavicefta's benefits is not as strong as those of other studies; however, these results, combined with those of other studies, support the activity of Zavicefta.
In the fourth study, 1, 020 patients with complicated urinary tract infections (including pyelonephritis) caused by Gram-negative bacteria, were treated with Zavicefta or with the antibiotic doripenem. One of the main measures of effectiveness was based on eliminating the bacteria that had caused the disease. Zavicefta has shown efficacy at least equal to doripenem: a response was obtained in 77% of patients (304 out of 393) treated with Zavicefta compared to 71% of patients (296 out of 417) treated with doripenem.
What are the risks associated with Zavicefta - Ceftazidima - Avibactam?
The most common side effects of Zavicefta (which may affect more than 5 people in 100) are nausea, diarrhea and a positive Coombs test (a sign of the development of antibodies against red blood cells). For the full list of all side effects reported with Zavicefta, see the package leaflet. Zavicefta should not be used in patients who are hypersensitive (allergic) to the active substances of Zavicefta or to any of its ingredients, nor to subjects who are hypersensitive to other cephalosporin antibiotics or who have had a serious allergic reaction to another antibiotic in the past. .
Why has Zavicefta - Ceftazidime - Avibactam been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zavicefta's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the Zavicefta studies show that the medicine is effective in treating complicated intra-abdominal and urinary tract infections. A Zavicefta study conducted on patients with hospital-acquired pneumonia is still ongoing. However, the CHMP considered that the data already available support the efficacy of Zavicefta in the treatment of hospital-acquired pneumonia and infections caused by gram-negative aerobic organisms in adult patients in the event of failure of other therapies. Regarding the safety profile, the undesirable effects are the same as those for ceftazidime and beta-lactamase inhibitors.
What measures are being taken to ensure the safe and effective use of Zavicefta - Ceftazidime - Avibactam?
The company that makes Zavicefta is conducting a study that compares the efficacy and safety of Zavicefta with meropenem (another antibiotic), in the treatment of hospital-acquired pneumonia.
Recommendations and precautions to be taken by health professionals and patients regarding the safety and effective use of Zavicefta have also been added to the summary of product characteristics and the package leaflet.
Other information about Zavicefta - Ceftazidima - Avibactam
For the full EPAR of Zavicefta, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Zavicefta therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
