Drug updated on 4/18/2024
| Dosage Form | Injection (intravenous; 2 g ceftazidime [equivalent to 2.635 grams of ceftazidime pentahydrate/sodium carbonate powder] and 0.5 g avibactam [equivalent to 0.551 grams of avibactam sodium]) |
| Drug Class | Antibacterials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of complicated intra-abdominal infections (cIAI), used in combination with metronidazole, in adult and pediatric patients (at least 31 weeks gestational age), caused by designated susceptible Gram-negative microorganisms.
- Indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adult and pediatric patients (at least 31 weeks gestational age), caused by designated susceptible Gram-negative microorganisms.
- Indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), in adult and pediatric patients (at least 31 weeks gestational age), caused by designated susceptible Gram-negative microorganisms.
Summary
- Ceftazidime-avibactam (Avycaz) is indicated for the treatment of complicated intra-abdominal infections, urinary tract infections, and hospital-acquired bacterial pneumonia. It has demonstrated superior clinical efficacy in treating Carbapenem-resistant Enterobacteriaceae (CRE) infections compared to polymyxin-based therapy.
- The analysis was based on 13 systematic reviews/meta-analyses that provided a detailed comparison of Avycaz's safety and effectiveness against other antibiotics.
- For complicated intra-abdominal infections, Avycaz showed comparable clinical efficacy and safety to carbapenems, presenting it as a viable alternative without significant differences in adverse events.
- In real-world use against Gram-negative organisms such as CRE and multidrug-resistant Pseudomonas aeruginosa, Avycaz proved effective with relatively rare resistance development occurrences.
- Renal dosing adjustments of Avycaz were associated with a higher mortality risk in patients with carbapenem-resistant Gram-negative infections, indicating caution is needed in its application for renal-impaired individuals.
- No significant differences were found between ceftolozane-tazobactam and Avycaz in treating complicated intra-abdominal infections, suggesting similar effectiveness among these drugs but more evidence is needed for specific infection types or pathogens before determining the most effective treatment approach.
- The overall evaluation through various clinical trials suggests that Avycaz shows comparable or even superior effectiveness across different settings including cUTIs, cIAIs, and CRE caused by MDR pathogens while maintaining similar adverse event profiles compared to other antibiotics like carbapenems.
- Avycaz's efficacy seems consistent across adult populations with varying conditions; however, dosage adjustments are crucial, especially for vulnerable groups like those with renal impairments, which may impact outcomes, thus emphasizing personalized dosing considerations.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Avycaz (ceftazidime and avibactam) Prescribing Information. | 2024 | Allergan USA Inc., Madison, NJ |