Drug updated on 4/18/2024
| Dosage Form | Injection (intravenous; 1 g/vial) |
| Drug Class | Cephalosporin antibacterials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms.
- Indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP).
Summary
- Cefiderocol (Fetroja) is approved for the treatment of complicated urinary tract infections and hospital-acquired bacterial pneumonia in patients 18 years or older who have limited or no alternative treatment options. It has been associated with a lower mortality rate and fewer adverse drug reactions compared to other therapies, particularly in treating carbapenem-resistant Acinetobacter baumannii infections.
- Information was derived from seven studies that focused on comparing the safety and effectiveness of cefiderocol with other drugs for specific infections.
- One study highlighted potential challenges due to high resistance rates among certain carbapenem-resistant phenotypes, especially those involving New Delhi metallo-beta-lactamase-producing organisms, underscoring the importance of continuous surveillance.
- The investigation into off-label uses of cefiderocol showed its broad application beyond approved indications. In most instances, it displayed a positive safety profile when used as part of combination therapy against multi-drug resistant Pseudomonas aeruginosa and/or A. baumannii.
- A clinical study observed no significant difference in the efficacy of cefiderocol compared to other antibiotics in treating acute bacterial infections, suggesting its unique benefit may be in addressing antibiotic-resistant strains where alternatives are ineffective.
- Despite concerns about emerging resistance through beta-lactamases and porin mutations detailed in an analysis focusing on resistance mechanism prevalence, the overall findings suggest that cefiderocol provides promising safety profiles against multidrug-resistant Gram-negative bacteria where traditional treatments are unsuccessful.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Fetroja (cefiderocol) Prescribing Information. | 2021 | Shionogi Inc., Florham Park, NJ |