Cefiderocol

(Fetroja®)

Fetroja®

Drug updated on 10/29/2024

Dosage FormInjection (intravenous; 1 g/vial)
Drug ClassCephalosporin 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).

Latest News

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Summary
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  • This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
  • Cefiderocol-based regimens showed lower all-cause mortality (RR (relative risk)=0.71) and 30-day mortality (RR=0.64) compared to colistin-based regimens in patients with carbapenem-resistant Acinetobacter baumannii infections, particularly benefiting bloodstream infection (BSI) patients, while no significant difference was observed for ventilator-associated pneumonia (VAP) patients.
  • In the neonatal population, cefiderocol demonstrated a favorable efficacy and safety profile, indicating its potential for use in newborns, infants, and children.
  • Cefiderocol monotherapy resulted in lower 30-day mortality compared to combination regimens for carbapenem-resistant Acinetobacter baumannii infections, suggesting its effectiveness as a standalone treatment option.
  • There is a noted reduced susceptibility of cefiderocol in treating NDM-positive isolates, reflected by higher minimum inhibitory concentrations (MICs), indicating a need for caution in this subgroup.
  • In patients with carbapenem-resistant Acinetobacter baumannii infections, the incidence of acute kidney injury (AKI) did not increase in the cefiderocol-based group compared to colistin-based regimens.
  • Cefiderocol was associated with a lower rate of adverse drug reactions (ADRs) compared to the best available therapy (BAT), indicating a favorable safety profile in this population.

Product Monograph / Prescribing Information

Document TitleYearSource
Fetroja (cefiderocol) Prescribing Information.2024Shionogi Inc., Florham Park, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparison of cefiderocol and colistin-based regimens for the treatment of severe infections caused by carbapenem-resistant Acinetobacter baumannii: a systematic review with meta-analysis and trial sequential analysis2024BMC Infectious Diseases
Efficacy and safety of antibiotics targeting Gram-negative bacteria in nosocomial pneumonia: a systematic review and Bayesian network meta-analysis2024Annals of Intensive Care
Global mapping of antibiotic resistance rates among clinical isolates of Stenotrophomonas maltophilia: a systematic review and meta-analysis2024Annals of Clinical Microbiology and Antimicrobials
Cefiderocol either in monotherapy or combination versus best available therapy in the treatment of carbapenem-resistant Acinetobacter baumannii infections: A systematic review and meta-analysis2024The Journal of Infection
New Antimicrobials for the Treatment of Neonatal Sepsis Caused by Multi-Drug-Resistant Bacteria: A Systematic Review2023Antibiotics (Basel, Switzerland)
Comparative efficacy and safety of non-polymyxin antibiotics against nosocomial pneumonia, complicated intra-abdominal infection, or complicated urinary tract infection: A network meta-analysis of randomised clinical trials2023Journal of Global Antimicrobial Resistance
Stenotrophomonas maltophilia Infections: A Systematic Review and Meta-Analysis of Comparative Efficacy of Available Treatments, with Critical Assessment of Novel Therapeutic Options2023Antibiotics (Basel, Switzerland)
Empiric treatment of patients with sepsis and septic shock and place in therapy of cefiderocol: a systematic review and expert opinion statement2022Journal of Anesthesia, Analgesia and Critical Care
Cefiderocol for the Treatment of Multidrug-Resistant Gram-Negative Bacteria: A Systematic Review of Currently Available Evidence2022Frontiers in Pharmacology
Clinical efficacy and safety of cefiderocol in the treatment of acute bacterial infections: A systematic review and meta-analysis of randomised controlled trials2021 Journal of Global Antimicrobial Resistance

Clinical Practice Guidelines