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Cefiderocol

PHOTO

[Photo credit: businesswire.com]

KEY POINTS

  • Cefiderocol (Fetroja, formerly S-649266) is a siderophore cephalosporin and beta-lactam antibiotic that inhibits bacterial cell wall synthesis through binding to penicillin binding protein 3
    • Cefiderocol is able to chelate ferric ions and use bacterial iron transport systems, which has been called a “Trojan Horse” strategy and translates to higher concentrations in the periplasmic space of susceptible Gram negatives
    • Structural similarities to ceftazidime (C7-residue) and cefepime (C3-residue)
  • FDA approved November 14, 2019 for the treatment of complicated urinary tract infections in patients 18 years or older
  • FDA approved September 27, 2020 for treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.
  • Has a label warning for higher all-cause mortality versus other antibiotics in critically ill patients with multidrug-resistant Gram-negative bacterial infections
    • The cause of the higher mortality is not established
    • It was observed in patients treated for nosocomial pneumonia (i.e, HAP/VAP), bloodstream infections, and sepsis
  • Has activity against a variety of drug-resistant Gram negative organisms, including some carbapenem-resistant bacteria
    • Can have activity versus bacteria producing Ambler class A, B, C, or D beta-lactamases
      • Includes NDM (Ambler class B)
    • Can have activity versus some organisms harboring OmpK35/36 or OprD porin deletions
    • Has activity versus Acinetobacter baumannii, Pseudomonas aeruginosa, and Stenotrophomonas maltophilia
    • Is active against some E. coli isolates containing the mcr-1
    • Cross-resistance with other antimicrobials is yet to be identified
    • Has no clinically relevant in vitro activity against most Gram-positive bacteria and anaerobic bacteria
  • Intravenous only dosed as 2gm IV every 8 hours administered over 3 hours
    • Dose adjust for renal function, including creatinine clearance below 60 mL/min or above 120 mL/min
    • Comes in 1gm vials
  • Potential side effects include constipation, cough, diarrhea, headache, hypokalemia, increase AST/ALT, infusion site reactions, nausea or vomiting, rash, yeast infection
    • Seizures and other CNS effects have occurred
    • Not recommended for people with a known history of severe hypersensitivity to beta-lactams
  • Manufactured by Shionogi & Co., Ltd

RESOURCES

  • Cefiderocol (Fetroja) Package Insert
  • Shionogi Announces FDA Approval of FETROJA® (Cefiderocol) for the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
  • FDA Cefiderocol Approval Notice
  • Cefiderocol Susceptibility Information
  • Cefiderocol: a promising antibiotic against multidrug-resistant Gram-negative bacteria (2019)
  • Compassionate Use of Cefiderocol as Adjunctive Treatment of Native Aortic Valve Endocarditis Due to Extremely Drug-resistant Pseudomonas aeruginosa (2019)
  • Cefiderocol versus imipenem-cilastatin for the treatment of complicated urinary tract infections caused by Gram-negative uropathogens: a phase 2, randomised, double-blind, non-inferiority trial (2019)
  • Cefiderocol: A Siderophore Cephalosporin with Activity Against Carbapenem-Resistant and Multidrug-Resistant Gram-Negative Bacilli (2019)
  • Cefiderocol: a novel siderophore cephalosporin (2018)


 

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