Fetroja FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 28, 2020.
FDA Approved: Yes (First approved November 14, 2019)
Brand name: Fetroja
Generic name: cefiderocol
Dosage form: Injection
Company: Shionogi Inc.
Treatment for: Complicated Urinary Tract Infections; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia
Fetroja (cefiderocol) is a siderophore cephalosporin indicated for the treatment of complicated urinary tract infections (cUTI), hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-negative microorganisms.
- Cefiderocol is a novel antibiotic that works by acting like a Trojan horse. The drug acts as a siderophore, binding to ferric iron to penetrate the outer cell membrane of Gram-negative pathogens taking advantage of the bacteria’s need for iron to survive.
- Fetroja is administered every 8 hours via intravenous (IV) infusion.
- Patients receiving Fetroja should be aware of the possibility of serious allergic reactions, potentially serious diarrhea (Clostridium difficile-associated diarrhea), and central nervous system (CNS) adverse reactions including seizures.
- Common adverse reactions in patients treated for cUTI include diarrhea, infusion site reactions, constipation, rash, candidiasis, cough, elevations in liver tests, headache, hypokalemia, nausea, and vomiting.
- Common adverse reactions in patients treated for HABP/VABP include elevations in liver tests, hypokalemia, diarrhea, hypomagnesemia, and atrial fibrillation.
Development Timeline for Fetroja
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