FDA approved Fetroja (cefiderocol) for Complicated UTIs and Hospital-Acquired PneumoniaFDA approved new antibiotic Fetroja for serious bacterial infections

FDA From the archive Source published November 14, 2019 Summary added July 7, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Fetroja for adults with cUTI or HABP/VABP caused by susceptible Gram-negative bacteria, with renal dose adjustments.

The FDA has approved Fetroja (cefiderocol), a cephalosporin antibacterial, for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The drug is indicated for infections caused by susceptible Gram-negative microorganisms such as Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa. Fetroja is administered intravenously and requires dose adjustments based on renal function. The approval provides a new option for clinicians treating serious Gram-negative infections, particularly in the context of rising antimicrobial resistance. The label emphasizes using Fetroja only when bacterial infection is proven or strongly suspected to preserve its effectiveness.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Cefiderocol is a cephalosporin antibacterial. Its mechanism of action involves inhibition of bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). It is designed to penetrate the outer membrane of Gram-negative bacteria via the bacterial iron transport system.

Indication & Patient Population

Fetroja is indicated in patients 18 years of age or older for: - Complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. - Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.

Dosing & Administration

The recommended dosage is 2 grams every 8 hours by IV infusion over 3 hours in patients with creatinine clearance (CLcr) 60 to 119 mL/min. Dose adjustments are required for CLcr less than 60 mL/min (including intermittent hemodialysis or CRRT) and for CLcr 120 mL/min or greater. For CLcr 30-59 mL/min: 1.5 grams every 8 hours; CLcr 15-29 mL/min: 1 gram every 8 hours; CLcr less than 15 mL/min (with or without HD): 0.75 grams every 12 hours. For CRRT, dosing depends on effluent flow rate. For CLcr ≥120 mL/min: 2 grams every 6 hours. Duration is 7 to 14 days.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Fetroja provides a treatment option for serious Gram-negative infections including cUTI and HABP/VABP in adults, particularly when caused by resistant pathogens. It should be used only when bacterial infection is proven or strongly suspected to reduce development of drug resistance.

The FDA has approved a new antibiotic called Fetroja (cefiderocol) for adults with serious bacterial infections. It treats complicated urinary tract infections, including kidney infections, and hospital-acquired or ventilator-associated pneumonia. These infections are often caused by bacteria that are resistant to many other antibiotics.

Fetroja is given through a vein (IV) and the dose may need to be adjusted for people with kidney problems. It is meant for patients 18 years and older. The approval is important because it offers a new tool against certain Gram-negative bacteria like E. coli and Pseudomonas aeruginosa, which can be very hard to treat.

This approval does not mean Fetroja is for everyone. The FDA emphasizes that the drug should only be used when a bacterial infection is confirmed or strongly suspected. Using antibiotics when they are not needed can make them less effective over time.

If you or a loved one has a serious infection, talk to your doctor. They can decide if Fetroja is a good option based on your specific situation. This new drug is a helpful addition, but it is not a first choice for all infections.

What this means for you:

Fetroja is a new IV antibiotic for serious infections; talk to your doctor if it might be right for you.

Study Details

Study typeFda approval

PublishedNov 2019

View Original Abstract ↓

1 INDICATIONS AND USAGE FETROJA is a cephalosporin antibacterial indicated in patients 18 years of age or older for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Complicated Urinary Tract Infections (cUTI), including Pyelonephritis ( 1.1 ) Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of FETROJA and other antibacterial drugs, FETROJA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.3 ) 1.1 Complicated Urinary Tract Infections (cUTIs), Including Pyelonephritis FETROJA ® is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , Pseudomonas aeruginosa , and Enterobacter cloacae complex [see Clinical Studies (14.1) ] . 1.2 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) FETROJA is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli , Enterobacter cloacae complex, Klebsiella pneumoniae , Pseudomonas aeruginosa , and Serratia marcescens [see Clinical Studies (14.2) ]. 1.3 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of FETROJA and other antibacterial drugs, FETROJA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

FDA approved Fetroja (cefiderocol) for Complicated UTIs and Hospital-Acquired PneumoniaFDA approved new antibiotic Fetroja for serious bacterial infections

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FDA approved Fetroja (cefiderocol) for Complicated UTIs and Hospital-Acquired PneumoniaFDA approved new antibiotic Fetroja for serious bacterial infections

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

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Clinical research that matters. Delivered to your inbox.

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