Fetroja® (cefiderocol) has been made available by Shionogi for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. The treatment is indicated for patients aged ≥18 years with limited or no alternative treatment options.

Cefiderocol is a novel cephalosporin antibacterial that penetrates the outer cell membrane of Gram-negative pathogens by acting as a siderophore. Approval of Fetroja was based on data from an active-controlled noninferiority trial in which the drug was compared with imipenem-cilastatin in patients with cUTI. Results of the study showed that Fetroja was noninferior to the comparator.

Fetroja is administered via intravenous infusion; dosage adjustments are recommended for patients with creatinine clearance (CrCl) less than 60mL/min, as well as for those with CrCl >120mL/min. The recommended duration of treatment is 7 to 14 days; duration of therapy should be guided by infection severity and the patient’s clinical status.  

The most frequently occurring adverse reactions associated with Fetroja include diarrhea, infusion site reactions, constipation, rash, candidiasis, cough, elevations in liver tests, headache, hypokalemia, nausea and vomiting. 

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“We are proud to make Fetroja available for patients and their infectious disease care teams,” said Nate McCutcheon, Chief Commercial Officer, Shionogi Inc. “Currently, Fetroja is the only available antibiotic which provides in vitro coverage against all Gram-negative pathogens considered top priority by the WHO.” 

Fetroja is supplied as lyophilized powder for reconstitution in single-dose vials containing 1g of cefiderocol.

For more information visit fetroja.com.