Cefiderocol

FETROJA is an antibacterial drug [see Microbiology (12.4) ] .

• 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) ] .ICD-10: J18.9, N39.0

• FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of FETROJA [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol and other beta-lactam antibacterial drugs or other components of FETROJA.contraindicated

Administer 2 grams of FETROJA for injection every 8 hours by intravenous (IV) infusion over 3 hours in patients with creatinine clearance (CLcr) 60 to 119 mL/min. ( 2.1 ) Dose adjustments are required for patients with CLcr less than 60 mL/min, (including patients receiving intermittent hemodialysis (HD) or continuous renal replacement therapy (CRRT)), and for patients with CLcr 120 mL/min or greater. ( 2.2 ) See full prescribing information for instructions on preparation of FETROJA doses. ( 2.3 ) See full prescribing information for drug compatibilities. ( 2.4 ) 2.1 Recommended Dosage The recommended dosage of FETROJA is 2 grams administered every 8 hours by intravenous (IV) infusion over 3 hours in adults with a creatinine clearance (CLcr) of 60 to 119 mL/min. Dosage adjustment of FETROJA is recommended for patients with CLcr less than 60 mL/min, including patients receiving intermittent hemodialysis (HD) or continuous renal replacement therapy (CRRT), and for patients with CLcr 120 mL/min or greater [see Dosage and Administration (2.2) ]. The recommended duration of treatment with FETROJA is 7 to 14 days. The duration of therapy should be guided by the patient's clinical status. 2.2 Dosage Adjustments in Patients with CLcr Less Than 60 mL/min (Including Patients Undergoing Intermittent HD or CRRT), and CLcr 120 mL/min or Greater Dosage Adjustments in Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Dosage adjustment of FETROJA is recommended in patients with CLcr less than 60 mL/min (Table 1).

Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections: An increase in all-cause mortality was observed in FETROJA-treated patients compared to those treated with best available therapy (BAT). Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP. ( 5.1 ) Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed with FETROJA. Cross-hypersensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue FETROJA. ( 5.2 ) Clostridioides difficile -associated Diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including FETROJA. Evaluate if diarrhea occurs. ( 5.3 ) Seizures and Other Central Nervous System (CNS) Adverse Reactions: CNS adverse reactions such as seizures have been reported with FETROJA. If focal tremors, myoclonus, or seizures occur, evaluate patients to determine whether FETROJA should be discontinued. ( 5.4 ) 5.1 Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections An increase in all-cause mortality was observed in patients treated with FETROJA as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595).

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section: Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated Diarrhea (CDAD) [see Warnings and Precautions (5.3) ] Seizures and Other Central Nervous System Adverse Reactions [see Warnings and Precautions (5.4) ] cUTI: The most frequently occurring adverse reactions in greater than or equal to 2% of cUTI patients treated with FETROJA were diarrhea, infusion site reactions, constipation, rash, candidiasis, cough, elevations in liver tests, headache, hypokalemia, nausea, and vomiting. ( 6.1 ) HABP/VABP: The most frequently occurring adverse reactions in greater than or equal to 4% of HABP/VABP patients treated with FETROJA were elevations in liver tests, hypokalemia, diarrhea, hypomagnesemia, and atrial fibrillation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Inc. at 1-800-849-9707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary There are no available data on FETROJA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available data from published prospective cohort studies, case series, and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . Developmental toxicity studies with cefiderocol administered during organogenesis to rats and mice showed no evidence of embryo-fetal toxicity, including drug-induced fetal malformations, at doses providing exposure levels 0.9 times (rats) or 1.3 times (mice) higher than the average observed in patients receiving the maximum recommended daily dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Cefiderocol exposures (C max and daily AUC) in cUTI patients, HABP/VABP patients, and healthy volunteers are summarized in Table 6. Cefiderocol C max and AUC increased proportionally with dose.

There is no information on clinical signs and symptoms associated with an overdose of FETROJA. Patients who receive doses greater than the recommended dose regimen and have unexpected adverse reactions possibly associated with FETROJA should be carefully observed and given supportive treatment, and discontinuation or interruption of treatment should be considered. Approximately 60% of cefiderocol is removed by a 3- to 4-hour hemodialysis session [see Clinical Pharmacology (12.3) ].

• Nov 14, 2019NDANDA209445Shionogi

1. 1Death7123%
2. 2Drug Resistance309.9%
3. 3Treatment Failure278.9%
4. 4Off Label Use247.9%
5. 5Acute Kidney Injury206.6%
6. 6Pathogen Resistance175.6%
7. 7Multiple Organ Dysfunction Syndrome144.6%
8. 8Hepatic Cytolysis134.3%
9. 9Infection134.3%
10. 10Condition Aggravated113.6%
11. 11Septic Shock113.6%
12. 12Cholestasis103.3%
13. 13Encephalopathy103.3%
14. 14No Adverse Event103.3%
15. 15Sepsis93.0%

Recent PubMed references pinned to Cefiderocol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Genomic analysis reveals multi-level resistance network linking oxidative stress pathway mutations to cefiderocol resistance and clonal evolution in Klebsiella pneumoniae from the United Arab Emirates.
  Frontiers in cellular and infection microbiology · 2026 · Daoud L, Collyns T, Ghazawi A, et al.
  PMID 42221590DOI 10.3389/fcimb.2026.1820198
• Characterization of KPC-160, a novel Ω-loop-deleted KPC variant on a dual-copy plasmid that confers cefiderocol resistance.
  Antimicrobial agents and chemotherapy · 2026 · Liu Y, Hong H, Huang Q, et al.
  PMID 42089618DOI 10.1128/aac.01358-25
• Combinatorial effects of a novel SHV-248 variant, NDM-5, and ompK35 deficiency drive high-level cefiderocol resistance in Klebsiella pneumoniae.
  Microbiology spectrum · 2026 · Zhao C, Liu Y, Hong H, et al.
  PMID 42059619DOI 10.1128/spectrum.00026-26
• Fatal clonal outbreak of KPC-2-producing Enterobacter roggenkampii in Pediatric patients: Cefiderocol resistance and a novel IncU plasmid.
  International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2026 · da Silva Nascimento L, Rodrigues DCS, Sued-Karam BR, et al.
  PMID 42035983DOI 10.1016/j.ijid.2026.108727
• Outstanding presence of New Delhi metallo-beta-lactamase in carbapenem-resistant Enterobacterales and exceptionally potent in vitro activity of cefiderocol and aztreonam-avibactam emphasises their immediate access in India.
  Transactions of the Royal Society of Tropical Medicine and Hygiene · 2026 · Sengupta M, Ammy K, Banik I, et al.
  PMID 41869915DOI 10.1093/trstmh/trag022
• Real-world use of cefiderocol as monotherapy or combination therapy for the treatment of Gram-negative bacterial infections: the multicentre retrospective CEFI-BAC study.
  International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2026 · Augello M, Di Bartolomeo F, Varisco B, et al.
  PMID 41360217DOI 10.1016/j.ijid.2025.108305
• In vitro activity of cefiderocol and sulbactam-durlobactam against carbapenem-resistant Acinetobacter baumannii clinical isolates collected between 2019 and 2024.
  Infectious diseases (London, England) · 2026 · Palavecino EL, Kilic A
  PMID 41330880DOI 10.1080/23744235.2025.2597465
• Cefiderocol versus standard therapy for hospital-acquired and health-care-associated Gram-negative bacterial bloodstream infection (the GAME CHANGER trial): an open-label, parallel-group, randomised trial.
  The Lancet. Infectious diseases · 2026 · Paterson DL, Sulaiman H, Liu PY, et al.
  PMID 41067237DOI 10.1016/S1473-3099(25)00469-4

The 10 most recently updated of 27 ClinicalTrials.gov registrations naming Cefiderocol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Impact of Siderophore Genes on Cefiderocol Susceptibility in Carbapenem Resistant Hypervirulent Klebsiella Pneumoniae
  Not yet recruiting · Observational · 100 enrolled · Sohag University
  NCT07475429updated 2026-03-24
• Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
  Recruiting · Phase 4 · Interventional · 12 enrolled · University of Tennessee
  NCT07465432updated 2026-03-12
• A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
  Completed · Phase 2 · Interventional · 30 enrolled · Shionogi
  NCT06086626updated 2026-03-02
• A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
  Completed · Phase 2 · Interventional · 53 enrolled · Shionogi
  NCT04335539updated 2026-02-27
• Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
  Not yet recruiting · Phase 2 · Interventional · 120 enrolled · BioVersys AG
  NCT07431307updated 2026-02-24
• A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
  Completed · Phase 1 · Interventional · 60 enrolled · Qpex Biopharma, Inc.
  NCT06547554updated 2025-11-28
• A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment
  Recruiting · Phase 1 · Interventional · 40 enrolled · Qpex Biopharma, Inc.
  NCT07104162updated 2025-11-25
• Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation
  Active not recruiting · Observational · 5,000 enrolled · National Institutes of Health Clinical Center (CC)
  NCT07226557updated 2025-11-10
• Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales
  Not yet recruiting · Observational · 100 enrolled · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  NCT07160569updated 2025-09-08
• Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
  Recruiting · Phase 4 · Interventional · 734 enrolled · Rambam Health Care Campus
  NCT05922124updated 2025-08-01

Frequently asked questions

How does Cefiderocol work?

FETROJA is an antibacterial drug [see Microbiology (12.4) ] .

What is Cefiderocol used for?

According to FDA labeling, Cefiderocol carries indications including: 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) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cefiderocol?

Cefiderocol is classified as Other cephalosporins and penems, Cephalosporin Antibacterial, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.

What are the brand names for Cefiderocol?

Cefiderocol is marketed under brand names including Fetroja.

What are the contraindications for Cefiderocol?

Cefiderocol labeling lists contraindications including: FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of FETROJA [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol and other beta-lactam antibacterial drugs or other components of FETROJA.. Always consult the full prescribing information and a clinician.