ANTIBIÓTICO HOSPITALARIO
Cefiderocol
Ficha de consulta para farmacia hospitalaria: indicaciones, preparación, dilución, estabilidad y compatibilidad de cefiderocol, con la fuente oficial de cada dato.
- Proteger de la luz
- Conservar refrigerado
También conocido como: Fetroja
Presentación
Fetroja: 1 g, polvo liofilizado, vial unidosis — Shionogi Inc.
| Producto de referencia | Titular | Vía | Fuente |
|---|---|---|---|
| Fetroja | Shionogi Inc. | Intravenous | FDA (DailyMed) |
¿Para qué sirve cefiderocol? Indicaciones autorizadas
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…
FDA (DailyMed) · Fetroja · Indications and usage · texto original en inglésLeer la sección completa
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.
Contraindicaciones de cefiderocol
4 CONTRAINDICATIONS 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. ( 4 )
FDA (DailyMed) · Fetroja · Contraindications · texto original en inglés
Ajuste en insuficiencia renal
Parámetro que cita la fuente: CrCl (aclaramiento de creatinina) · Diálisis / TRRC
2 DOSAGE AND ADMINISTRATION 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.
FDA (DailyMed) · Fetroja · Dosage and administration · texto original en inglés
( 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) ].
FDA (DailyMed) · Fetroja · Dosage and administration · texto original en inglés
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).
FDA (DailyMed) · Fetroja · Dosage and administration · texto original en inglés
For patients with fluctuating renal function, monitor CLcr and adjust dosage accordingly. Table 1 Recommended Dosage of FETROJA for Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Estimated Creatinine Clearance (CLcr) CLcr = creatinine clearance estimated by Cockcroft-Gault equation. Dose Frequency Infusion Time HD = hemodialysis. CLcr 30 to 59 mL/min 1.5 grams Every 8 hours 3…
FDA (DailyMed) · Fetroja · Dosage and administration · texto original en inglésLeer la sección completa
For patients with fluctuating renal function, monitor CLcr and adjust dosage accordingly. Table 1 Recommended Dosage of FETROJA for Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Estimated Creatinine Clearance (CLcr) CLcr = creatinine clearance estimated by Cockcroft-Gault equation. Dose Frequency Infusion Time HD = hemodialysis. CLcr 30 to 59 mL/min 1.5 grams Every 8 hours 3 hours CLcr 15 to 29 mL/min 1 gram Every 8 hours 3 hours CLcr less than 15 mL/min, with or without intermittent HD Cefiderocol is removed by HD; administer FETROJA immediately after HD for patients receiving intermittent HD. 0.75 grams Every 12 hours 3 hours Dosage Adjustments in Patients Receiving CRRT For patients receiving CRRT, including continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF), the dosage of FETROJA should be based on the effluent flow rate in CRRT (see Table 2 ).
Dosing regimens may need to be tailored based on residual renal function and patient's clinical status [see Use in Specific Populations (8.6) ] . Table 2 Recommended Dosage of FETROJA for Patients Receiving CRRT Effluent Flow Rate Ultrafiltrate flow rate for CVVH, dialysis flow rate for CVVHD, ultrafiltrate flow rate plus dialysis flow rate for CVVHDF. Recommended Dosage of FETROJA CRRT = continuous renal replacement…
FDA (DailyMed) · Fetroja · Dosage and administration · texto original en inglésLeer la sección completa
Dosing regimens may need to be tailored based on residual renal function and patient's clinical status [see Use in Specific Populations (8.6) ] . Table 2 Recommended Dosage of FETROJA for Patients Receiving CRRT Effluent Flow Rate Ultrafiltrate flow rate for CVVH, dialysis flow rate for CVVHD, ultrafiltrate flow rate plus dialysis flow rate for CVVHDF. Recommended Dosage of FETROJA CRRT = continuous renal replacement therapy. 2 L/hr or less 1.5 grams every 12 hours 2.1 to 3 L/hr 2 grams every 12 hours 3.1 to 4 L/hr 1.5 grams every 8 hours 4.1 L/hr or greater 2 grams every 8 hours Dosage Adjustments in Patients with CLcr 120 mL/min or Greater For patients with CLcr greater than or equal to 120 mL/min, FETROJA 2 grams administered every 6 hours by IV infusion over 3 hours is recommended [see Use in Specific Populations (8.6) ] . 2.3 Preparation of FETROJA Solution for Administration FETROJA is supplied as a sterile, lyophilized powder that must be reconstituted and subsequently diluted using aseptic technique prior to intravenous infusion.
Table 1 Recommended Dosage of FETROJA for Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Estimated Creatinine Clearance (CLcr) CLcr = creatinine clearance estimated by Cockcroft-Gault equation. | Dose | Frequency | Infusion Time HD = hemodialysis. CLcr 30 to 59 mL/min | 1.5 grams | Every 8 hours | 3 hours CLcr 15 to 29 mL/min | 1 gram | Every 8 hours | 3 hours CLcr less than 15…
FDA (DailyMed) · Fetroja · Dosage and administration table · texto original en inglésLeer la sección completa
Table 1 Recommended Dosage of FETROJA for Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Estimated Creatinine Clearance (CLcr) CLcr = creatinine clearance estimated by Cockcroft-Gault equation. | Dose | Frequency | Infusion Time
HD = hemodialysis.
CLcr 30 to 59 mL/min | 1.5 grams | Every 8 hours | 3 hours
CLcr 15 to 29 mL/min | 1 gram | Every 8 hours | 3 hours
CLcr less than 15 mL/min, with or without intermittent HD Cefiderocol is removed by HD; administer FETROJA immediately after HD for patients receiving intermittent HD. | 0.75 grams | Every 12 hours | 3 hours
Table 2 Recommended Dosage of FETROJA for Patients Receiving CRRT Effluent Flow Rate Ultrafiltrate flow rate for CVVH, dialysis flow rate for CVVHD, ultrafiltrate flow rate plus dialysis flow rate for CVVHDF. | Recommended Dosage of FETROJA
CRRT = continuous renal replacement therapy.
2 L/hr or less | 1.5 grams every 12 hours
2.1 to 3 L/hr | 2 grams every 12 hours
3.1 to 4 L/hr | 1.5 grams every 8 hours
4.1 L/hr or greater | 2 grams every 8 hours
Table 3 Preparation of FETROJA Doses FETROJA Dose | Number of 1-gram FETROJA Vials to be Reconstituted | Volume to Withdraw from Reconstituted Vial(s) | Total Volume of FETROJA Reconstituted Solution for Further Dilution into a 100 mL Infusion Bag
2 grams | 2 vials | 11.2 mL (entire contents) of each vial | 22.4 mL
1.5 grams | 2 vials | 11.2 mL (entire contents) of first vial AND 5.6 mL from second vial | 16.8 mL
1 gram | 1 vial | 11.2 mL (entire contents) | 11.2 mL
0.75 gram | 1 vial | 8.4 mL | 8.4 mL
In comparison, in the meropenem-treated patients for each of these subgroups, they were 10.3%, 17.8%, and 9.1%, respectively. cUTI and HABP/VABP FETROJA is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
FDA (DailyMed) · Fetroja · Use in specific populations · texto original en inglés
Dosage adjustment for elderly patients should be based on renal function [see Dosage and Administration (2.2) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] . 8.6 Renal Impairment Patients with CLcr 60 to 89 mL/min No dosage adjustment of FETROJA is recommended in patients with CLcr 60 to 89 mL/min. Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Dose adjustment is required in patients with CLcr less than 60 mL/min, and in patients who are receiving HD.
FDA (DailyMed) · Fetroja · Use in specific populations · texto original en inglés
Monitor renal function regularly and adjust the dosage of FETROJA accordingly as renal function may change during the course of therapy.
FDA (DailyMed) · Fetroja · Use in specific populations · texto original en inglés
While on CRRT, a patient's residual renal function may change. Improvements or reductions in residual renal function may warrant a change in FETROJA dosage. Patients with CLcr 120 mL/min or Greater CLcr 120 mL/min or greater may be seen in seriously ill patients, who are receiving intravenous fluid resuscitation. Dosage adjustment of FETROJA is required in patients with CLcr 120 mL/min or greater [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ]. Monitor renal function regularly and adjust the dosage of FETROJA accordingly as renal function may change during the course of therapy. 8.7 Hepatic Impairment The effects of hepatic impairment on the pharmacokinetics of cefiderocol have not been evaluated.
FDA (DailyMed) · Fetroja · Use in specific populations · texto original en inglés
Ajuste en insuficiencia hepática
Monitor renal function regularly and adjust the dosage of FETROJA accordingly as renal function may change during the course of therapy. 8.7 Hepatic Impairment The effects of hepatic impairment on the pharmacokinetics of cefiderocol have not been evaluated. Hepatic impairment is not expected to alter the elimination of cefiderocol as hepatic metabolism/excretion represents a minor pathway of elimination for cefiderocol. Dosage adjustments are not necessary in patients with impaired hepatic function.
FDA (DailyMed) · Fetroja · Use in specific populations · texto original en inglés
Reconstitución de cefiderocol
10 mL de NaCl 0.9% o glucosa 5%; volumen resultante aproximadamente 11.2 mL. Diluir antes de administrar.
Dilución de cefiderocol
Transferir el volumen prescrito a una bolsa de 100 mL de NaCl 0.9% o glucosa 5%.
Administración de cefiderocol
Perfusión IV de 3 horas.
Estabilidad y periodo de validez
| Condición | Tiempo | Nota |
|---|---|---|
| Vial reconstituido a temperatura ambiente | 1 h | Límite de la etiqueta del producto; no sustituye el límite microbiológico del protocolo local. No sumar plazos de conservación. |
| Bolsa diluida a temperatura ambiente | 6 h | Límite de la etiqueta del producto; no sustituye el límite microbiológico del protocolo local. No sumar plazos de conservación. |
| Bolsa diluida a 2–8 °C, protegida de luz | 24 h | Límite de la etiqueta del producto; no sustituye el límite microbiológico del protocolo local. No sumar plazos de conservación. |
Compatibilidad de cefiderocol
Compatible con
- NaCl 0.9% y glucosa 5% como diluyentes; no implica compatibilidad entre medicamentos.
Conservación y protección de la luz
2–8 °C; conservar en la caja.
Proteger vial de la luz. Proteger la bolsa cuando se conserve refrigerada; no se infiere necesidad de línea opaca.
¿Se puede triturar?
No aplica: inyectable.
Advertencias
- Verificar ajuste renal en la etiqueta y protocolo institucional.
- No congelar la solución diluida.
- Tras refrigeración, completar la infusión dentro de 6 h a temperatura ambiente.
Fuentes
- FDA (DailyMed) · FetrojaShionogi Inc. · 1 g, polvo liofilizado, vial unidosis · versión 2026-02-24
Diagnósticos relacionados
Diagnósticos que la ficha técnica de cefiderocol menciona en sus indicaciones. Cada uno abre su definición y los demás medicamentos indicados.
Identificación
- SNOMED CT (VTM)
- 258521000140106
- RxNorm
- 2265702
Información de consulta profesional extraída de las fichas técnicas y etiquetas oficiales citadas. Las condiciones de preparación, estabilidad y administración dependen del producto concreto: verifica el documento del producto que utilizas. No sustituye el criterio clínico ni la valoración del paciente.