Individualization of fosfomycin dosing based on therapeutic drug monitoring (TDM) of plasma concentrations could reduce drug-related adverse events and improve clinical outcome in complex clinical conditions. Quantification of fosfomycin in plasma samples was performed by a rapid ultraperformance liquid chromatography mass spectrometry method. Sample preparation involved protein precipitation with [13C3]-fosfomycin benzylamine salt as internal standard. The calibration curve ranged from 2 to 800 mg/L. Within- and between-day precision and accuracy, sensitivity, selectivity, dilution integrity, recovery were investigated and the results met the acceptance criteria. In patients, multiple drug dosing (every 6 or 8 hours) or in continuous administration were adopted, resulting in a large interpatient variability in drug concentrations (from 7.4 mg/L and 644.6 mg/L; CV: 91.1%). In critical care patient setting TDM can represent an important tool to identify the best fosfomycin dosing in single patients, taking into consideration clinical characteristics, infection sites and susceptibility of the treated pathogens.

Fosfomycin therapeutic drug monitoring in real-life: development and validation of a LC-MS/MS method on plasma samples / S. Baldelli, M. Cerea, D. Mangioni, L. Alagna, A. Muscatello, A. Bandera, D. Cattaneo. - In: JOURNAL OF CHEMOTHERAPY. - ISSN 1120-009X. - (2021), pp. 1-10. [Epub ahead of print] [10.1080/1120009X.2021.1963617]

Fosfomycin therapeutic drug monitoring in real-life: development and validation of a LC-MS/MS method on plasma samples

S. Baldelli
Primo
;
M. Cerea
Secondo
;
D. Mangioni;A. Bandera
Penultimo
;
D. Cattaneo
Ultimo
2021

Abstract

Individualization of fosfomycin dosing based on therapeutic drug monitoring (TDM) of plasma concentrations could reduce drug-related adverse events and improve clinical outcome in complex clinical conditions. Quantification of fosfomycin in plasma samples was performed by a rapid ultraperformance liquid chromatography mass spectrometry method. Sample preparation involved protein precipitation with [13C3]-fosfomycin benzylamine salt as internal standard. The calibration curve ranged from 2 to 800 mg/L. Within- and between-day precision and accuracy, sensitivity, selectivity, dilution integrity, recovery were investigated and the results met the acceptance criteria. In patients, multiple drug dosing (every 6 or 8 hours) or in continuous administration were adopted, resulting in a large interpatient variability in drug concentrations (from 7.4 mg/L and 644.6 mg/L; CV: 91.1%). In critical care patient setting TDM can represent an important tool to identify the best fosfomycin dosing in single patients, taking into consideration clinical characteristics, infection sites and susceptibility of the treated pathogens.
bioanalytical method validation; Fosfomycin; fosfomycin concentration; LC-MS/MS; TDM; Therapeutic drug monitoring; UPLC;
Settore MED/17 - Malattie Infettive
Settore MED/04 - Patologia Generale
Settore CHIM/09 - Farmaceutico Tecnologico Applicativo
19-ago-2021
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/868508
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