Pharmacokinetics of Subcutaneous and Intravenous Ceftriaxone in an Older Population: The PhASAge Study

Pharmacokinetics of Subcutaneous and Intravenous Ceftriaxone in an Older Population: The PhASAge Study. Roubaud-Baudron, C., Fauchon, H., Stanke-Labesque, F., Paccalin, M., Breilh, D., Grégoire, N., Forestier, E., Ferry, T., Gavazzi, G., Goutelle, S., the Infectiology, GInGer), G. I. (., Albaret, G., Hyernart, C., Thiel, E., Meriglier, E., Bronnimann, D., Blanc, P., Clabe, E., Domergue, H., Chaussade, H., Pavese, P., Pierre, I., Arlaud, C., Froidure, M., Le Marechal, M., Drevet, S., Allan, L., Bioteau, C., Pouderoux, C., Chabert, P., Gledel, C., Gaujard, S., De La Gastine, B., Leperre, A., Chauleur, Y., Lanfranchi, G., Schir, S., Brunet, T., Gueremy, A., Bosch, A., Destrem, A., Isnard, M., Baclet, N., F, E, Lanoix, J., Caraux-Paz, P., G, G, Putot, A., R, B C, & Weil, N. Open Forum Infectious Diseases, 12(6):ofaf313, May, 2025.

Paper doi abstract bibtex

Abstract Background Ceftriaxone is frequently administered subcutaneously in France, especially in older patients, although this practice is currently off-label. This work aims to describe the pharmacokinetics (PK) and pharmacodynamics (PD) and tolerance of ceftriaxone administered by intravenous and subcutaneous routes in older patients. Methods Patients aged ≥65 years receiving intravenous or subcutaneous ceftriaxone 1 g every 24 hours were included. Steady-state plasma concentrations of ceftriaxone were measured. Based on intravenous and subcutaneous ceftriaxone concentrations and 24-hour area under the concentration-time curve (AUC), a population PK model was developed for probability of target attainment (PTA) analysis. Local and systemic adverse events (AEs) were collected. Results Data from 47 patients (24 in subcutaneous and 23 in intravenous groups) were analyzed. No between-group difference was observed in demographic and biological characteristics, ceftriaxone trough concentrations, or AUC. Bioavailability of subcutaneous ceftriaxone was estimated at 99% by population modeling. The PTA associated with subcutaneous administration were similar to or slightly better than that of the intravenous route. A dosing regimen of 1 or 2 g every 24 hours was associated with acceptable PTA and a low risk of overexposure in patients with normal or moderately altered renal function. Tolerance was assessed on 149 infusions (67 intravenous and 82 subcutaneous). One local AE (1.5%) was reported in the intravenous group versus 11 local AEs (mainly edema) in the subcutaneous group (13%), all transient and nonsevere. Conclusions Subcutaneous administration of ceftriaxone was associated with PK/PD and dosage requirements comparable to those of intravenous administration, supporting the use of subcutaneous ceftriaxone in older patients.

@article{roubaud-baudron_pharmacokinetics_2025,
	title = {Pharmacokinetics of {Subcutaneous} and {Intravenous} {Ceftriaxone} in an {Older} {Population}: {The} {PhASAge} {Study}},
	volume = {12},
	copyright = {https://creativecommons.org/licenses/by-nc-nd/4.0/},
	issn = {2328-8957},
	shorttitle = {Pharmacokinetics of {Subcutaneous} and {Intravenous} {Ceftriaxone} in an {Older} {Population}},
	url = {https://academic.oup.com/ofid/article/doi/10.1093/ofid/ofaf313/8153422},
	doi = {10.1093/ofid/ofaf313},
	abstract = {Abstract 
             
              Background 
              Ceftriaxone is frequently administered subcutaneously in France, especially in older patients, although this practice is currently off-label. This work aims to describe the pharmacokinetics (PK) and pharmacodynamics (PD) and tolerance of ceftriaxone administered by intravenous and subcutaneous routes in older patients. 
             
             
              Methods 
              Patients aged ≥65 years receiving intravenous or subcutaneous ceftriaxone 1 g every 24 hours were included. Steady-state plasma concentrations of ceftriaxone were measured. Based on intravenous and subcutaneous ceftriaxone concentrations and 24-hour area under the concentration-time curve (AUC), a population PK model was developed for probability of target attainment (PTA) analysis. Local and systemic adverse events (AEs) were collected. 
             
             
              Results 
              Data from 47 patients (24 in subcutaneous and 23 in intravenous groups) were analyzed. No between-group difference was observed in demographic and biological characteristics, ceftriaxone trough concentrations, or AUC. Bioavailability of subcutaneous ceftriaxone was estimated at 99\% by population modeling. The PTA associated with subcutaneous administration were similar to or slightly better than that of the intravenous route. A dosing regimen of 1 or 2 g every 24 hours was associated with acceptable PTA and a low risk of overexposure in patients with normal or moderately altered renal function. Tolerance was assessed on 149 infusions (67 intravenous and 82 subcutaneous). One local AE (1.5\%) was reported in the intravenous group versus 11 local AEs (mainly edema) in the subcutaneous group (13\%), all transient and nonsevere. 
             
             
              Conclusions 
              Subcutaneous administration of ceftriaxone was associated with PK/PD and dosage requirements comparable to those of intravenous administration, supporting the use of subcutaneous ceftriaxone in older patients.},
	language = {en},
	number = {6},
	urldate = {2025-08-26},
	journal = {Open Forum Infectious Diseases},
	author = {Roubaud-Baudron, Claire and Fauchon, Héloïse and Stanke-Labesque, Françoise and Paccalin, Marc and Breilh, Dominique and Grégoire, Nicolas and Forestier, Emmanuel and Ferry, Tristan and Gavazzi, Gaëtan and Goutelle, Sylvain and {the Infectiology and Geriatrics InterGroup (SPILF-SFGG GInGer)} and Albaret, Guillaume and Hyernart, Caroline and Thiel, Elise and Meriglier, Etienne and Bronnimann, Didier and Blanc, Peggy and Clabe, Emilie and Domergue, Hélène and Chaussade, Hélène and Pavese, Patricia and Pierre, Isabelle and Arlaud, Cyprien and Froidure, Marie and Le Marechal, Marion and Drevet, Sabine and Allan, Laure and Bioteau, Catherine and Pouderoux, Cécile and Chabert, Paul and Gledel, Claire and Gaujard, Sylvain and De La Gastine, Blandine and Leperre, Armelle and Chauleur, Youri and Lanfranchi, Giuseppina and Schir, Sophie and Brunet, Thomas and Gueremy, Alexandre and Bosch, Alexie and Destrem, Anne-Laure and Isnard, Margaux and Baclet, Nicolas and F, E and Lanoix, Jean-Philippe and Caraux-Paz, Pauline and G, G and Putot, Alain and R, B C and Weil, Nathalie},
	month = may,
	year = {2025},
	pages = {ofaf313},
}

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