Pharmacokinetics and safety of multiple intravenous doses of daptomycin in a Taiwanese adult population.

ABSTRACT

BACKGROUND: The pharmacokinetics (PK) and safety of daptomycin have not yet been studied in an adult Taiwanese population. METHODS: A total of 13 healthy adult Taiwanese subjects (7 males and 6 females) were enrolled to receive a 5-day course of multiple intravenous daptomycin infusions at a dose of 4 mg/kg every 24 h. Both single-dose and steady-state serum PK were assessed. RESULTS: PK evaluation showed no relevant accumulation of daptomycin based on the steady-state PK, which could be predicted from the single-dose PK. No gender effect on daptomycin, for either single- or multiple-dose PK, was observed. About 60% of the infused daptomycin was eliminated by the renal system in an unchanged form. Protein binding of daptomycin was about 93.92%. The PK parameters in healthy Taiwanese subjects were similar to those reported in healthy Caucasian subjects. No serious adverse events (AE) or deaths occurred during the study. The most frequently reported AE was leukopenia (3/19, 15.8%), followed by amblyopia (2/19, 10.5%). These AEs were considered to be mild-to-moderate in severity and resolved spontaneously. CONCLUSION: This study demonstrated similarities between Taiwanese and Caucasian healthy subjects in the PK profiles of daptomycin, and thus the dosage regimen used in Caucasian subjects could be applied to Taiwanese.