Safety and Pharmacokinetics of Repeat-Dose Micafungin in Young Infants

Abstract

Given the risk of central nervous system infection, relatively high weight‐based echinocandin dosages may be required for the successful treatment of invasive candidiasis and candidemia in young infants. This open‐label study assessed the safety and pharmacokinetics (PK) of micafungin in 13 young infants (>48 h and 0–24), 258.1 and 291.2 µg·h/ml; clearance at steady state adjusted for body weight, 0.45 and 0.57 ml/min/kg; maximum plasma concentration, 23.3 and 24.9 µ g/ml; and volume of distribution at steady state adjusted for body weight, 341.4 and 542.8 ml/kg. No deaths or discontinuations from treatment occurred. These data suggest that micafungin dosages of 7 and 10 mg/kg/day are well tolerated and provide exposure levels that have been shown (in animal models) to be adequate for central nervous system coverage. Clinical Pharmacology & Therapeutics (2010) 87 1, 93–99. doi:10.1038/clpt.2009.200