Safety and pharmacokinetics of repeat-dose micafungin in young infants.

Journal Article (Journal Article;Multicenter Study)

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 <120 days of life) with suspected candidemia or invasive candidiasis. Infants of body weight > or =1,000 and <1,000 g received 7 and 10 mg/kg/day, respectively, for a minimum of 4-5 days. In the 7-mg/kg/day group, the mean baseline weight and gestational age were 2,101 g and 30 weeks, respectively; in the 10-mg/kg/day group, they were 688 g and 25 weeks, respectively. The median pharmacokinetic values for the 7- and 10-mg/kg/day groups, respectively, were as follows: area under the concentration-time curve from 0 to 24 h (AUC(0-24)), 258.1 and 291.2 microg x 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 micro 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.

Full Text

Duke Authors

Cited Authors

  • Benjamin, DK; Smith, PB; Arrieta, A; Castro, L; Sánchez, PJ; Kaufman, D; Arnold, LJ; Kovanda, LL; Sawamoto, T; Buell, DN; Hope, WW; Walsh, TJ

Published Date

  • January 2010

Published In

Volume / Issue

  • 87 / 1

Start / End Page

  • 93 - 99

PubMed ID

  • 19890251

Pubmed Central ID

  • PMC2824925

Electronic International Standard Serial Number (EISSN)

  • 1532-6535

Digital Object Identifier (DOI)

  • 10.1038/clpt.2009.200


  • eng

Conference Location

  • United States