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Safety and pharmacokinetics of repeat-dose micafungin in young infants

D K Benjamin1, P B Smith, A Arrieta

  • 1Department of Pediatrics and Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA. danny.benjamin@duke.edu

Clinical Pharmacology and Therapeutics
|November 6, 2009
PubMed

Insights

High-dose micafungin (7 and 10 mg/kg/day) is safe and effective for treating invasive candidiasis and candidemia in young infants, achieving adequate drug exposure for central nervous system coverage.

Area of Science:

  • Pediatric Infectious Diseases
  • Pharmacokinetics and Drug Metabolism
  • Neonatal Critical Care

Background:

  • Invasive candidiasis and candidemia pose significant risks to young infants, potentially requiring higher echinocandin doses for effective treatment due to central nervous system infection risks.
  • Assessing the safety and pharmacokinetics (PK) of micafungin in this vulnerable population is crucial for optimizing treatment strategies.

Purpose of the Study:

  • To evaluate the safety and pharmacokinetic profile of two weight-based micafungin dosages (7 and 10 mg/kg/day) in young infants with suspected or confirmed invasive candidiasis or candidemia.
  • To determine if these dosages provide adequate drug exposure for potential central nervous system (CNS) penetration.

Main Methods:

  • An open-label study involving 13 young infants (age >48 hours and <120 days) with suspected candidemia or invasive candidiasis.
  • Infants received either 7 mg/kg/day (body weight ≥1000 g) or 10 mg/kg/day (body weight <1000 g) for at least 4-5 days.
  • Pharmacokinetic parameters including AUC(0-24), weight-adjusted clearance, Cmax, and weight-adjusted volume of distribution were analyzed.

Main Results:

  • No deaths or treatment discontinuations were reported, indicating good tolerability of both micafungin dosages.
  • Median pharmacokinetic values showed comparable drug exposure across both dosage groups, with AUC(0-24) of 258.1 and 291.2 µg*h/mL for 7 and 10 mg/kg/day, respectively.
  • Weight-adjusted clearance and volume of distribution varied between groups, reflecting the different weight categories, while Cmax was similar (23.3 vs 24.9 µg/mL).

Conclusions:

  • Micafungin dosages of 7 and 10 mg/kg/day are well-tolerated in young infants with invasive candidiasis or candidemia.
  • These dosages achieve drug exposure levels previously demonstrated in animal models to be adequate for achieving central nervous system coverage.
  • The findings support the use of these weight-based micafungin regimens for treating invasive fungal infections in neonates and young infants.

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