Safety and pharmacokinetics of repeat-dose micafungin in young infants

Due to the risk of central nervous system infection, relatively high weight-based echinocandin dosages may be required for successful treatment of invasive candidiasis and candidemia in young infants. This open-label study assessed safety and pharmacokinetics of micafungin in 13 young infants (> 48 hours of age and < 120 days of life) with suspected candidemia or invasive candidiasis. Infants weighing ≥ 1,000 g and < 1,000 g received 7 and 10 mg/kg/day, respectively, for a minimum of 4 to 5 days. Mean baseline weight and gestational age were 2101 g and 688 g, and 30 weeks and 25 weeks, in the 7 and 10 mg/kg/day groups, respectively. Median pharmacokinetic values for the 7 and 10 mg/kg/day groups, respectively, were: AUC(0–24), 258.1 and 291.2 μg•h/ml; Cl(ss/wt,) 0.45 and 0.57 ml/min/kg; C(max,) 23.3 and 24.9 μg/ml; and Vd(ss/wt,) 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 were well tolerated and provided exposure that was demonstrated in animal model to be adequate for central nervous system coverage

Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates

BACKGROUND: Candida infections are common and often fatal in infants and neonates. Anidulafungin has excellent activity against Candida sp, but unknown pharmacokinetics and safety in infants and neonates. OBJECTIVE: Determine the pharmacokinetics and safety of anidulafungin in infants and neonates at risk for invasive candidiasis. METHODS: Intravenous anidulafungin (1.5 mg/kg/day maintenance dose) was administered to 15 infants and neonates over 3 to 5 days. Plasma samples were obtained following the first and third to fifth dosesPharmacokinetic parameters were determined by non-compartmental analysis. Safety was assessed using National Cancer Institute common toxicity criteria. RESULTS: Drug exposure was similar between neonates and infants: median area under the curve (range) was 75 (30–109) μg*h/mL and 98 (55–278) μg*h/mL (P=0.12), respectively. No drug-related serious adverse events were observed. CONCLUSIONS: Neonates and infants receiving 1.5 mg/kg/day have similar anidulafungin exposures compared to children receiving similar weight-based dosing and adult patients receiving 100 mg/day