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