Posaconazole delayed-release tablets in pediatric hematology-oncology patients.

BACKGROUND: To date, there are few studies that describe pharmacokinetics, safety, and efficacy of posaconazole delayed release tablet (DRT) formulation in the pediatric population. OBJECTIVES: We evaluated retrospectively posaconazole plasma concentrations and safety of posaconazole DRT in pediatric hematology-oncology patients. PATIENTS AND METHODS: Posaconazole DRT was assessed in 28 hematological pediatric patients with a median age 15 of years (range 5-18) and a median body weight of 50 kg (range 22-83 kg). Twenty-one patients received posoconazole DRT as prophylaxis and 7 patients as therapy. RESULTS: As prophylaxis, the median daily dose was 5.5 mg/kg/day (range 2.2-22.2) with posaconazole trough level >/= 0.7 mug/mL in 80% by first week, 62.5% by second week, and 87.5% by fourth week. As therapy, the median daily dose was 4 mg/kg/day (range 3.3-4.5) with trough level >/= 1 mug/mL 100% by first week, 80% by second week and 33.4% by fourth week. CONCLUSIONS: Posaconazole DRT is feasible in pediatric patients capable to swallow tablets. Specific pharmacokinetic studies are needed.