Posaconazole delayed-release tablets in paediatric haematology-oncology patients.

Abstract

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