Posaconazole delayed-release tablets in paediatric haematology-oncology patients

Mycoses. 2020 Jun;63(6):604-609. doi: 10.1111/myc.13084. Epub 2020 Apr 15.

Abstract

Background: To date, there are few studies that describe pharmacokinetics, safety and efficacy of posaconazole delayed-release tablet (DRT) formulation in the paediatric population.

Objectives: We evaluated retrospectively posaconazole plasma concentrations and safety of posaconazole DRT in paediatric haematology-oncology patients.

Patients and methods: 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 50 kg (range 22-83 kg). Twenty-one patients received posaconazole 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 μg/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 μg/mL 100% by first week, 80% by second week and 33.4% by fourth week.

Conclusions: Posaconazole DRT is feasible in paediatric patients capable to swallow tablets. Specific pharmacokinetic studies are needed.

Keywords: antifungal agents; antifungal target; deep fungal infection; paediatric malignancy; posaconazole; posaconazole delayed-release tablet (DRT).

MeSH terms

  • Administration, Oral
  • Adolescent
  • Antifungal Agents / pharmacokinetics*
  • Antifungal Agents / therapeutic use
  • Child
  • Child, Preschool
  • Delayed-Action Preparations / pharmacokinetics
  • Delayed-Action Preparations / therapeutic use
  • Female
  • Hematologic Neoplasms / microbiology*
  • Humans
  • Male
  • Mycoses / drug therapy*
  • Mycoses / prevention & control*
  • Retrospective Studies
  • Tablets / administration & dosage
  • Triazoles / pharmacokinetics*
  • Triazoles / therapeutic use

Substances

  • Antifungal Agents
  • Delayed-Action Preparations
  • Tablets
  • Triazoles
  • posaconazole