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Posaconazole delayed-release tablets in paediatric haematology-oncology patients
Margherita Mauro1, Antonella Colombini2, Katia Perruccio3
1Pediatric Hematology Oncology, Department of Mother and Child, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
Insights
Posaconazole delayed-release tablets (DRT) show feasibility in pediatric patients who can swallow them. Further pharmacokinetic studies are needed to confirm efficacy and safety in this population.
Area of Science:
- Pharmacology
- Pediatric Oncology
Background:
- Limited data exists on posaconazole delayed-release tablet (DRT) pharmacokinetics, safety, and efficacy in pediatric patients.
- Posaconazole is a crucial antifungal agent for immunocompromised individuals.
Purpose of the Study:
- To retrospectively evaluate posaconazole plasma concentrations and safety of the DRT formulation in pediatric hematology-oncology patients.
- To assess the feasibility of posaconazole DRT in a pediatric cohort.
Main Methods:
- Retrospective analysis of 28 pediatric hematology-oncology patients (median age 15 years) receiving posaconazole DRT.
- Patients received posaconazole DRT for prophylaxis (n=21) or therapy (n=7).
- Dosing and trough levels were monitored.
Main Results:
- For prophylaxis, 80% achieved target trough levels (≥0.7 μg/mL) by week 1, with doses ranging from 2.2-22.2 mg/kg/day.
- For therapy, 100% achieved target trough levels (≥1 μg/mL) by week 1, with doses ranging from 3.3-4.5 mg/kg/day.
- Posaconazole DRT was found to be feasible in children able to swallow tablets.
Conclusions:
- Posaconazole DRT is a feasible administration route for pediatric patients capable of swallowing tablets.
- The study highlights the need for dedicated pharmacokinetic studies to further elucidate posaconazole DRT behavior in pediatric populations.
- Feasibility suggests potential for wider use in pediatric antifungal management.
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.
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