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Pharmacokinetics of Posaconazole Oral Suspension in Children Dosed According to Body Surface Area

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Background:

Antifungal prophylaxis remains challenging in immunocompromised children as no clear consensus has yet been reached about which drug to be used. Posaconazole has a broad spectrum of activity, a favorable safety profile and excellent prophylactic activity in adults. However, a lack of pharmacokinetic studies in pediatric patients hampers routine implementation. This study investigates the pharmacokinetics of a newly introduced posaconazole dosing regimen based on the body surface area in pediatric hematologic patients.

Methods:

In this prospective pharmacokinetic study, 8 blood samples were taken during 1 dosing interval at steady state in children aged 13 years or younger with hematologic malignancy, who were treated prophylactically with posaconazole oral suspension at a dose of 120 mg/m2 3 times daily. Posaconazole plasma concentrations were determined using high-performance liquid chromatography fluorescence detection.

Results:

One hundred twelve samples were taken from 14 patients with a mean age of 6.7 ± 2.8 years. A median posaconazole daily dose of 100.0 mg (77.3–100.0) 3 times daily (tid), corresponding to a median of 117.9 mg/m2 (112.2–120.4) tid, resulted in mean trough posaconazole plasma concentrations of 0.85 ± 0.56 mg/L. Pharmacokinetic analysis revealed a clearance of 0.8 L/(h kg) (0.5–1.4). No invasive fungal infections or adverse events were encountered during treatment.

Conclusions:

Posaconazole is a promising antifungal agent to be used prophylactically in hematologic patients aged 13 years or younger. Administering posaconazole oral suspension in a dosage of 120 mg/m2 tid results in adequate posaconazole plasma exposure, without significant adverse events.
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Keywords: body surface area; dosing regimen; pediatrics; posaconazole oral suspension; prophylaxis

Document Type: Research Article

Publication date: February 1, 2016

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