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Clinical experience with SUBA-itraconazole at a tertiary paediatric hospital

Joanne Abbotsford1, David A Foley1, Zoy Goff1

  • 1Department of Infectious Diseases, Perth Children's Hospital, Nedlands, Western Australia, Australia.

The Journal of Antimicrobial Chemotherapy
|September 15, 2020
PubMed
Abstract

Insights

The new SUper BioAvailability itraconazole (SUBA-itraconazole) formulation shows promise for pediatric fungal infections. Most children achieved therapeutic drug levels, demonstrating good tolerability and efficacy, especially for allergic bronchopulmonary aspergillosis.

Area of Science:

  • Pediatric Infectious Diseases
  • Pharmacology and Therapeutics
  • Mycology

Background:

  • Itraconazole is a key antifungal for pediatric conditions like allergic bronchopulmonary aspergillosis (ABPA) and sporotrichosis.
  • Existing oral itraconazole formulations often fail to achieve therapeutic drug levels in children.
  • Paediatric data for the novel SUper BioAvailability itraconazole (SUBA-itraconazole) formulation are limited.

Purpose of the Study:

  • To evaluate the safety and efficacy of SUBA-itraconazole in pediatric patients.
  • To assess the attainment of therapeutic drug levels with SUBA-itraconazole in children.
  • To determine the clinical response in children treated with SUBA-itraconazole.

Main Methods:

  • A single-centre retrospective cohort study included pediatric patients prescribed SUBA-itraconazole.
  • Dosing followed recommendations: 5 mg/kg twice daily (max 400 mg/day) for treatment, 2.5 mg/kg/day for prophylaxis.
  • Data collected on patient demographics, indications, dosage, duration, serum drug levels, and clinical response.

Main Results:

  • Nineteen pediatric patients (median age 12 years) received SUBA-itraconazole.
  • Nearly 60% (10/17) achieved therapeutic itraconazole levels, with 7 achieving levels after the initial dose.
  • 81% of ABPA patients showed a therapeutic IgE response; the formulation was well-tolerated with no adverse effect-related discontinuations.

Conclusions:

  • SUBA-itraconazole is well-tolerated in children.
  • The formulation facilitates rapid attainment of therapeutic drug levels in most pediatric patients.
  • SUBA-itraconazole may offer a superior option for pediatric fungal infections requiring itraconazole.

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