Current and future use of isavuconazole in children and adolescents.
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Invasive fungal infections (IFI) present significant challenges in newborn, children and adolescents, particularly in immunocompromised patients, such as those with some primary immunodeficiencies or hematologic malignancies, and those who undergo hematopoietic stem cell transplantation. Isavuconazole (ISA), a broad-spectrum triazole antifungal, has emerged as an effective alternative for treating IFI in adults, especially those caused by Aspergillus and Mucorales. Recent approvals by the Food and Drug Administration (2023) and the European Medicines Agency (2024) have extended the use of ISA to paediatric populations, offering an important addition to the current treatment options. Two clinical trials have assessed ISA in paediatric patients, showing it is generally well tolerated, with an acceptable safety profile. While adverse events are primarily gastrointestinal and hepatic, they are less frequent than those associated with voriconazole or liposomal amphotericin B. According to pharmacokinetic studies, drug clearance is faster in children, particularly in those under 35kg; thus, doses require careful modification. ISA may represent a crucial advancement in the treatment of paediatric IFIs, but therapeutic drug monitoring remains essential due to variability in drug concentrations.