Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Antonio Arrieta, Michael Neely, J. Christopher Day, Susan R. Rheingold, Paul K. Sue, William J. Muller, Lara Danziger‐Isakov, Julie Chu, İnci Yıldırım, Grace A. McComsey, Haydar Frangoul, Tempe K. Chen, Victoria A. Statler, William J. Steinbach, Dwight E. Yin, Kamal Hamed, Mark E. Jones, Christopher Lademacher, Amit Desai, Kelley Micklus, Desiree Leiva Phillips, Laura Kovanda, Thomas J. Walsh
Abstract
range, 60 to 233 μg · h/ml) was estimated; this target range was derived from plasma drug exposures in adults receiving the recommended clinical dose. Predicted plasma drug exposures were within the target range for >80% and >76% of simulated pediatric patients following i.v. or oral administration, respectively. Intravenous and oral administration of isavuconazonium sulfate at the studied dosage of 10 mg/kg was well tolerated and resulted in exposure in pediatric patients similar to that in adults. (This study has been registered at ClinicalTrials.gov under identifier NCT03241550).