Open AccessSafety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Author(s) -
Antonio Arrieta,
Michael Neely,
J.P. Day,
Susan R. Rheingold,
Paul K. Sue,
William J. Muller,
Lara DanzigerIsakov,
Julie Chu,
İnci Yıldırım,
Grace A. McComsey,
Haydar Frangoul,
Tempe K. Chen,
Victoria A. Statler,
William J. Steinbach,
Dwight E Yin,
Kamal Hamed,
Mark Jones,
Christopher Lademacher,
Amit Desai,
Kelley Micklus,
Desiree Leiva Phillips,
Laura Kovanda,
Thomas J. Walsh
Publication year - 2021
Publication title -
antimicrobial agents and chemotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.07
H-Index - 259
eISSN - 1070-6283
pISSN - 0066-4804
DOI - 10.1128/aac.00290-21
Subject(s) - medicine , pharmacokinetics , tolerability , population , body surface area , nonmem , oral administration , adverse effect , pharmacology , environmental health
Isavuconazole, administered as the water-soluble prodrug isavuconazonium sulfate, is a new triazole agent used to treat invasive fungal infections. This phase 1 study evaluated the pharmacokinetics (PK), safety, and tolerability of isavuconazole in 46 immunocompromised pediatric patients, stratified by age (1 to <6 [intravenous (i.v.) only], 6 to <12, and 12 to <18 years), receiving 10 mg/kg body weight (maximum, 372 mg) isavuconazonium sulfate either i.v. or orally.