Safety, Tolerability, and Population Pharmacokinetics of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

Author:

Arrieta Antonio C.1,Neely Michael2,Day J. Christopher3,Rheingold Susan R.4,Sue Paul K.5,Muller William J.6,Danziger-Isakov Lara A.78,Chu Julie9,Yildirim Inci10,McComsey Grace A.11,Frangoul Haydar A.1213,Chen Tempe K.14,Statler Victoria A.15,Steinbach William J.16,Yin Dwight E.3,Hamed Kamal17ORCID,Jones Mark E.17,Lademacher Christopher18,Desai Amit18,Micklus Kelley18,Phillips Desiree Leiva18,Kovanda Laura L.18ORCID,Walsh Thomas J.19

Affiliation:

1. Children’s Hospital of Orange County, Orange, California, USA

2. Children’s Hospital Los Angeles, University of Southern California, Los Angeles, California, USA

3. Children’s Mercy Kansas City, University of Missouri-Kansas City, Kansas City, Missouri, USA

4. Children’s Hospital of Philadelphia, Perelman School of Medicine, Philadelphia, Pennsylvania, USA

5. University of Texas Southwestern Medical Center, Dallas, Texas, USA

6. Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois, USA

7. Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA

8. University of Cincinnati, Cincinnati, Ohio, USA

9. Children’s Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, USA

10. Yale New Haven Children’s Hospital, Yale School of Medicine, New Haven, Connecticut, USA

11. University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA

12. The Children’s Hospital at TriStar Centennial, Nashville, Tennessee, USA

13. Sarah Cannon Research Institute, Nashville, Tennessee, USA

14. MemorialCare Miller Children’s and Women’s Hospital Long Beach, Long Beach, California, USA

15. Norton Children’s and University of Louisville School of Medicine, Louisville, Kentucky, USA

16. Duke University Medical Center, Durham, North Carolina, USA

17. Basilea Pharmaceutica International Ltd., Basel, Switzerland

18. Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA

19. Weill Cornell Medicine, Cornell University, New York, New York, USA

Abstract

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.

Funder

Basilea Pharmaceutica

Henry Schueler 41 & 9 Foundation

Astellas | Astellas Pharma Global Development

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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