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Pharmacokinetic and Safety Profiles of Repeated-dose Prophylactic Micafungin in Children and Adolescents Undergoing Hematopoietic Stem Cell Transplantation

Albano, Edythe MD; Azie, Nkechi MD; Roy, Mike PhD; Townsend, Robert PhD; Arrieta, Antonio MD

Journal of Pediatric Hematology/Oncology:
doi: 10.1097/MPH.0000000000000218
Online Articles: Clinical and Laboratory Observations
Abstract

Micafungin is a potent echinocandin antifungal that can be used for both prophylaxis and treatment of Candida infections. This open-label study assessed the pharmacokinetics and safety profile of prophylactic micafungin in children and adolescents (aged 4 mo to 16 y) undergoing hematopoietic stem cell transplantation. Patients received once-daily doses of either 1 or 1.5 mg/kg micafungin, based on their body weight, for 10 to 14 days. In total, 40 patients received micafungin. Area under the plasma micafungin concentration–time curve was highest in patients aged 6 to 11 years in the 1.5 mg/kg treatment group. Peak plasma micafungin concentration displayed no age-related differences, but was higher in the 1.5 mg/kg versus the 1 mg/kg group. Clearance at steady state by weight and volume of distribution by weight were considerably higher in patients aged 4 months to 5 years. Results from this study show that age and body weight affect micafungin pharmacokinetics in pediatric patients undergoing hematopoietic stem cell transplantation.

Author Information

*Department of Pediatrics, School of Medicine and Children’s Hospital Colorado, University of Colorado, Aurora, CO

Astellas Pharma Global Development, Northbrook, IL

Division of Infectious Disease, Children’s Hospital of Orange County, Orange, CA

E.A. was an investigator on this study, was involved in analysis and interpretation of data, and provided direction for and intellectual content of manuscript drafts through meetings and correspondence. N.A. was involved in acquisition of data, participated in evaluation and assessment of data, and provided direction for and intellectual content of manuscript drafts through meetings and correspondence. M.R. was involved in the concept and design of the study, acquisition, evaluation and assessment of data, and provided direction for and intellectual content of manuscript drafts through meetings and correspondence. R.T. was involved in analysis and interpretation of data, and provided direction for and intellectual content of manuscript drafts through meetings and correspondence. A.A. was an investigator on this study, was involved in the concept and design of the study, evaluation and assessment of data, and provided direction for and intellectual content of manuscript drafts through meetings and correspondence.

N.A. and R.T. are employees of Astellas. M.R. was previously an employee of Astellas. A.A. has received grants from Astellas, Pfizer, and Merck, and consultancy fees from Astellas and Pfizer. E.A. declares no conflict of interest.

Reprints: Edythe Albano, MD, Department of Pediatrics, School of Medicine and Children’s Hospital Colorado, University of Colorado, 13123 East 16th Avenue, Aurora, CO 80045 (e-mail: edie.albano@gmail.com).

Received August 2, 2013

Accepted June 21, 2014

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.