Vol.56 No.2 March 2008
Efficacy, safety and pharmacokinetics of micafungin in pediatric patients with deep mycoses
1)Division of Infectious Disease, Kitasato Institute for Life Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
2)Department of Pediatrics, Toho University Omori Medical Center
(Present: Children's Center for Health and Development, Saiseikai Yokohamashi Tobu Hospital)
3)Department of Pediatrics, Sekishinkai Sayama Hospital
4)Division of Pediatric Oncology, Department of Strategic Medicine, National Center for Child Medical Health and Development
(Present: Visiting Researcher, Division of Pediatric Oncology, National Center for Child Medical Health and Development)
5)Department of Pediatrics, Meitetsu Hospital
6)Department of Pharmacy, Keio University Hospital
Abstract
We studied the efficacy, safety and pharmacokinetics of micafungin(MCFG) in pediatric patients with deep mycoses, and conducted a multicenter, non-blinded, uncontrolled study to estimate the pediatric dosage and administration schedule. The results in the 20 cases that were enrolled in this study are as follows:
1. In terms of the overall clinical effect, the study drug was "effective" in 10/14 cases (71.4%) overall, 7/11 cases (63.6%) of candidiasis, and all of the 3 cases of aspergillosis.
2. The percent incidence of adverse drug reactions (accompanying symptoms) was 5% (1/20 cases), and an anaphylactoid reaction occurred in 1 case only. The percent incidence of adverse drug reactions (abnormal laboratory test value changes) was 25.0% (5/20 cases), and the most frequently seen events were liver function disorders, such as increased AST, increased ALT, increased ALP, increased γ-GTP, etc. None of these events were serious, and it was not necessary to discontinue or decrease the dose of the study drug in any of the patients. The adverse drug reactions were not dose-dependent either.
3. Both Cmax and Cmin showed linearity in the dose range of 1.0 to 6.0 mg/kg/day based on the results of the pharmacokinetics study. The half-life was approximately 13 hours and was generally constant, irrespective of the dose level and age.
Based on the abovementioned results, the efficacy, safety and in vivo pharmacokinetics of micafungin in pediatric patients, including school children, infants, and nursing infants, at doses (1.0 to 6.0 mg/kg/day) calculated with body weight adjustment from the approved adult dosage (50 to 300 mg/day), did not differ widely from those in adult patients, and the drug is expected to become a useful drug for pediatric patients with deep mycoses.
Key word
micafungin, clinical trial, pediatric patient, fungal infection
Received
November 2, 2007
Accepted
November 27, 2007
Jpn. J. Chemother. 56 (2): 190-201, 2008
