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Antimicrobial Agents and Chemotherapy, November 2005, p. 4536-4545, Vol. 49, No. 11
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.11.4536-4545.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Pharmacokinetics, Safety, and Tolerability of Caspofungin in Children and Adolescents

Thomas J. Walsh,1* Peter C. Adamson,2 Nita L. Seibel,3 Patricia M. Flynn,4 Michael N. Neely,5 Cindy Schwartz,6 Aziza Shad,7 Sheldon L. Kaplan,8 Maureen M. Roden,1 Julie A. Stone,9 Alisha Miller,9 Susan K. Bradshaw,9 Susan X. Li,9 Carole A. Sable,9 and Nicholas A. Kartsonis9

National Cancer Institute, Bethesda, Maryland,1 Children's Hospital of Pennsylvania, Philadelphia, Pennsylvania,2 Children's National Medical Center, Washington, D.C.,3 St. Jude Children's Research Hospital, Memphis, Tennessee,4 Rainbow Babies & Children Hospital, Cleveland, Ohio,5 Johns Hopkins Hospital—Baystate, Baltimore, Maryland,6 Georgetown Hospital, Washington, D.C.,7 Texas Children's Hospital, Houston, Texas,8 Merck Research Laboratories, West Point, Pennsylvania9

Received 20 August 2004/ Returned for modification 9 November 2004/ Accepted 28 March 2005

Caspofungin is a parenteral antifungal that inhibits beta-1,3-D-glucan synthesis. Although licensed for adult use, the appropriate caspofungin dosing regimen in pediatric patients is not yet known. We therefore investigated the pharmacokinetics and safety of caspofungin in pediatric patients. Thirty-nine children (ages 2 to 11 years) and adolescents (ages 12 to 17 years) with neutropenia were administered caspofungin using either a weight-based regimen (1 mg/kg of body weight/day) or a body surface area regimen (50 mg/m2/day or 70 mg/m2/day). Plasma samples for caspofungin profiles were collected on days 1 and 4. These results were compared to those from adults treated with either 50 or 70 mg/day for mucosal candidiasis. In children receiving 1 mg/kg/day (maximum, 50 mg/day), the area under the concentration-time curve over 24 h (AUC0-24) was significantly smaller (46% after multiple doses) than that observed in adults receiving 50 mg/day (P < 0.001). In children and adolescents receiving 50 mg/m2/day (maximum, 70 mg/day), the AUC0-24 following multiple doses was similar to that for the exposure in adults receiving 50 mg/day. The AUC0-24 and concentration trough (at 24 h) in pediatric patients receiving the 50-mg/m2 daily regimen were consistent across the range of ages. Caspofungin was generally well tolerated in this study. None of the patients developed a serious drug-related adverse event or were discontinued for toxicity. These results demonstrate that caspofungin at 1 mg/kg/day in pediatric patients is suboptimal. Caspofungin administration at 50 mg/m2/day provides a comparable exposure to that of adult patients treated with 50 mg/day.

* Corresponding author. Mailing address: Immunocompromised Host Section, Pediatric Oncology Branch, National Cancer Institute, Bldg. 10-CRC, Room 1W-5750, 10 Center Drive, Bethesda, MD 20892. Phone: (301) 402-0023. Fax: (301) 480-2308. E-mail: walsht{at}mail.nih.gov.

Antimicrobial Agents and Chemotherapy, November 2005, p. 4536-4545, Vol. 49, No. 11
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.11.4536-4545.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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