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Antimicrobial Agents and Chemotherapy, February 2006, p. 632-638, Vol. 50, No. 2
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.2.632-638.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Safety and Pharmacokinetics of Intravenous Anidulafungin in Children with Neutropenia at High Risk for Invasive Fungal Infections

Daniel K. Benjamin Jr.,1 Timothy Driscoll,1 Nita L. Seibel,2 Corina E. Gonzalez,3 Maureen M. Roden,4 Rahki Kilaru,1 Kay Clark,5 James A. Dowell,5 Jennifer Schranz,5 and Thomas J. Walsh4*

Department of Pediatrics and Duke Clinical Research Institute, Duke University, Durham, North Carolina,1 Children's National Medical Center, Washington, D.C.,2 Georgetown University, Washington, D.C.,3 National Cancer Institute, Bethesda, Maryland,4 Vicuron Pharmaceuticals, King of Prussia, Pennsylvania5

Received 17 July 2005/ Returned for modification 10 October 2005/ Accepted 22 November 2005

Anidulafungin is an echinocandin with activity against Candida species and Aspergillus species. Adult dosages under study are 50 mg/day for esophageal candidiasis and 100 mg/day for invasive candidiasis and aspergillosis. Little is known, however, about the safety and pharmacokinetics of anidulafungin in children. A multicenter, ascending-dosage study of neutropenic pediatric patients was therefore conducted. Patients were divided into two age cohorts (2 to 11 years and 12 to 17 years) and were enrolled into sequential groups to receive 0.75 or 1.5 mg/kg of body weight/day. Blood samples were obtained following the first and fifth doses. Anidulafungin was assayed in plasma, and pharmacokinetic parameters were determined. Safety was assessed using National Cancer Institute (NCI) common toxicity criteria. Pharmacokinetic parameters were determined for 12 patients at each dosage (0.75 mg/kg/day or 1.5 mg/kg/day). Concentrations and drug exposures were similar for patients between age cohorts, and weight-adjusted clearance was consistent across age. No drug-related serious adverse events were observed. One patient had fever (NCI toxicity grade of 3), and one patient had facial erythema, which resolved with slowing the infusion rate. Anidulafungin in pediatric patients was well tolerated and can be dosed based on body weight. Pediatric patients receiving 0.75 mg/kg/day or 1.5 mg/kg/day have anidulafungin concentration profiles similar to those of adult patients receiving 50 or 100 mg/day, respectively.

* Corresponding author. Mailing address: Pediatric Oncology Branch, National Cancer Institute, CRC-1-5750, 10 Center Drive, Bethesda, MD 20892. Phone: (301) 496-7103. Fax: (301) 480-2308. E-mail: walsht{at}mail.nih.gov.

Antimicrobial Agents and Chemotherapy, February 2006, p. 632-638, Vol. 50, No. 2
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.2.632-638.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



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