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Antimicrobial Agents and Chemotherapy, March 2009, p. 869-875, Vol. 53, No. 3
0066-4804/09/$08.00+0     doi:10.1128/AAC.00868-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Pharmacokinetics and Safety of Caspofungin in Neonates and Infants Less than 3 Months of Age{triangledown}

Xavier Sáez-Llorens,1 Mercedes Macias,2 Padmanabha Maiya,3 Juan Pineros,4 Hasan S. Jafri,5 Archana Chatterjee,6 Gloria Ruiz,7 Janaki Raghavan,8 Susan K. Bradshaw,9 Nicholas A. Kartsonis,9 Peng Sun,9 Kim M. Strohmaier,9 Marissa Fallon,9 Sheng Bi,9 Julie A. Stone,9 and Joseph W. Chow9*

Hospital del Niño, Panama City, Panama,1 Instituto Nacional de Pediatría, Mexico City, Mexico,2 MS Ramaiah Medical College, Bangalore, India,3 Fundación Santa Fe de Bogotá, Bogotá, Colombia,4 University of Texas Southwestern Medical Center at Dallas, Dallas, Texas,5 Creighton University School of Medicine, Omaha, Nebraska,6 Hospital University San Ignacio, Bogotá, Colombia,7 Kanakamna Ramachandra Hospital, Bangalore, India,8 Merck Research Laboratories, West Point, Pennsylvania9

Received 30 June 2008/ Returned for modification 28 September 2008/ Accepted 3 December 2008

Candida infections represent a major threat in neonatal intensive care units. This is the first prospective study to obtain caspofungin plasma levels and safety data for neonates and very young infants. Patients of <3 months of age receiving intravenous amphotericin B for documented or highly suspected candidiasis were enrolled in a single-dose (n = 6) or subsequent multiple-dose (n = 12) panel; all received caspofungin at 25 mg/m2 once daily as a 1-hour infusion. Caspofungin plasma levels were measured by high-performance liquid chromatography and compared to historical data from adults. Patient chronological ages ranged from 1 to 11 weeks, and weights ranged from 0.68 to 3.8 kg. Gestational ages ranged from 24 to 41 weeks. Geometric mean (GM) peak (C1 h) and trough (C24 h) caspofungin levels were 8.2 and 1.8 µg/ml, respectively, on day 1, and 11.1 and 2.4 µg/ml, respectively, on day 4. GM ratios for C1 h and C24 h for neonates/infants relative to adults receiving caspofungin at 50 mg/day were 1.07 and 1.36, respectively, on day 1, and 1.18 and 1.21, respectively, on day 4. Clinical and laboratory adverse events occurred in 17 (94%) and 8 (44%) patients, respectively. Five patients (28%) had serious adverse events, none of which were considered drug related. Caspofungin at 25 mg/m2 once daily was well tolerated in this group of neonates/infants of <3 months of age and appears to provide relatively similar plasma exposure to that obtained in adults receiving 50 mg/day. However, the small number of patients studied precludes any definitive recommendations about caspofungin dosing for this group comprising a broad range of ages and weights.

* Corresponding author. Mailing address: Merck Research Laboratories, P.O. Box 1000, UG3D-56, North Wales, PA 19454-1099. Phone: (267) 305-7203. Fax: (267) 305-6477. E-mail: joseph_chow{at}merck.com

{triangledown} Published ahead of print on 15 December 2008.

Antimicrobial Agents and Chemotherapy, March 2009, p. 869-875, Vol. 53, No. 3
0066-4804/09/$08.00+0     doi:10.1128/AAC.00868-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • VandenBussche, H. L, Van Loo, D. A (2010). A Clinical Review of Echinocandins in Pediatric Patients. The Annals of Pharmacotherapy 44: 166-177 [Abstract] [Full Text]  
  • Neely, M., Jafri, H. S., Seibel, N., Knapp, K., Adamson, P. C., Bradshaw, S. K., Strohmaier, K. M., Sun, P., Bi, S., Dockendorf, M. F., Stone, J. A., Kartsonis, N. A. (2009). Pharmacokinetics and Safety of Caspofungin in Older Infants and Toddlers. Antimicrob. Agents Chemother. 53: 1450-1456 [Abstract] [Full Text]  


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