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Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections.

Publication ,  Journal Article
Benjamin, DK; Driscoll, T; Seibel, NL; Gonzalez, CE; Roden, MM; Kilaru, R; Clark, K; Dowell, JA; Schranz, J; Walsh, TJ
Published in: Antimicrob Agents Chemother
February 2006

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.

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Published In

Antimicrob Agents Chemother

DOI

ISSN

0066-4804

Publication Date

February 2006

Volume

50

Issue

2

Start / End Page

632 / 638

Location

United States

Related Subject Headings

  • Peptides, Cyclic
  • Neutropenia
  • Mycoses
  • Microbiology
  • Male
  • Humans
  • Female
  • Echinocandins
  • Child, Preschool
  • Child
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Benjamin, D. K., Driscoll, T., Seibel, N. L., Gonzalez, C. E., Roden, M. M., Kilaru, R., … Walsh, T. J. (2006). Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections. Antimicrob Agents Chemother, 50(2), 632–638. https://doi.org/10.1128/AAC.50.2.632-638.2006
Benjamin, Daniel K., Timothy Driscoll, Nita L. Seibel, Corina E. Gonzalez, Maureen M. Roden, Rahki Kilaru, Kay Clark, James A. Dowell, Jennifer Schranz, and Thomas J. Walsh. “Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections.Antimicrob Agents Chemother 50, no. 2 (February 2006): 632–38. https://doi.org/10.1128/AAC.50.2.632-638.2006.
Benjamin DK, Driscoll T, Seibel NL, Gonzalez CE, Roden MM, Kilaru R, et al. Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections. Antimicrob Agents Chemother. 2006 Feb;50(2):632–8.
Benjamin, Daniel K., et al. “Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections.Antimicrob Agents Chemother, vol. 50, no. 2, Feb. 2006, pp. 632–38. Pubmed, doi:10.1128/AAC.50.2.632-638.2006.
Benjamin DK, Driscoll T, Seibel NL, Gonzalez CE, Roden MM, Kilaru R, Clark K, Dowell JA, Schranz J, Walsh TJ. Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections. Antimicrob Agents Chemother. 2006 Feb;50(2):632–638.

Published In

Antimicrob Agents Chemother

DOI

ISSN

0066-4804

Publication Date

February 2006

Volume

50

Issue

2

Start / End Page

632 / 638

Location

United States

Related Subject Headings

  • Peptides, Cyclic
  • Neutropenia
  • Mycoses
  • Microbiology
  • Male
  • Humans
  • Female
  • Echinocandins
  • Child, Preschool
  • Child