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Clinical Therapeutics

Pharmacokinetics and Safety of Intravenous Voriconazole in Children after Single- or Multiple-Dose Administration

Thomas J. Walsh, Mats O. Karlsson, Timothy Driscoll, Adriano G. Arguedas, Peter Adamson, Xavier Saez-Llorens, Ajay J. Vora, Antonio C. Arrieta, Jeffrey Blumer, Irja Lutsar, Peter Milligan, Nolan Wood
Thomas J. Walsh
1National Cancer Institute and
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  • For correspondence: walsht@mail.nih.gov
Mats O. Karlsson
2Bethesda, Maryland; Uppsala University, Uppsala, Sweden
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Timothy Driscoll
3Duke University Medical Center, Durham, North Carolina
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Adriano G. Arguedas
4Instituto Costarricense de Invetigaciones Clinicas and National Children's Hospital, San Jose, Costa Rica
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Peter Adamson
5Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
6Pediatric Pharmacology Unit, National Institute of Child Health and Human Development
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Xavier Saez-Llorens
7Hospital del Niños, Ciudad de Panama, Panama
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Ajay J. Vora
8Sheffield Children's Hospital, Sheffield
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Antonio C. Arrieta
9Children's Hospital of Orange County, Orange, California
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Jeffrey Blumer
6Pediatric Pharmacology Unit, National Institute of Child Health and Human Development
10University Hospitals of Cleveland, Cleveland, Ohio
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Irja Lutsar
11Pfizer Global Research and Development, Sandwich, Kent, United Kingdom
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Peter Milligan
11Pfizer Global Research and Development, Sandwich, Kent, United Kingdom
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Nolan Wood
11Pfizer Global Research and Development, Sandwich, Kent, United Kingdom
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DOI: 10.1128/AAC.48.6.2166-2172.2004
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ABSTRACT

We conducted a multicenter study of the safety, tolerability, and plasma pharmacokinetics of the parenteral formulation of voriconazole in immunocompromised pediatric patients (2 to 11 years old). Single doses of 3 or 4 mg/kg of body weight were administered to six and five children, respectively. In the multiple-dose study, 28 patients received loading doses of 6 mg/kg every 12 h on day 1, followed by 3 mg/kg every 12 h on day 2 to day 4 and 4 mg/kg every 12 h on day 4 to day 8. Standard population pharmacokinetic approaches and generalized additive modeling were used to construct the structural pharmacokinetic and covariate models used in this analysis. In contrast to that in adult healthy volunteers, elimination of voriconazole was linear in children following doses of 3 and 4 mg/kg every 12 h. Body weight was more influential than age in accounting for the observed variability in voriconazole pharmacokinetics. Elimination capacity correlated with the CYP2C19 genotype. Exposures were similar at 4 mg/kg every 12 h in children (median area under the concentration-time curve (AUC), 14,227 ng · h/ml) and 3 mg/kg in adults (median AUC, 13,855 ng · h/ml). Visual disturbances occurred in 5 (12.8%) of the 39 patients and were the only drug-related adverse events that occurred more than once. No withdrawals from the study were related to voriconazole. We conclude that pediatric patients have a higher capacity for elimination of voriconazole per kilogram of body weight than do adult healthy volunteers and that dosages of 4 mg/kg may be required in children to achieve exposures consistent with those in adults following dosages of 3 mg/kg.

  • Copyright © 2004 American Society for Microbiology
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Pharmacokinetics and Safety of Intravenous Voriconazole in Children after Single- or Multiple-Dose Administration
Thomas J. Walsh, Mats O. Karlsson, Timothy Driscoll, Adriano G. Arguedas, Peter Adamson, Xavier Saez-Llorens, Ajay J. Vora, Antonio C. Arrieta, Jeffrey Blumer, Irja Lutsar, Peter Milligan, Nolan Wood
Antimicrobial Agents and Chemotherapy May 2004, 48 (6) 2166-2172; DOI: 10.1128/AAC.48.6.2166-2172.2004

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Pharmacokinetics and Safety of Intravenous Voriconazole in Children after Single- or Multiple-Dose Administration
Thomas J. Walsh, Mats O. Karlsson, Timothy Driscoll, Adriano G. Arguedas, Peter Adamson, Xavier Saez-Llorens, Ajay J. Vora, Antonio C. Arrieta, Jeffrey Blumer, Irja Lutsar, Peter Milligan, Nolan Wood
Antimicrobial Agents and Chemotherapy May 2004, 48 (6) 2166-2172; DOI: 10.1128/AAC.48.6.2166-2172.2004
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KEYWORDS

antifungal agents
Pyrimidines
triazoles

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