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FondaKIDS: A prospective pharmacokinetic and safety study of fondaparinux in children between 1 and 18 years of age
Author(s) -
Young Guy,
Yee Donald L.,
O'Brien Sarah H.,
Khanna Rachna,
Barbour April,
Nugent Diane J.
Publication year - 2011
Publication title -
pediatric blood and cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.116
H-Index - 105
eISSN - 1545-5017
pISSN - 1545-5009
DOI - 10.1002/pbc.23011
Subject(s) - fondaparinux , medicine , dosing , pharmacokinetics , discontinuation , incidence (geometry) , thrombosis , deep vein , prospective cohort study , anesthesia , venous thromboembolism , physics , optics
Background The incidence of thromboembolic disease is increasing in children. New anticoagulants have been licensed in adults and need to be studied in children. This report describes the first prospective study of fondaparinux in children. Procedure The purpose of the study was to determine the dosing, pharmacokinetics, and safety of fondaparinux in children with deep vein thrombosis (DVT) or heparin‐induced thrombocytopenia (HIT). Hospitalized children between 1 and 18 years of age with DVT or HIT received fondaparinux 0.1 mg/kg once daily. Fondaparinux‐based anti‐factor Xa levels were assessed at 2, 4, 12, and 24 hr following the first dose, and peak levels were measured twice weekly thereafter. Detailed pharmacokinetic analyses were performed. Results Twenty four subjects in 3 age cohorts were enrolled and completed the study. Pharmacokinetic modeling demonstrated that a once‐daily dose of fondaparinux at 0.1 mg/kg resulted in similar concentrations known to be efficacious in adults. Safety was demonstrated with only two bleeding events: one which may have pre‐dated study drug administration and one which led only to temporary discontinuation of study drug. Conclusion Dosing of fondaparinux at 0.1 mg/kg once daily in children resulted in PK profiles comparable to those in adults receiving standard dosing. Fondaparinux can be considered an attractive alternative to LMWH given its once‐daily dosing, acceptable safety data, and other favorable properties. Pediatr Blood Cancer 2011; 57: 1049–1054. © 2011 Wiley‐Liss, Inc.