title: FondaKIDS: a prospective pharmacokinetic and safety study of fondaparinux in children between 1 and 18 years of age.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Children's Hospital Los Angeles, University of Southern California, Keck School of Medicine, Los Angeles, California 90027, USA. gyoung@chla.usc.edu
authors.forename: Guy
authors.initials: G
authors.lastname: Young
authors.forename: Donald L
authors.initials: DL
authors.lastname: Yee
authors.forename: Sarah H
authors.initials: SH
authors.lastname: O'Brien
authors.forename: Rachna
authors.initials: R
authors.lastname: Khanna
authors.forename: April
authors.initials: A
authors.lastname: Barbour
authors.forename: Diane J
authors.initials: DJ
authors.lastname: Nugent
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions; D000077425:Fondaparinux; D006493:Heparin / Q000009:adverse effects; D006801:Humans; D007223:Infant; D011134:Polysaccharides / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D013921:Thrombocytopenia / Q000139:chemically induced / Q000188:drug therapy*; D013997:Time Factors; D020246:Venous Thrombosis / Q000188:drug therapy*
chemical_list: D011134:Polysaccharides; D006493:Heparin; D000077425:Fondaparinux