Dose-finding and pharmacokinetic profiles of prophylactic doses of a low molecular weight heparin (reviparin-sodium) in pediatric patients.
BACKGROUND
The low molecular weight heparin (LMWH), reviparin-sodium was studied in dose-finding and pharmacokinetic studies in children with central venous lines (CVLs).


METHODS
The dose-finding study was performed in 24 patients aged 3 days to 16 years. Dose adjustments were made using a nomogram based on anti-factor Xa levels (units (U)/ml) (target of 0.1-0.3 U/ml). The pharmacokinetic study was performed in 19 patients, 9 less than or equal to 5 kg (7 of whom were less than 3 months) and 10 greater than 5 kg (all more than 3 months).


RESULTS
The dose-finding study demonstrated that children over 5 kg required 30 International Units (IU)/kilogram (kg), subcutaneous (SC) twice daily (BID), and children less than or equal to 5 kg required 50 IU/kg, SC BID, to achieve target levels. The pharmacokinetic study demonstrated that 80% of anti-factor Xa levels were within the target range with both patient groups having similar peak (average=0.26 U/ml) and trough (average=0.13 U/ml) levels.


CONCLUSIONS
Peak anti-factor Xa levels (0.1-0.3 U/ml) using reviparin-sodium are achieved by administering 50 IU/kg in children greater than 3 months of age and 30 U/kg in children less than 3 months of age.
Massicotte
Patricia
P
Department of Pediatrics, Division of Hematology/Oncology, Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto, Ontario, Canada M5G 1X8. patricia.massicotte@sickkids.ca
Julian
Jim A
JA
Marzinotto
Velma
V
Gent
Michael
M
Shields
Karen
K
Chan
Anthony K
AK
Szechtman
Barbara
B
Kohne
Steven
S
Shepherd
Steven
S
Bacher
Peter
P
Andrew
Maureen
M
D000293:Adolescent; D002405:Catheterization, Central Venous / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000209:etiology / Q000378:metabolism* / Q000517:prevention & control*
D006495:Heparin, Low-Molecular-Weight; C094240:reviparin