Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients.
OBJECTIVE
The pharmacokinetics of gadoversetamide were examined in pediatric patients scheduled to undergo contrast-enhanced MRI of the central nervous system.


METHODS
One hundred patients received an intravenous injection of gadoversetamide at a dose of 0.1 mmol/kg for a contrast-enhanced MRI procedure. A subpopulation of 30 patients were enrolled to evaluate the pharmacokinetics of gadoversetamide in patients 2-11 and 12-18 years of age. Serial blood and urine samples were collected before and after the administration of gadoversetamide.


RESULTS
The terminal half-life, initial concentration and area under the curve assessments for gadoversetamide showed no significant (P>.05) differences between the age groups or the sexes. Although no sex-related differences occurred in the volume of distribution or clearance, significant (P<.05) age-related differences were found, but once corrected for body mass or surface area the differences were no longer significant.


CONCLUSIONS
The pharmacokinetic behavior of gadoversetamide was not significantly altered by differences in age or sex in pediatric patients from 2 to 18 years of age. Although significant differences in volumes of distribution, and clearance occurred between the age groups, these differences appeared to depend on body size rather than on age in pediatric patients between 2 and 18 years of age.
Wible
James H
JH
Covidien Imaging Solutions, 675 McDonnell Blvd., Hazelwood, MO 63042, USA. james.wible@covidien.com
Tata
Prasad N V
PN
Napoli
Alicia M
AM
Lowe
Lisa H
LH
Kearns
Gregory L
GL
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D007269:Injections, Intra-Arterial; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008657:Metabolic Clearance Rate; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000493:pharmacokinetics*
D003287:Contrast Media; D009942:Organometallic Compounds; C112666:gadoversetamide