Pharmacokinetics and safety of the MRI contrast agent gadoversetamide injection (OptiMARK) in healthy pediatric subjects.
OBJECTIVE
This clinical trial examined the pharmacokinetics of gadoversetamide, a magnetic resonance imaging contrast agent, in normal pediatric subjects.


METHODS
Seventeen healthy pediatric subjects received a single intravenous injection of gadoversetamide (0.1 mmol/kg, 0.2 mL/kg). Sixteen subjects that were evaluable for pharmacokinetic analysis fell into 2 stratified age groups: 2 years to <5 years and 5 years to <18 years of age. Serum samples were analyzed for total gadolinium as a measure of gadoversetamide concentration.


RESULTS
Statistical analysis demonstrated significant (P < 0.05) age-related trends in the mean elimination half-life (t 1/2) of gadolinium with the older group having a slightly longer t 1/2 (1.39 hours) than the younger group (1.19 hours). No age-related changes occurred in volume of distribution or total body clearance, when normalized to body weight or body surface area.


CONCLUSIONS
Based on this preliminary pharmacokinetic assessment, no adjustment from the approved adult gadoversetamide dose of 0.1 mmol/kg should be necessary for children aged 2 or older.
Baker
James F
JF
Tyco Healthcare/Mallinckrodt Inc., 675 McDonnell Boulevard, St. Louis, MO 63134, USA.
Kratz
Linda C
LC
Stevens
Gary R
GR
Wible
James H
JH
D000293:Adolescent; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous; D008279:Magnetic Resonance Imaging; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000493:pharmacokinetics*; D012449:Safety
D003287:Contrast Media; D009942:Organometallic Compounds; C112666:gadoversetamide