Pharmacokinetics and safety of the MRI contrast agent gadoversetamide injection (Optimark) in healthy pediatric subjects

Rational and Objective: This clinical trial examined the pharmacokinetics of gadoversetamide, a magnetic resonance imaging contrast agent, in normal pediatric subjects. Materials and 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.