The Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine; Guerbet) for intravenous use with magnetic resonance imaging (MRI) in pediatric patients <2 years old, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS). Previously, Dotarem was approved for patients over the age of two.

The approval was based on a study (n=51) which showed that at the standard dose, the pharmacokinetic and safety profiles for this gadolinium-based contrast agent were similar for patients under the age of 2 and in older children and adults. The image evaluations from contrast-enhanced MRI of the CNS were consistent with the extrapolated CNS efficacy findings observed in adults and older children. 

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Dotarem, a macrocyclic and ionic gadolinium-based contrast medium, develops a magnetic moment when placed in a magnetic field. It works by enhancing the relaxation rates of water protons in its vicinity, leading to an increase in brightness of tissues. 

Dotarem is available as a 0.5mmol/mL strength solution in 10mL and 20mL vials and prefilled syringes. 

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