French contrast developer Guerbet has received approval for its Dotarem (gadoterate meglumine) MRI contrast agent from the U.S. Food and Drug Administration (FDA).
Dotarem is indicated for MRI scans of the brain, spine, and associated tissues of patients ages 2 years and older to detect and visualize areas with disruption of the blood-brain barrier and/or abnormal vascularity. The recommended dose is 0.1 mmol Gd/kg, according to Guerbet.
Dotarem's safety and effectiveness were established in a clinical trial of 245 adult and 38 pediatric patients ages 2 years and older with suspected central nervous system (CNS) abnormalities. Compared with baseline images acquired without Dotarem, the agent helped radiologists better see CNS lesions, and it also helped them identify lesion borders and other lesion features. Similar results were obtained in a clinical trial conducted among patients who were known to have CNS abnormalities, according to the FDA.
An FDA advisory panel in February gave the agent a unanimous recommendation for use in patients older than 2 years, while voting 10-6 with one member abstaining against recommending approval in children younger than 2.
Like other gadolinium-based contrast agents, Dotarem will carry a boxed warning about the risk of nephrogenic systemic fibrosis (NSF), which is associated with gadolinium-based MRI contrast in some patients with kidney disease. NSF is characterized by pain and thickening of the skin and can cause fibrosis of internal organs.
Dotarem is the seventh gadolinium-based contrast agent approved by the FDA for use in patients undergoing MRI scans of the central nervous system.
