The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.

Dotarem is a gadolinium-based contrast agent (GBCA) that helps radiologists see abnormalities on images of the central nervous system (CNS), the part of the body that contains the brain and spine, and surrounding tissues.

“Dotarem was shown to be a safe and effective magnetic resonance imaging agent in patients ages 2 years and older,” said Dwaine Rieves, M.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides doctors with another option to help evaluate anatomic abnormalities within the central nervous system.”

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 CNS abnormalities. Each patient received a baseline MRI without Dotarem, and then the MRI was repeated following Dotarem administration.

Results showed that, in comparison to the baseline images, Dotarem MRI helped radiologists better see CNS lesions. Dotarem also helped the radiologists 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.

All GBCAs, including Dotarem, carry a boxed warning about the risk of nephrogenic systemic fibrosis (NSF), a rare but serious condition associated with the use of GBCAs in certain patients with kidney disease. NSF is characterized by pain and thickening of the skin, and can cause fibrosis of internal organs. There is no known treatment for NSF, and all approved, professional GBCA labeling describes ways to minimize the NSF risk.

Side effects to Dotarem were uncommon in clinical trials. However, the most commonly reported side effects were nausea, headache, pain or coldness at the injection site, and burning sensation.

Dotarem is the seventh GBCA approved by the FDA for use in patients undergoing CNS MRI. Other FDA-approved GBCAs with a CNS MRI indication include Magnevist (1988), Prohance (1992), Omniscan (1993), Optimark (1999), Multihance (2004) and Gadavist (2011).

Dotarem is marketed by Bloomington, Ind.-based Guerbet LLC.

Source: FDA.