BETHESDA, MD 21 March 2013—FDA on March 20 approved the marketing of gadoterate meglumine, or Dotarem, for i.v. use before magnetic resonance imaging of the brain, spine, and associated tissues in patients age 2 years or older.
The contrast agent, the agency said, helps radiologists see lesions in the central nervous system.
Gadoterate meglumine is a gadolinium-based contrast agent and as such its labeling (PDF) carries a boxed warning about the risk or nephrogenic systemic fibrosis, the agency said.
Specifically, the boxed warning advises clinicians not to use a gadolinium-based contrast agent in patients with impaired elimination of that type of drug unless the diagnostic information is essential and not otherwise available.
Dotarem’s labeling recommends a dose of 0.2 mL of the contrast agent per kilogram of patient body weight. This dose should be given as an i.v. bolus injection at the rate of about 2 mL/sec in adults and 1–2 mL/sec in children. A follow-up flush of the i.v. access site with 0.9% sodium chloride injection may ensure complete injection of the contrast agent, the labeling notes.
Adverse reactions to gadoterate meglumine occurred in 3.9% of the 2813 patients who received the contrast agent during clinical studies, according to the labeling. The most common of these reactions was nausea, which occurred in 0.6% of the patients. Headache, pain or coldness at the injection, or burning sensation occurred in 0.2–0.5% of the patients.
Dotarem will be marketed by Guerbet LLC USA as a colorless to yellow solution of gadoterate meglumine 0.5 mmol/mL, or 376.9 mg/mL, in glass vials and prefilled syringes.
The 10-mL vials and syringes contain 10 mL of drug solution.
The 20-mL vials and syringes contain 15 or 20 mL of drug solution.
Doses can be given using plastic syringes, but the labeling says administration of those doses must occur immediately after withdrawal of the drug solution from the vial.
A spokesman for Guerbet said the new contrast agent will be available to hospitals and radiology centers this summer.