July 30, 2013 — Guerbet has announced that Cincinnati Children's Hospital Medical Center (Cincinnati Children's) last week performed the first U.S. injection of Dotarem (gadoterate meglumine), the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) approved by the U.S. Food and Drug Administration (FDA). The procedure was performed in a school age child.
Dotarem is indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Dotarem was approved by the FDA in March 2013 and was released for the U.S. market in early July. Cincinnati Children's was the first hospital to order the product in the United States. In the past year, Cincinnati Children's performed 18,000 total MRIs, with more than 6,600 performed as contrast-enhanced MRIs.
Dotarem — which has been commercialized widely outside the United States since 1989 and more than 37 million doses administered (according to data on file as of Jan. 1, 2013) — is the only macrocyclic and ionic GBCA. The recommended dose is 0.2 mL/kg (0.1 mmol/kg) body weight (BW). Dotarem Injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine and is available in vials and pre?filled syringes.
For more information: www.guerbet.com