FDA Approves First Macrocyclic and Ionic Gadolinium-Contrast Agent for MRI


March 22, 2013

Guerbet announced that the U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) 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 — which has been commercialized widely throughout the world since 1989 and more than 37 million doses administered[1] — 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.

MRI has become the mainstay of central nervous system imaging since its introduction more than 20 years ago. It is estimated that there were more than 10 million contrast-enhanced MRI examinations performed in the United States in 2011, with approximately 60 percent of these examinations performed to image the CNS.

The possibility of serious or life-threatening anaphylactoid/anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, should be considered.

In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging. Screen all patients for renal impairment by obtaining a history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal dysfunction.

Side effects to Dotarem were uncommon in clinical trials. However, the most common adverse reactions associated with Dotarem in clinical studies were nausea, headache, injection site pain, injection site coldness, and burning sensation.

For more information: www.guerbet.com