|Name||2-[4,7-bis(carboxylatomethyl)-10-(carboxymethyl)-1,4,7, 10-tetrazacyclododec-1-yl]acetate; gadolinium(3+); (2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol|
March 20, 2013 — 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 (gadoterate meglumine)
Treatment for: Diagnostic
Dotarem (gadoterate meglumine) is a gadolinium-based contrast agent under review for use in magnetic resonance imaging (MRI).
Dotarem is the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) for the intravenous use with magnetic resonance imaging (MRI) in the brain (intracranial), spine and associated tissues in adults and pediatric patients to detect and visualize areas with disruption of the blood-brain barrier (BBB) and/or abnormal vascularity. The Guerbet NDA recommended dose is 0.1 mmol Gd/kg.
Gadoteric acid (trade names Artirem, Dotarem) is a macrocycle-structured gadolinium-based MRI contrast agent. It consists of the organic acid DOTA as a chelating agent, and gadolinium (Gd3+), and is used in form of the meglumine salt. The drug is approved and used in a number of countries worldwide.
- Herborn, C. U.; Honold, E.; Wolf, M.; Kemper, J.; Kinner, S.; Adam, G.; Barkhausen, J. (2007). “Clinical Safety and Diagnostic Value of the Gadolinium Chelate Gadoterate Meglumine (Gd-DOTA)”. Investigative Radiology 42 (1): 58–62. doi:10.1097/01.rli.0000248893.01067.e5. PMID 17213750. edit
- Drugs.com: Gadoteric Acid
A gadolinium chelate paramagnetic contrast agent. When placed in a magnetic field, gadoterate meglumine produces a large magnetic moment and so a large local magnetic field, which can enhance the relaxation rate of nearby protons; as a result, the signal intensity of tissue images observed with magnetic resonance imaging (MRI) may be enhanced. Because this agent is preferentially taken up by normal functioning hepatocytes, normal hepatic tissue is enhanced with MRI while tumor tissue is unenhanced. In addition, because gadobenate dimeglumine is excreted in the bile, it may be used to visualize the biliary system using MRI.