Princeton, NJ – November 30, 2021– Guerbet LLC, the US affiliate of Guerbet, a global leader in medical imaging, announces a recent boom for DOTAREM®, (gadoterate meglumine) injection. DOTAREM’s significant increases come in the face of the continued presence of a pandemic and supply chain disruptions. The company shipped more doses of its flagship MRI contrast agent in October than in any other monthly period since its US release in 2013.
“We are making great strides in the U.S. with our flagship product,” says Thomas McLaughlin, Vice President of North America. “DOTAREM is a trusted solution that supports our commitment to radiologists in the MR suite. There's no doubt that our macrocyclic and ionic molecule has the highest kinetic and thermodynamic stability among currently approved GBCAs.”
Since its release in 1989, DOTAREM (gadoterate meglumine) Injection has been a leading MR contrast agent in Europe, Asia, Africa, the Middle East, and South America. DOTAREM received U.S. Food and Drug Administration (FDA) approval in 2013, becoming the first macrocyclic, ionic gadolinium-based contrast agent (GBCA) in the United States. It has become the No. 2 MR contrast agent in the US and is currently No. 1 in the world, with more than 120 million doses delivered in 70 countries.
The news of DOTAREM’s success follows a long legacy of Guerbet committing itself to the radiology community. In the midst of the COVID-19 crisis in 2020, the company mobilized partners and colleagues across the industry to continue making treatment-critical products available to healthcare professionals. In addition, the organization continually supports the industry with research, education, and development, as is the case in their participation in the annual Radiological Society of North America (RSNA) Conference.
For information regarding DOTAREM, visit https://www.guerbet.com/en-us/products-solutions/contrast-agents/dotarem-gadoterate-meglumine-injection/.
Kelly Starkey + 435.901.3278 + email@example.com
At Guerbet, we build lasting relationships so that we enable people to live better. This is our purpose. We are a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging. A pioneer since 95 years in the field of contrast media with over 2,600 people globally, we are continuously innovating with 10% of revenue dedicated to Research & Development and four centers in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid-caps) and generated €712 million in revenue in 2020. For more information, please visit www.guerbet-us.com.
DOTAREM® (gadoterate meglumine) injection Important Safety Information
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
Indications and Usage
DOTAREM® (gadoterate meglumine) injection is a prescription gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
History of clinically important hypersensitivity reactions to DOTAREM.
Warnings and Precautions
Use in Specific Populations
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information, including the patient Medication Guide, for additional important safety information.
Reference: Dotarem [package insert]. Princeton, NJ: Guerbet LLC; Oct 2019.