Technology | March 22, 2013

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

March 21, 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.

“This approval is a major milestone for Guerbet, which has a proud history of providing safe and effective contrast agents to patients worldwide,” said Yves L’Epine, CEO of Guerbet Group. “Dotarem — already a leader in Europe — is a compelling new CNS imaging option for U.S. healthcare providers and enriches our portfolio for improved patient management with diagnostic imaging in the U.S.”

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 about Dotarem, including full Boxed WARNING, please see the Full Prescribing Information.

 

Clinical Studies

The Dotarem New Drug Application included two Phase III clinical studies. These studies evaluated the diagnostic efficacy and safety of Dotarem 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. Both phase III studies evaluated the superiority of the enhanced images over the unenhanced images for central nervous system (CNS) lesion visualization in all three co-primary endpoints. All defined primary and key secondary efficacy analyses were met and support the efficacy of Dotarem at a standard dose of 0.1 mmol/kg BW. In addition to these two studies, 21 supportive clinical studies evaluated the efficacy and safety of Dotarem-enhanced MRI.

For more information: www.guerbet.com

 

Related Content

Canon Medical Receives FDA Clearance for Vantage Orian 1.5T MRI
Technology | Magnetic Resonance Imaging (MRI) | November 15, 2018
Canon Medical Systems USA Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on its new...
Voyageur Minerals to Begin Manufacturing Barium Contrast Products With Chief Medical Supply
News | Contrast Media | November 14, 2018
Voyageur Minerals Ltd. signed a joint venture agreement with Chief Medical Supply Ltd (CM) of Calgary, Alberta to...
Researchers Awarded 2018 Canon Medical Systems USA/RSNA Research Grants
News | Radiology Imaging | November 13, 2018
The Radiological Society of North America (RSNA) Research & Education (R&E) Foundation recently announced the...
Subtle Medical Showcases Artificial Intelligence for PET, MRI Scans at RSNA 2018
News | Artificial Intelligence | November 13, 2018
At the 2018 Radiological Society of North America annual meeting (RSNA 2018), Nov. 25-30 in Chicago, Subtle Medical...
This is the Siemens Magnetom Sola RT edition 1.5T MRI system optimized for radiation therapy displayed for the first time since gaining FDA clearance in 2018. It was displayed at the American Society for Radiotherapy and Oncology (ASTRO) 2018 annual meeting. Read more about this system at ASTRO 2018. #ASTRO18 #ASTRO2018
360 Photos | 360 View Photos | November 07, 2018
This is the Siemens Magnetom Sola RT edition 1.5T MRI system optimized for...
Fans of Opposing Soccer Teams Perceive Games Differently

Image courtesy of University of York

News | Neuro Imaging | October 25, 2018
Scientists have scanned the brains of die-hard soccer fans to find out why supporters of rival teams often have very...
IMRIS, Siemens Strengthen Collaboration in Hybrid OR Neurosurgical Market
News | Hybrid OR | October 24, 2018
IMRIS, Deerfield Imaging, in partnership with Siemens Healthineers, announced a strengthened collaboration to advance...
Carotid Artery MRI Improves Cardiovascular Disease Risk Assessment
News | Magnetic Resonance Imaging (MRI) | October 23, 2018
Magnetic resonance imaging (MRI) measurements of wall thickness in the carotid arteries improve cardiovascular disease...
The Elekta Unity with 1.5T MRI embedded as a targeting system appeared at the annual meeting of the American Society of Radiation Oncology (ASTRO) in San Antonio, Texas. The system is being sold in Europe and could soon enter the U.S. marketplace. (Photo courtesy of Elekta)

The Elekta Unity with 1.5T MRI embedded as a targeting system appeared at the annual meeting of the American Society of Radiation Oncology (ASTRO) in San Antonio, Texas. The system is being sold in Europe and could soon enter the U.S. marketplace. (Photo courtesy of Elekta)

Feature | ASTRO | October 20, 2018 | By Greg Freiherr
A linear accelerator combined with high-field MRI could soon be on the U.S. market. If U.S.