The U.S. Food and Drug Administration (FDA) has approved Clariscan™, a macrocyclic, ionic, gadolinium-based, MRI contrast agent, expanding the GE Healthcare portfolio for U.S. patients and
The U.S. Food and Drug Administration (FDA) has approved Clariscan™, a macrocyclic, ionic, gadolinium-based, MRI contrast agent, expanding the GE Healthcare portfolio for U.S. patients and radiologists. Clariscan is a 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 to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Clariscan has been approved in more than 55 countries globally and has had more than four million patient doses shipped in those countries. It is the latest in a growing range of imaging agents available in the U.S. from GE Healthcare. For more than 40 years, GE agents have been routinely used across MRI, X-ray/CT and ultrasound to enhance the image and support diagnosis.
“Demand for contrast media has significantly increased over the past decade. The introduction of Clariscan increases our clinical offering for U.S. radiologists, enhancing visualization to provide better patient care. Our customers rely on our high-quality products, first-rate supply network, and surrounding services to support their day-to-day work,” explained Kevin O’Neill, President & CEO Pharmaceutical Diagnostics at GE Healthcare.
“The FDA’s approval of this macrocyclic MR agent adds to the range of contrast media options available here in the U.S. and as radiologists we welcome this broader choice,” said Dr. Lawrence N Tanenbaum, M.D., FACR.
GE Healthcare offers diagnostic imaging agents used in approximately 90 million procedures per year globally, equivalent to three patients every second. In the U.S., GE Healthcare has a strong record of innovation in new contrast media products and indications, with recent FDA approvals for Omnipaque™ (iohexol) in CT of the abdomen and for Visipaque™ (iodixanol) in coronary CT angiography. GE Healthcare has invested $240 million in its global manufacturing and supply network over the past five years to deliver imaging agents to hospitals and pharmacies globally.
Clariscan is manufactured in Norway using a proprietary manufacturing process. As with all GE Healthcare contrast media products, all stages of manufacturing, from development of the active pharmaceutical ingredient (API) to finished product, are managed entirely by GE Healthcare. Clariscan is available in single dose vials of 10, 15 and 20 mL. The packaging contains a 2D data matrix (barcode) on every Clariscan pack, which conveys key information, including national drug code number, individual lot number, and expiration date. This information can be easily scanned and uploaded onto electronic medical systems, helping to reduce the risk of manual data entry errors and helping workflow efficiencies at medical centers.
About GE Healthcare:
GE Healthcare is the $19.8 billion healthcare business of GE (NYSE: GE). As a leading provider of medical imaging, monitoring, biomanufacturing, and cell and gene therapy technologies, GE Healthcare enables precision health in diagnostics, therapeutics and monitoring through intelligent devices, data analytics, applications and services. With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, the company helps improve outcomes more efficiently for patients, healthcare providers, researchers and life sciences companies around the world. Follow us on Facebook, LinkedIn, Twitter and The Pulse for latest news, or visit our website https://corporate.gehealthcare.com/ for more information.
CLARISCANTM (gadoterate meglumine) injection for intravenous use
PRODUCT INDICATIONS AND USE:
CLARISCAN™ (gadoterate meglumine) is a 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 to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Additional pediatric use information is approved for Guerbet LLC’s Dotarem (gadoterate meglumine injection). However, due to Guerbet LLC’s marketing exclusivity, this drug product is not labeled with that pediatric information.
IMPORTANT SAFETY INFORMATION ABOUT CLARISCANTM
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.
History of clinically important hypersensitivity reactions to Clariscan.
Warnings and precautions
Use in specific populations
Additional pediatric use information is approved for Guerbet, LLC’s Dotarem (gadoterate meglumine injection). However, due to Guerbet LLC’s marketing exclusivity, this drug product is not labeled with that pediatric information.
Prior to Clariscan administration please read the full Prescribing Information, including the Boxed Warning and patient Medication Guide, for additional important safety information at:
To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800-654-0118 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional safety information for Omnipaque™, please see full Prescribing Information at https://www.gehealthcare.com/-/jssmedia/c66966a70fe946afa829483a1d6c848c.pdf?la=en-us
For additional safety information for Visipaque™, please see full Prescribing Information at https://www.gehealthcare.com/-/jssmedia/1f0478f5573f47538b0e4bdcc619ac3c.pdf?la=en-us
November 2019 JB72654US