Gadavist Gets FDA Nod

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imageGadavist (gadobutrol), a gadolinium-based contrast agent (GBCA), has received FDA approval for use in patients undergoing MRI of the central nervous system. Manufactured by Bayer Pharmaceuticals, Gadavist provides contrast-enhanced imaging of the central nervous system, helping to detect and visualize lesions that disrupt the cell barrier that normally separates the brain from the blood stream. It also helps to detect and visualize abnormal blood supply and circulation of the central nervous system.

"Gadavist MRI scans improved the visualization of lesions in the central nervous system when compared to MRI scans without contrast," notes Libero Marzella, MD, acting division director, Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research.

Gadavist is the sixth gadolinium-based contrast agent (GBCA) approved by the FDA for this purpose. It is indicated for adults and children ages two years and older. Gadavist is more concentrated than the other GBCAs and should be administered at half the volume, according to the manufacturer. Two clinical studies involving 657 patients and other trial data established the safety and efficacy of Gadavist. Those receiving Gadavist during the studies reported headache and nausea as the most common adverse reactions. Other adverse events associated with the GBCA included hypersensitivity reactions, involving cardiovascular, respiratory, or skin effects ranging from mild to severe.

All GBCAs, including Gadavist, carry a boxed warning about the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition for which there is no known treatment. Characterized by pain and thickening of the skin, NSF has been associated with the use of GBCAs in certain patients with kidney dysfunction.Gadavist is currently considered to be among GBCAs with a lower risk of NSF, and is not one of the GBCAs that is contraindicated in patients with acute kidney injury or chronic, severe kidney disease.