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Abstract #4193

Safety for the Off-label Use of Ferumoxytol in Magnetic Resonance Imaging: Early Results from the FeraSafe Multi-Center Registry™

Kim-Lien Nguyen1, Rola Saouaf2, Cynthia K. Rigsby3, Lindsay M. Griffin4, Mark L. Fogel5, Kevin K. Whitehead5, Mark L. Schiebler4, David E. Newby6, and J. Paul Finn1

1Department of Radiological Sciences and Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States, 2Department of Radiology, Cedars-Sinai Medical Center, Los Angeles, CA, United States, 3Department of Medical Imaging, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, United States, 4Department of Radiology, University of Wisconsin-Madison, Madison, WI, United States, 5Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, PA, United States, 6British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom

Ferumoxytol is approved in the United States (U.S.) for treatment of iron deficiency anemia in chronic kidney disease. However, its superparamagnetic properties can be leveraged for off-label use in MRI. In 2015, the U.S. Food and Drug Administration (FDA) issued a “black-box” warning regarding risk of rare but serious hypersensitivity reactions based on post-marketing surveillance therapeutic use data. Preliminary experience from the FeraSafe Multi-Center RegistryTM suggests a low incidence of adverse events with the off-label diagnostic use of ferumoxytol. To date, these preliminary results suggest that with appropriate clinical use and monitoring, there is an acceptable benefit /risk profile.

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