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 Registry^TM 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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