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EOVIST® Safety Information

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
  • Acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
  • Acute renal insufficiency of any severity due to the hepatorenal syndrome or in the perioperative liver transplantation period
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.

As with other contrast media, the possibility of serious or life-threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered. The most common adverse reactions observed in clinical trials at the recommended dose included feeling hot, nausea and headache.





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