WARNING — NOT FOR INTRATHECAL USE: Inadvertent intrathecal use of Omniscan has caused convulsions, coma, sensory, and motor neurologic deficits.
WARNING — NEPHROGENIC SYSTEMIC FIBROSIS (NSF): Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted magnetic resonance imaging (MRI) or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Do not administer Omniscan to patients with chronic, severe kidney disease (glomerular filtration rate [GFR] <30 mL/min/1.73m2) or acute kidney injury (AKI). Screen patients for AKI and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age >60 years, hypertension, or diabetes), estimate GFR via laboratory testing. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration