IMPORTANT SAFETY INFORMATION
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
See Indications and additional Important Safety Information about Omniscan at the bottom of this page.
Dear Healthcare Professional Letter– Gadolinium Retention Important Drug Warning for All Gadolinium-Based Contrast Agents.
OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to:
- Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues
- Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space
MRI contrasts, such as Omniscan may be an appropriate choice for eligible patients and procedures based on its clinical profile and a long tradition of patient and clinician experience. Benefits of Omniscan include:
- It has been used in a clinical setting for more than 15 years in more than 40 million contrast-enhanced MRI scans.1
- Available in +PLUSPAKTM polymer bottle packaging.
1. Data on file. GE Healthcare. 2011.