WARNING: NOT FOR INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
NOT FOR INTRATHECAL USE
Inadvertent intrathecal use of OMNISCAN has caused convulsions, coma, sensory and motor neurologic deficits.
NSF
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepato-renal 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. |
|
The most frequent adverse events during OMNISCAN clinical trials in 1,369 patients, at doses between 0.025 and 0.3 mmol/kg, were headache, dizziness, and nausea. The majority of these adverse events were of mild to moderate intensity. The possibility of a reaction, including serious, life-threatening, fatal anaphylactoid, or cardiovascular reactions, or other idiosyncratic reaction, should always be considered, especially in those patients with a known clinical hypersensitivity. Refer to the boxed warning and warning section of the package insert for acute or chronic renal insufficiency since OMNISCAN is cleared from the body by glomerular filtration. Patients with a history of allergy or drug reaction should be observed for several hours after administration.
|