|Manufacturer:||Bracco Diagnostics Inc.|
Manufactured for Bracco Diagnostics Inc.Princeton, NJ 08543 by Nycomed GmbH - 78224 Singen (Germany)Revised September 2007 F1/3.5552.90
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) and in patients with 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 MRI.
For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a gadolinium-based contrast agent in order to enhance the contrast agent’s elimination.
The usefulness of hemodialysis in the prevention of NSF is unknown.Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a gadolinium-based contrast agent and the degree of renal function impairment at the time of exposure.Post-marketing reports have identified the development of NSF following single and multiple administrations of gadolinium-based contrast agents.
These reports have not always identified a specific agent.
Where a specific agent was identified, the most commonly reported agent was gadodiamide (OmniscanTM), followed by gadopentetate dimeglumine (Magnevist®) and gadoversetamide (OptiMARK®).
NSF has also developed following sequential administrations of gadodiamide with gadobenate dimeglumine (MultiHance®) or gadoteridol (ProHance®).
The number of post-marketing reports is subject to change over time and may not reflect the true proportion of cases associated with any specific gadolinium-based contrast agent.The extent of risk for NSF following exposure to any specific gadolinium-based contrast agent is unknown and may vary among the agents.
Published reports are limited and predominantly estimate NSF risks with gadodiamide.
In one retrospective study of 370 patients with severe renal insufficiency who received gadodiamide, the estimated risk for development of NSF was 4% (J Am Soc Nephrol 2006;17:2359).
The risk, if any, for the development of NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown.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 prior to any readministration.(See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).