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Nephrogenic Systemic Fibrosis - Bayer Warning on Magnevist

Update to the latest warnings on NSF - Bayer has revised its package insert to clearly state the following warning regarding Magnevist administration in patient's with renal failure and the associated risk for NSF.

 

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 hepato-renal syndrome or in the perioperative liver transplantation period.

In clinical trials, the most frequently reported adverse events included headache, nausea, and injection site coldness. 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.

Please read more at Bayer's Website on Magnevist

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