|
MAGNEVIST® (gadopentetate dimeglumine) Injection
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk of Nephrogenic Systemic Fibrosis in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73 m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients avoid the 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.
MAGNEVIST® (gadopentetate dimeglumine) injection: As with other contrast media,
the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions,
including cardiovascular, respiratory and/or cutaneous manifestations, should always be
considered. As with other paramagnetic contrast agents, caution should be exercised in
patients with renal insufficiency, especially at higher doses. As with other injectable
products, cases of phlebitis and thrombophlebitis have been reported; assessment of the
dosed limb for the development of injection site reactions is recommended.
NSF/NFD Contrast Update
NSF Customer Letter
|
