Black Box Warning

Gadolinium-based contrast agents (GBCAs) increase the risk of 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 injury of any severity due to hepatorenal syndrome or in the perioperative liver transplantation period. Screen patients for renal dysfunction before GBCA administration. Avoid GBCA use in these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI. GBCAs cause gadolinium retention for months or years, particularly in the bone, brain, skin, and other organs. The retention is greater after multiple administrations and at higher doses. Linear GBCAs cause more retention than macrocyclic GBCAs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal renal function. Ensure appropriate patient hydration before administering GBCAs to reduce the risk of NSF.