Gadobutrol

Prior to administration of gadobutrol, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.

There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30 ml/min/1.73 m²). Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.

As there is a possibility that NSF may occur with gadobutrol, it should therefore only be used in patients with severe renal impairment and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI).

Haemodialysis shortly after gadobutrol administration may be useful at removing gadobutrol from the body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.

There are no data from the use of gadobutrol in pregnant women. Animal studies have shown reproductive toxicity at repeated high doses.

Gadobutrol should not be used during pregnancy unless the clinical condition of the woman requires use of gadobutrol.

Gadolinium containing contrast agents are excreted into breast milk in very small amounts. At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut. Continuing or discontinuing of breast feeding for a period of 24 hours after administration of gadobutrol, should be at the discretion of the doctor and lactating mother.

Fertility

Animal studies do not indicate impairment of fertility.

Not relevant.