Gadopiclenol 0.5mmol/ml solution for injection 10ml pre-filled syringes

There are no available data on gadopiclenol use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The available human data on GBCA exposure during pregnancy and adverse fetal outcomes are limited and inconclusive.
[L49866]


In animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadopiclenol during organogenesis.

Because of the potential risks of gadolinium to the fetus, use gadopiclenol only if imaging is essential during pregnancy and cannot be delayed.
[L49866]


In subjects that received a single intravenous dose of gadopiclenol (0.3 mmol/kg) that corresponded to 6 times the recommended dose, headache and nausea were the most frequently reported adverse reactions. Gadopiclenol can be removed from the body by hemodialysis.
[L43817]
Carcinogenicity studies of gadopiclenol have not been performed. Gadopiclenol showed no evidence of mutagenicity in in vitro and in vivo assays.

An in vivo study performed in rats showed that up to 10 mmol/kg (62 times the recommended human dose), gadopiclenol did not affect fertility and general reproductive performance.
[L43817]