Your Health, We Care
Hypercholesterolemia and hypertriglyceridemia occurred in patients taking Elacestrant at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively.
Monitor lipid profile prior to starting and periodically while taking Elacestrant.
Based on findings in animals and its mechanism of action, Elacestrant can cause fetal harm when administered to a pregnant woman. Administration of elacestrant to pregnant rats resulted in adverse developmental outcomes, including embryo-fetal mortality and structural abnormalities, at maternal exposures below the recommended dose based on area under the curve (AUC).
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Elacestrant and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Elacestrant and for 1 week after the last dose.
from FDA，2023.05
