Precautions of Elacestrant

1 Dyslipidemia

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. 

2 Embryo-Fetal Toxicity

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