Dosage of Elacestrant

1 Patient Selection

Select patients for treatment of ER-positive, HER2-negative advanced or metastatic breast cancer with Elacestrant based on the presence of ESR1 mutation(s) in plasma specimen using an FDA-approved test.  

2 Recommended Dosage

The recommended dosage of Elacestrant is 345 mg taken orally with food once daily until disease progression or unacceptable toxicity occurs. 

Take Elacestrant at approximately the same time each day. Take with food to reduce nausea and vomiting. 

Swallow Elacestrant tablet(s) whole. Do not chew, crush, or split prior to swallowing. Do not take any Elacestrant tablets that are broken, cracked, or that look damaged.  

If a dose is missed for more than 6 hours or vomiting occurs, skip the dose and take the next dose the  following day at its regularly scheduled time. 

3 Dosage Modifications for Adverse Reactions

The recommended dose reduction levels for adverse reactions are listed in Table 1:

Recommended dosage modifications of Elacestrant for adverse reactions are provided in Table 2.

4 Dosage Modifications for Use with Concomitant CYP3A4 Inducers and Inhibitors

Avoid concomitant use of Elacestrant with strong or moderate CYP3A4 inducers and inhibitors. 

5 Dosage Modifications for Hepatic Impairment

Avoid use of Elacestrant in patients with severe hepatic impairment (Child-Pugh C). Reduce the Elacestrant  dosage to 258 mg once daily for patients with moderate hepatic impairment (Child-Pugh B). No dosage  adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A).

from FDA，2023.05