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