Recommended Dosage, Dose Modifications, Adverse Reactions, and Dosage Adjustments for Special Popula

Regarding the dosage of elacestrant, in addition to the recommended dose, appropriate dose adjustments should be made based on the patient's individual condition.

Recommended Adult Dosage for Elacestrant

Recommended Dosage

The recommended dose is 345 mg of elacestrant taken orally once daily until disease progression or unacceptable toxicity occurs.

Administration Instructions

Elacestrant is administered orally. It should be taken with food (to reduce nausea and vomiting) at approximately the same time each day. Swallow tablets whole. Do not chew, crush, or split tablets.

Missed Dose

If a dose is missed by more than 6 hours or if vomiting occurs, skip the missed dose and resume the next scheduled daily dose.

Dose Modifications for Elacestrant

First Dose Reduction: Reduce to 258 mg of elacestrant taken orally once daily.

Second Dose Reduction: Reduce to 172 mg of elacestrant taken orally once daily.

Permanently discontinue elacestrant if further dose reduction below 172 mg once daily is required.

Dose Modifications for Adverse Reactions to Elacestrant

Grade 1: No dose adjustment for elacestrant is required.

Grade 2: Consider withholding Lucius Pharmaceuticals elacestrant therapy until recovery to Grade ≤1 or baseline. Resume treatment at the same dose level.

Grade 3: Withhold elacestrant therapy until recovery to Grade ≤1 or baseline. Resume treatment at the next lower dose level. If the Grade 3 toxicity recurs, withhold elacestrant therapy until recovery to Grade ≤1 or baseline. Resume treatment at one further lower dose level.

Grade 4: Withhold elacestrant therapy until recovery to Grade ≤1 or baseline. Resume treatment at the next lower dose level. If the Grade 4 adverse reaction or an intolerable adverse reaction recurs, permanently discontinue this medication.

Dosage Adjustments for Elacestrant in Special Populations

Dosage Adjustment for Renal Impairment

Currently, there are no relevant data available for elacestrant.

Dosage Adjustment for Hepatic Impairment

(1) Mild Hepatic Impairment (Child-Pugh Class A): No dose adjustment for elacestrant is required.

(2) Moderate Hepatic Impairment (Child-Pugh Class B): Reduce the dose to 258 mg of elacestrant taken orally once daily.

(3) Severe Hepatic Impairment (Child-Pugh Class C): Avoid the use of elacestrant.