Elacestrant

Treatment should be initiated by a physician experienced in the use of anticancer therapies. Patients with ER-positive, HER2-negative advanced breast cancer must be selected on the presence of an activating ESR1 mutation in plasma using a CE-marked IVD (or an alternative validated test). Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity. Missed dose: may be taken within 6 hours of the usual time; after more than 6 hours skip that day's dose and resume at the usual time the next day. Vomiting after a dose: do not take an additional dose that day. Dose reduction: 258 mg once daily (three 86 mg tablets); if a further reduction below 258 mg once daily is required, discontinue. Grade 2 - consider interruption until recovery to Grade 1 or baseline then resume at the same level; Grade 3 - interrupt until recovery then resume at 258 mg once daily, permanently discontinue if a Grade 3 or intolerable reaction recurs after that; Grade 4 - interrupt until recovery then resume at 258 mg once daily, permanently discontinue on recurrence. CYP3A4 inhibitors: avoid strong and moderate inhibitors; if a strong inhibitor must be used, reduce elacestrant to 86 mg once daily; if a moderate inhibitor must be used, reduce to 172 mg once daily (subsequent reduction to 86 mg may be considered on tolerability); return to the previous dose 5 half-lives after the inhibitor is stopped. No adjustment with mild CYP3A4 inhibitors. CYP3A4 inducers: avoid strong and moderate inducers; if a strong or moderate inducer is needed for 3 days or less, or intermittently, continue elacestrant without increasing the dose. No adjustment with mild inducers. Hepatic impairment: mild (Child-Pugh A) no adjustment; moderate (Child-Pugh B) reduce to 258 mg; severe (Child-Pugh C) reduce to 86 mg. Elderly: no adjustment on the basis of age, limited data at 75 years and over. Paediatric: safety and efficacy in children from birth to 18 years have not been established and no data are available.