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Elacestrant tablets LuciElace elacestrant ORSERDU
Elacestrant is an estrogen receptor antagonist indicated for the treatment of postmenopausal women or adult men with ER-positive, HER2-negative, *ESR1*-mutated advanced or metastatic breast cancer that has progressed following at least one line of endocrine therapy.
Description
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Product Description
Product Name: LuciElace
Manufacturer: Lucius Pharmaceutical (Laos) Co., Ltd.
Chinese Name: Elacestrant Tablets
English Name: Elacestrant Tablets
Specifications: 345 mg × 30 tablets/box; 86 mg × 30 tablets/box
[Indications]
LuciElace is an estrogen receptor antagonist indicated for the treatment of:
Advanced or metastatic breast cancer in postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and *ESR1*-mutated disease, whose disease has progressed following at least one line of endocrine therapy.
[Dosage and Administration]
Select patients for treatment with LuciElace based on the presence of an *ESR1* mutation.
The recommended dosage of LuciElace is one 345 mg tablet taken orally once daily, with food.
Dosage interruption, reduction, or permanent discontinuation may be required based on adverse reactions.
[Contraindications] None.
[Warnings and Precautions]
Dyslipidemia: LuciElace may cause hypercholesterolemia and hypertriglyceridemia. Monitor blood lipid levels prior to initiating treatment and periodically thereafter.
Embryo-Fetal Toxicity: LuciElace may cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception.
[Adverse Reactions]
The most common (>10%) adverse reactions (including laboratory abnormalities) with LuciElace are musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flashes, and dyspepsia.
[Drug Interactions]
Strong and Moderate CYP3A4 Inducers: Avoid concomitant use with LuciElace.
Strong and Moderate CYP3A4 Inhibitors: Avoid concomitant use with LuciElace.
[Use in Specific Populations]
Lactation: Advise patients not to breastfeed.
Hepatic Impairment: Avoid use in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose for patients with moderate hepatic impairment (Child-Pugh B).
[Storage]
Store at 20°C to 25°C (68°F to 77°F); excursions between 15°C and 30°C (59°F and 86°F) are permitted. Protect from moisture.
