Elacestrant(Orserdu)
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ORSERDU™ (Elacestrant) is a targeted therapy designed for the treatment of ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. This medication works by inhibiting the estrogen receptor, which is a key driver of cancer cell growth. It is particularly useful for patients who have not responded well to previous endocrine therapies. The drug is available in oral tablet form and is typically administered once daily with food.
ORSERDU™ has been approved for use in postmenopausal women and adult men. However, careful monitoring is required during treatment due to potential side effects such as liver toxicity and dyslipidemia. It is essential to assess liver function regularly and to adjust doses based on the severity of side effects or drug interactions.
Generic name
Elacestrant(Orserdu)
Alternative Names
Orserdu
Indications
Treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following disease progression after ≥1 line of endocrine therapy.
Therapeutic Target
Estrogen receptor-alpha (ERα). Elacestrant binds to ERα, induces receptor degradation via the proteasomal pathway, and inhibits estrogen-dependent tumor proliferation.
Active Ingredients
Elacestrant hydrochloride (equivalent to 345 mg or 86 mg elacestrant free base per tablet).
specifications
345 mg tablets: Bottle of 30 (NDC 72187-0102-3). 86 mg tablets: Bottle of 30 (NDC 72187-0101-3).
Description
Chemical structure: A dihydrochloride salt with molecular formula C30H38N2O2⋅2HClC30H38N2O2⋅2HCl, molecular weight 531.56 g/mol.
Inactive ingredients: Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, and Opadry II Blue coating.
Dosage and Administration
Recommended dose: 345 mg orally once daily with food.
Missed dose: Skip if >6 hours late or after vomiting; resume next scheduled dose.
Dose modifications:
Hepatic impairment: Avoid in severe (Child-Pugh C); reduce to 258 mg in moderate (Child-Pugh B).
Adverse reactions: Two dose reductions (258 mg → 172 mg); discontinue if intolerable after second reduction.
Administration: Swallow whole; avoid crushing/chewing.
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