For oral use Initial U.S. Approval: 2023
As specified in the prescribing information, Orserdu (elacestrant) is indicated for the treatment of breast cancer disease. As per highlights Of prescribing information (elacestrant) tablets is an estrogen receptor antagonist indicated for: • treatment of postmenopausal women or adult men, with ERpositive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Facts about elacestrant tablets
Disease Indications: Breast Cancer
Dosage Forms And Strengths: Tablets: 345 mg and 86 mg
Manufacturer: Stemline Therapeutics
Medicine Approved By: Food and Drug Administration (FDA)
Orserdu (elacestrant) was approved by the FDA in January 2023
- Full prescribing information [FDA]: Orserdu (elacestrant) [PDF] Stemline Therapeutics, Inc., January 2023.
- FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer FDA, January 2023
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Query For elacestrant tablets
Approved accessible "elacestrant tablets"
Elacestrant is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Elacestrant was approved for medical use in the United States in January 2023.
Elacestrant is an antiestrogen, or an antagonist of the estrogen receptors, the biological targets of endogenous estrogens such as estradiol. The most common side effects of elacestrant include musculoskeletal pain, nausea, increased cholesterol, elevated liver enzymes, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, increased AST, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flashes, and upset stomach.
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