ORSERDU

COMPOSITION
Elacestrant………………………………345mg
INDICATION
ORSERDU 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.
PACKAGING: 30 tablets per bottle.
Reg No: 11 L 1258/24
Download ORSERDU Drug Registration Certificate

Brand name: ORSERDU


Composition:
Each tablet contains:
Elacestrant………………………………345mg


Indications:
ORSERDU 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.


Dosage:
• The recommended dosage of ORSERDU is one 345 mg tablet taken orally, once daily, with food.
• Dose interruption, reduction, or permanent discontinuation may be required due to adverse reactions.


Contraindications:
• Contraindications include factors that may increases the risk of side effects (eg, hypertension or concomitant use of certain drugs) and therefore is not usually recommended for treatment.


Warnings:
• Dyslipidemia: ORSERDU may cause hypercholesterolemia and hypertriglyceridemia. Monitor lipid profile prior to starting treatment and periodically thereafter.
• Embryo-Fetal Toxicity: ORSERDU can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception.


Adverse Effects:
The most common (>10%) adverse reactions, including laboratory abnormalities, of ORSERDU were 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 flush, and dyspepsia.


Dosage form: Light blue tablets


Expiry date: 24 months from the date of manufacture.


Packaging: 30 tablets per bottle.


Storage:
• Protected from light, sealed in original packaging, and stored at 20 – 25℃.
• Keep out of reach of children.


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