ESTROGEN RECEPTOR ANTAGONIST
Overview
Orserdu is approved by the U.S. Food and Drug Administration (FDA) for treating postmenopausal women and adult men with estrogen receptor-positive (ER-positive), HER2-negative, ESR1-mutated advanced, or metastatic breast cancer who have experienced disease progression after at least one line of endocrine therapy. To be eligible for treatment with Orserdu, a person must have a confirmed ESR1 mutation. Orserdu is also known by its drug name, elacestrant.
Elacestrant belongs to the ER antagonist category. It works by blocking the effects of estrogen on cancer cells, which can slow or stop the growth of certain types of breast cancer that rely on estrogen for their growth and survival.
How do I take it?
Prescribing information states that Orserdu is taken orally once daily with food. It is important to take Orserdu exactly as prescribed by a health care provider.
Side effects
Common side effects of Orserdu include musculoskeletal pain, nausea, increased cholesterol levels, elevated aspartate aminotransferase (AST), increased triglycerides, fatigue, decreased hemoglobin, vomiting, elevated alanine aminotransferase (ALT), low sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flushes, and dyspepsia (indigestion).
Rare but serious side effects may include dyslipidemia (high cholesterol and triglyceride levels) and embryo-fetal toxicity (harm to an embryo, fetus, or unborn infant). Additionally, Orserdu should be used cautiously by individuals with moderate hepatic impairment (liver damage) and avoided by those with severe hepatic impairment. Drug interactions with CYP3A4 inducers and inhibitors are also a concern.
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Label: Orserdu — Elacestrant Tablets, Film Coated — DailyMed