ORSERDU 86MG/ 345MG TAB (ELACESTRANT)

📘 Introduction

• Brand Name: Orserdu

• Generic Name/Salt: Elacestrant

• Drug Class: Oral selective estrogen receptor degrader 

• Indication:

  • For postmenopausal women and adult men

  • With ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

  • Who progressed after at least one line of endocrine therapy 

💊 Salt & Formulation

• Active Ingredient: Elacestrant

• Dosage Form: Oral tablets

• Strengths Available:

  • 345 mg 

  • 86 mg 

🧪 Dosage & Administration

• Standard Dose: One 345 mg tablet once daily, taken with food

• Administration Notes:

  • Must be swallowed whole; do not chew, crush, or split

  • If a dose is missed or vomiting occurs, skip and resume the next day; do not double up

⚠️ Side Effects

     Common :

• Musculoskeletal pain (41%)

• Nausea (35%)

• Increased cholesterol (30%) & triglycerides (27%)

• Elevated liver enzymes (AST 29%, ALT 17%)

• Fatigue (26%), Vomiting (19%)

• Decreased hemoglobin/anemia (26%)

• GI symptoms: Diarrhea (13%), constipation, abdominal pain (≈11–12%)

• Other: Headache, hot flush, decreased appetite, increased creatinine, sodium imbalance

Serious Adverse Events :

• Musculoskeletal pain (1.7%)

• Nausea (1.3%)

• Fatal events (1.7%): cardiac arrest, septic shock, diverticulitis, etc.

🛡️ Warnings & Precautions

• Dyslipidemia: Monitor lipid profiles; incidence of grade 3–4 hypercholesterolemia and hypertriglyceridemia: 0.9% and 2.2% respectively

• Embryo–Fetal Toxicity:

  • Can cause fetal harm; advise contraception during treatment and for 1 week after last dose

  • Avoid breastfeeding during treatment and for 1 week after

• Hepatic Impairment: Avoid in Child–Pugh C; dose adjustment for moderate impairment

• Fertility: May impair fertility in both men and women

• Drug Interactions:

  • Avoid strong/moderate CYP3A4 inhibitors or inducers (e.g., rifampin, ketoconazole); grapefruit should be avoided

• Contraindications: Pregnancy, severe hepatic impairment, allergy to elacestrant; not studied in pediatrics

✅ Conclusion

Orserdu (elacestrant) is a once-daily oral SERD used for ESR1-mutated ER+/HER2− advanced breast cancer, precisely after progression on prior endocrine-based therapies. It notably improves progression-free survival (median 3.8 months vs. 1.9 months with standard therapy) .
While generally well tolerated, lipid abnormalities and GI effects are common, with serious events in a minority. Careful monitoring—lipids, liver function, drug interactions, and reproductive counseling—is essential for safe use.