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Orserdu

elacestrant
Oral SERD FDA Approved 2023 Menarini
Route
Oral
Half-Life
~33 hrs
FDA Approved
2023
Manufacturer
Menarini
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1. Indications and Usage

ESR1-mutated ER+/HER2- advanced BC.

2. Dosage and Administration

345 mg daily with food.

3. Dosage Forms and Strengths

Tablets: 86, 172, 345 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Dyslipidemia: Monitor.
  • Hepatotoxicity: Monitor LFTs.
  • Embryo-Fetal Toxicity: Fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Musculoskeletal Pain (41%), Nausea (35%), Triglycerides (35%), Cholesterol (31%), Fatigue (27%), Decreased Appetite (19%)

Musculoskeletal Pain
41%
Nausea
35%
Triglycerides
35%
Cholesterol
31%
Fatigue
27%
Decreased Appetite
19%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Avoid strong CYP3A4 modulators.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Oral SERD promoting ER degradation, active vs ESR1 mutations.

Pharmacokinetics

t1/2: ~30h.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Orserdu Trials on ClinicalTrials.gov ↗ 📚 PubMed: Orserdu Clinical Trials ↗
FDA-Approved Tumor Types

Orserdu has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Breast Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Orserdu. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Orserdu (elacestrant) approved for?

Orserdu (elacestrant) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Orserdu (elacestrant) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Orserdu (elacestrant) work?

Oral SERD promoting ER degradation, active vs ESR1 mutations.

What are the most common side effects?

Musculoskeletal Pain (41%), Nausea (35%), Triglycerides (35%), Cholesterol (31%), Fatigue (27%), Decreased Appetite (19%) Musculoskeletal Pain 41% Nausea 35% Triglycerides 35% Cholesterol 31% Fatigue 27% Decreased Appetite 19%

← All Therapies Full Prescribing Information ↗