Elacestrant

Elacestrant
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rithish Nimmagadda,MBBS.[2]

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Overview

Elacestrant is an estrogen receptor antagonist that is FDA approved for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor type 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer that has progressed following ≥1 line of endocrine-based therapy in postmenopausal women or adult men.. Common adverse reactions include Adverse effects (≥10%): musculoskeletal pain, nausea, vomiting, increased cholesterol, increased AST/ALT, increased triglycerides, fatigue, decreased hemoglobin, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, dyspepsia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Dosage of elacestrant hydrochloride is expressed in terms of elacestrant.

Two doses available -

-86 mg (of elacestrant) 345 mg (of elacestrant)

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Elacestrant FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

None

Warnings

-Dyslipidemia

Hypercholesterolemia and hypertriglyceridemia reported, including grade 3 and 4 events. Monitor lipid profile prior to starting elacestrant and periodically during treatment.

-Fetal/Neonatal Morbidity and Mortality

Can cause fetal harm if used during pregancy based on findings from animal studies and drug mechanism of action. [ref] Fetal structural abnormalities and embryofetal death demonstrated in animals.

Verify pregnancy status in females of reproductive potential prior to initiating elacestrant. Apprise patients of the potential hazard to the fetus if elacestrant is used during pregnancy. May impair fertility; advise females of reproductive potential, and males with female partners of reproductive potential, to use effective contraception during treatment and for 1 week after the last dose.

Adverse Reactions

Clinical Trials Experience

Adverse effects (≥10%): musculoskeletal pain, nausea, vomiting, increased cholesterol, increased AST/ALT, increased triglycerides, fatigue, decreased hemoglobin, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, dyspepsia

Postmarketing Experience

There is limited information regarding Elacestrant Postmarketing Experience in the drug label.

Drug Interactions

Moderate and Strong CYP3A4 Inhibitors

May increase elacestrant exposure and consequently increase risk for toxicity. Avoid concomitant use.

-Moderate and Strong CYP3A4 Inducers

May decrease elacestrant exposure and consequently reduce efficacy of elacestrant. Avoid concomitant use.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): May cause fetal harm based on findings in an animal study and drug mechanism of action
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Elacestrant in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Elacestrant during labor and delivery.

Nursing Mothers

Unknown whether elacestrant distributes into human milk, or affects milk production or the breast-fed infant.

Pediatric Use

There is no FDA guidance on the use of Elacestrant in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Elacestrant in geriatric settings.

Gender

There is no FDA guidance on the use of Elacestrant with respect to specific gender populations.

Race

There is no FDA guidance on the use of Elacestrant with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Elacestrant in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Elacestrant in patients with hepatic impairment.

Females of Reproductive Potential and Males

Perform pregnancy testing in females of reproductive potential prior to treatment initiation.

May impair fertility in females and males of reproductive potential based on animal study findings.

Immunocompromised Patients

There is no FDA guidance one the use of Elacestrant in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Elacestrant Administration in the drug label.

Monitoring

There is limited information regarding Elacestrant Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Elacestrant and IV administrations.

Overdosage

There is limited information regarding Elacestrant overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Elacestrant Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Elacestrant Mechanism of Action in the drug label.

Structure

There is limited information regarding Elacestrant Structure in the drug label.

Pharmacodynamics

There is limited information regarding Elacestrant Pharmacodynamics in the drug label.

Pharmacokinetics

Peak plasma concentrations and AUC increase more than proportionally across dosage range of 43–862 mg once daily (0.125–2.5 times the approved recommended dosage). Steady state is reached by day 6.

Time to achieve peak plasma concentration ranges from 1–4 hours.

Oral bioavailability approximately 10%.

Nonclinical Toxicology

There is limited information regarding Elacestrant Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Elacestrant Clinical Studies in the drug label.

How Supplied

There is limited information regarding Elacestrant How Supplied in the drug label.

Storage

There is limited information regarding Elacestrant Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Elacestrant Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Elacestrant interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

Orserdu®

Look-Alike Drug Names

There is limited information regarding Elacestrant Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.