Elacestrant
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 {{{adverseReactions}}}.
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.