Elacestrant Dosage
Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.
Applies to the following strengths: 86 mg; 345 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Breast Cancer
345 mg orally once a day with food
Duration of therapy: Until disease progression or unacceptable toxicity
Use: For the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Mild liver dysfunction (Child-Pugh A): No adjustment recommended
Moderate liver dysfunction (Child-Pugh B): 258 mg orally once a day with food
Severe liver dysfunction (Child-Pugh C): Avoid use
Dose Adjustments
Avoid concomitant use with strong or moderate CYP450 3A4 inducers and inhibitors.
DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
- Grade 1: No adjustment recommended
- Grade 2:
- Consider interruption of therapy until recovery to Grade 1 or less, or baseline.
- Resume at same dosing level.
- Grade 3:
- Interrupt therapy until recovery to Grade 1 or less, or baseline. Then resume therapy reduced by one dose level.
- If Grade 3 toxicity returns, interrupt therapy until recovery to Grade 1 or less, or baseline. Then resume therapy with reduction by another dose level.
- Grade 4:
- Interrupt therapy until recovery to Grade 1 or less, or baseline. Then resume therapy reduced by one dose level.
- If Grade 4 or intolerable adverse reaction reoccurs, permanently discontinue drug.
DOSE REDUCTION LEVELS FOR ADVERSE REACTIONS:
- First-dose reduction: 258 mg orally once a day
- Second-dose reduction: 172 mg orally once a day
- If reduction below 172 mg once a day is required, permanently discontinue drug.
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Administer this drug with food and at approximately the same time each day.
- Do not chew, crush, or split tablets prior to swallowing
- If a dose is missed for more than 6 hours or vomiting occurs, skip the dose and resume with the next scheduled daily dose.
Storage requirements:
- Store at room temperature 20C to 25C (68F to 77F).
- Excursions permitted from 15C to 30C (59F to 86F).
General:
- Tablets available in 345 mg and 86 mg strengths
Monitoring:
- Monitor lipid profile prior to starting therapy and periodically during treatment.
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
- This drug may cause elevated cholesterol and/or triglycerides; lipid profile monitoring is recommended.
- This drug should be avoided by those with severe liver dysfunction.
- Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, dietary and herbal supplements, so possible interactions can be evaluated.
- Fetal harm may occur with this drug; avoid pregnancy during treatment.
- Women who are able to become pregnant and men with partners who are able to become pregnant should use birth control during treatment and for at least 1 week after stopping treatment. If pregnancy occurs, contact your doctor immediately.
- The fertility of males and females may be compromised by this drug.
- Do not breastfeed during therapy and for 1 week after the last dose.
More about elacestrant
- Check interactions
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- Side effects
- During pregnancy
- Drug class: estrogen receptor antagonists
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