Elacestrant Dosage

Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer