Elacestrant Dosage

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

Usual Adult Dose for Breast Cancer

Recommended dose: 345 mg orally once a day with food
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Select patients for treatment based on the presence of ESR1 mutations in plasma specimens using an FDA-approved test.

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): Reduce dose to 258 mg orally once a day
Severe liver dysfunction (Child-Pugh C): Avoid use

Dose Adjustments

DOSE REDUCTION LEVELS:

• First-dose reduction: Reduce to 258 mg orally once a day
• Second-dose reduction: Reduce to 172 mg orally once a day
• Permanently discontinue this drug if a dose reduction below 172 mg orally once a day is required.

DOSE MODIFICATIONS FOR ADVERSE REACTIONS:

• Grade 1: No adjustment recommended
• Grade 2: Consider interruption until recovery to grade 1 or less, or baseline. Then resume therapy at the same dose 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 dosing level.
• Grade 4: Interrupt therapy until recovery to grade 1 or less, or baseline. Then resume therapy reduced by one dose level.
• Permanently discontinue therapy if Grade 4 or intolerable adverse reaction reoccurs

CONCOMITANT USE WITH CYP450 3A4 INDUCERS AND INHIBITORS: Avoid coadministration

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:

• For oral use
• Administer with food (to reduce nausea and vomiting) at approximately the same time each day.
• Swallow tablets whole; do not chew, crush, or split tablets.
• If a dose is missed for more than 6 hours or if 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:

• Information on FDA-approved tests for the detection of ESR1 mutations in plasma specimens is available at: http://www.fda.gov/CompanionDiagnostics.

Monitoring:

• Assess lipid profile prior to starting therapy and periodically during treatment.

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Take this drug with food.
• Understand that lipid profile monitoring is recommended prior to and periodically during treatment.
• Tell your doctor about all the medications you take, including prescription and over-the-counter drugs.
• Inform your health care provider of a known or suspected pregnancy; use effective contraception during treatment and for at least 1 week after stopping treatment.
• Recognize that therapy may impair fertility in males and females of reproductive potential.
• Do not breastfeed during therapy and for 1 week after the last dose.

See also:

Further information

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

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