Elacestrant
Breast Neoplasms
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Estrogen Receptor Antagonist
Controlled Drug Substance
No
Elacestrant
Summary
Elacestrant is used to treat hormone receptor-positive breast cancer in adults, particularly postmenopausal women and men, who have seen disease progression after other hormone therapies.
Elacestrant is an estrogen receptor antagonist. It works by binding to the estrogen receptors and blocking estrogen from attaching to them. This is crucial in stopping the growth of certain breast cancer cells that depend on estrogen.
The usual daily dose for adults is 345 mg, taken orally with food once daily. The tablets should be swallowed whole without chewing, crushing, or splitting them.
Common side effects of Elacestrant include musculoskeletal pain, nausea, fatigue, vomiting, and diarrhea. Serious adverse effects can include severe musculoskeletal pain and nausea.
Elacestrant may cause fetal harm if administered to pregnant women. It may also pass into breast milk, so breastfeeding is not recommended during treatment and for one week after the last dose. The drug is contraindicated in patients with severe hepatic impairment.
Indications and Purpose
How does Elacestrant work?
Elacestrant is an estrogen receptor antagonist that binds to estrogen receptor-alpha (ERα). It inhibits estrogen-mediated cell proliferation by blocking estrogen from binding to its receptor, which is crucial for the growth of certain breast cancer cells.
Is Elacestrant effective?
The efficacy of Elacestrant was evaluated in the EMERALD trial, a randomized, open-label, multicenter study. It showed a statistically significant improvement in progression-free survival for patients with ER-positive, HER2-negative advanced breast cancer with ESR1 mutations compared to standard care.
What is Elacestrant?
Elacestrant is used to treat certain types of hormone receptor-positive breast cancer in adults who have had disease progression after other hormone therapies. It works by blocking estrogen from binding to its receptor, stopping the growth of cancer cells that depend on estrogen.
Directions for Use
For how long do I take Elacestrant?
Elacestrant is typically used until disease progression or unacceptable toxicity occurs. The exact duration varies based on individual response and tolerance.
How do I take Elacestrant?
Take Elacestrant once daily with food to reduce nausea and vomiting. Swallow the tablets whole without chewing, crushing, or splitting them. There are no specific food restrictions, but avoid grapefruit and grapefruit juice as they can interact with the medication.
How should I store Elacestrant?
Store Elacestrant at room temperature, between 68°F to 77°F (20°C to 25°C). Keep it in its original container, tightly closed, and out of reach of children. Avoid storing it in the bathroom to prevent exposure to moisture.
What is the usual dose of Elacestrant?
The usual daily dose for adults is 345 mg taken orally with food once daily. The safety and effectiveness of Elacestrant in children have not been established.
Warnings and Precautions
Can Elacestrant be taken safely while breastfeeding?
It is not known if Elacestrant passes into breast milk. Due to the potential for serious adverse reactions in the breastfed child, women should not breastfeed during treatment with Elacestrant and for one week after the last dose.
Can Elacestrant be taken safely while pregnant?
Elacestrant can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment and for one week after the last dose. There is no available human data, but animal studies show adverse developmental outcomes.
Can I take Elacestrant with other prescription drugs?
Avoid using Elacestrant with strong or moderate CYP3A4 inducers and inhibitors, as they can alter Elacestrant's effectiveness and increase the risk of side effects. Consult your doctor about all medications you are taking to avoid potential interactions.
Is Elacestrant safe for the elderly?
No overall differences in safety or effectiveness of Elacestrant were observed between patients 65 years or older compared to younger patients. However, there are insufficient data for patients 75 years or older to assess differences in safety or effectiveness. Elderly patients should be monitored closely for side effects.
Is it safe to exercise while taking Elacestrant?
Elacestrant may cause fatigue, which could limit the ability to exercise. If you experience fatigue, it's important to listen to your body and rest as needed. Consult your doctor for personalized advice on exercise while taking Elacestrant.
Who should avoid taking Elacestrant?
Important warnings for Elacestrant include the risk of dyslipidemia and embryo-fetal toxicity. Patients should monitor lipid levels and use effective contraception during treatment. Avoid use with strong CYP3A4 inducers and inhibitors. Elacestrant is contraindicated in patients with severe hepatic impairment.
