Elacestrant is used to treat certain types of hormone receptor-positive breast cancer (breast cancer that depends on hormones such as estrogen to grow) in adults who have had disease progression following treatment with at least one other hormone therapies. Elacestrant is in a class of medications called estrogen receptor antagonists. It works by stopping growth of cancer cells, dependent on estrogen, by blocking the ability of estrogen to bind.

Elacestrant comes as a tablet to take by mouth. It is usually taken with food once a day. Take elacestrant at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take elacestrant exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor may need to change your dose or tell you to stop taking elacestrant based on side effects you may experience. Be sure to tell your doctor how you are feeling while taking the medicine. Do not stop taking the medicine until your doctor tells you to.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking elacestrant,

• tell your doctor and pharmacist if you are allergic to elacestrant, any other medications, or any of the ingredients in elacestrant tablet. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking elacestrant. Some medications should not be used with elacestrant or your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially St. John’s Wort.
• tell your doctor if you have or have ever had liver disease or high cholesterol.
• tell your doctor if you are pregnant, plan to become pregnant, or plan to father a child. You should not become pregnant while you are receiving elacestrant. You may need to have a negative pregnancy test before you begin receiving this medication. Use effective birth control during your treatment with elacestrant and for 1 week after your final dose. If you are male and your partner can become pregnant, you should use effective birth control during your treatment and for 1 week after your final dose. If you or your partner becomes pregnant while receiving elacestrant, call your doctor. You should not breastfeed while receiving elacestrant or for 1 week following your last dose.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is has been more than 6 hours from the missed dose or you vomited, skip the dose and resume the regular schedule with the next dose. Do not take a double dose to make up for a missed one.

Elacestrant may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Muscle and joint pain
• tiredness or weakness
• vomiting
• decreased appetite
• diarrhea
• constipation
• abdominal pain
• hot flush
• indigestion or heartburn

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• lower abdominal pain, yellowing of skin or eyes, or dark urine
• nausea, headache, confusion or fatigue

Elacestrant may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to elacestrant.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Orserdu^®