Elacestrant (el-a-KES-trant)

Treats breast cancer in men or in women who have already stopped menstruating.

Brand Name(s):

Orserdu

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take the medicine with food at about the same time each day to help prevent nausea and vomiting.
• Swallow the tablet whole. Do not chew, crush, or split it. Do not take this medicine if it is broken, cracked, or damaged.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and it is more than 6 hours since your usual time, skip the missed dose and go back to your regular dosing schedule.
• If you vomit after taking a dose, take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how elacestrant works. Tell your doctor if you are using digoxin, efavirenz, fluconazole, itraconazole, rifampin, or rosuvastatin.

Warnings While Using This Medicine:

• Pregnancy after menopause is not likely, but if you think you could be pregnant, tell your doctor. This medicine could harm an unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment and for 1 week after the last dose. Male patients who have female partners should use effective birth control during treatment and for 1 week after the last dose.
• Do not breastfeed during treatment with this medicine and for 1 week after the last dose.
• Tell your doctor if you have kidney disease or liver disease.
• This medicine may increase the level of cholesterol and fat in your blood. Talk to your doctor if you have concerns.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, stomach pain or upset, loss of appetite, nausea, vomiting
• Headache
• Muscle or bone pain
• Tiredness
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088