Orserdu

Elacestrant is used to treat certain types of breast cancer. Breast cancer cells need the hormone estrogen to grow. Elacestrant works by blocking the effect of estrogen, slowing or stopping the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start taking elacestrant and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not chew, crush or split the tablets. Do not take tablets that are broken. Taking elacestrant with food may help lessen nausea and vomiting. If you vomit, do not take another dose to catch up. Take your next dose at the regular time.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Muscle/joint pain, tiredness, headache, flushing, diarrhea, constipation, upset stomach, heartburn, nausea, vomiting, or decreased appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking elacestrant, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using elacestrant. Elacestrant may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Men and women using this medication should ask about reliable forms of birth control during treatment and for 1 week after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 1 week after the last dose is not recommended. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of elacestrant from your body, which may affect how elacestrant works. Examples include azole antifungals (such as fluconazole, itraconazole), cobicistat, certain HIV NNRTIs (such as efavirenz), HIV protease inhibitors (such as atazanavir, darunavir), certain macrolide antibiotics (such as clarithromycin, erythromycin), rifamycins (such as rifampin), some drugs used to treat seizures (such as carbamazepine, phenytoin), St. John's wort among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

It is important to get each dose of this medication as scheduled. If you miss a dose, take it as soon as you remember if it is within 6 hours of the missed dose. If it has been longer than 6 hours, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

Lab and/or medical tests (such as liver/kidney function, cholesterol/triglyceride levels, complete blood counts) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.