Selinexor

Selinexor is used along with dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) that has returned or that did not respond to at least 4 other treatments. Selinexor is also used with bortezomib and dexamethasone to treat multiple myeloma in patients who have previously been treated with at least one other medication. It is also used to treat certain types of diffuse large B-cell lymphoma (DLBCL; a type of cancer that begins in the white blood cells) in adults whose cancer has returned or is unresponsive to at least two other treatments. Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by killing cancer cells.

Selinexor comes as a tablet to take by mouth with or without food. For use in combination with dexamethasone for the treatment of multiple myeloma or for the treatment of DLBCL, selinexor is usually taken on days 1 and 3 of each week. For use in combination with bortezomib and dexamethasone for the treatment of multiple myeloma, selinexor is usually taken once a week. Take selinexor at around the same time of day every day that you take it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take selinexor 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 with water; do not split, chew, or crush them.

If you vomit after taking selinexor, do not take another dose. Continue your regular dosing schedule.

Your doctor may tell you to take medication to prevent nausea and vomiting before and during your treatment with selinexor.

Your doctor may need to stop or interrupt your treatment or reduce your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with selinexor.

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

Before taking selinexor,

• tell your doctor and pharmacist if you are allergic to selinexor, any other medications, or any of the ingredients in selinexor tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or recently have had an infection, if you have or have had bleeding problems, or if you have cataracts (clouding of the lens of the eye).
• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a negative pregnancy test before you start taking selinexor. If you are a female, you should not become pregnant while you are taking selinexor and for up to 1 week after your final dose. Talk to your doctor about birth control methods that will work for you. If you are male, you and your female partner should use birth control during your treatment and continue to use birth control for 1 week after your final dose. If you or your partner become pregnant while taking selinexor, call your doctor immediately. Selinexor may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking selinexor and for 1 week after your final dose.
• you should know that this medication may decrease fertility in men and women.
• you should know that selinexor may make you drowsy or cause dizziness or fainting. Do not drive a car or operate machinery until you know how this medication affects you.

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

Your doctor will also probably recommend that you drink enough liquids and eat enough calories during your treatment.

If you miss a dose, skip that dose and take your medication at your next regularly scheduled day and time. Do not take a double dose to make up for a missed one.

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

• nausea
• vomiting
• diarrhea
• constipation
• weight loss
• loss of appetite
• extreme tiredness
• difficulty falling asleep or staying asleep
• headache
• taste changes

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

• easy bleeding or bruising
• fatigue, pale skin, or shortness of breath
• fever, cough, chills, or other signs of infection
• seeing things or hearing voices that do not exist
• confusion
• blurred or double vision
• increased sensitivity to light and glare

Selinexor 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 (https://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. https://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 (https://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 monitor your body weight and order certain lab tests before and during your treatment to check your body's response to selinexor.

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.

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