Selinexor is used together with bortezomib and/or dexamethasone to treat multiple myeloma in adults.

Selinexor is also used in adults to treat certain types of diffuse large B-cell lymphoma.

Selinexor is given after other medications did not work or have stopped working.

Selinexor was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to selinexor, but further studies are needed.

Selinexor may also be used for purposes not listed in this medication guide.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, flu symptoms, cough, mouth ulcers, or trouble breathing,

Selinexor can also cause low platelet counts in your blood. Tell your doctor right away if you have unusual bruising or bleeding.

Your doctor will perform tests to make sure selinexor is the right treatment for you.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Selinexor is usually taken only on specific days, once or twice per week. Follow your doctor's instructions very carefully about when and how to take selinexor with dexamethasone and/or bortezomib.

Your doctor will determine how long to treat you with selinexor and dexamethasone.

Take selinexor with a full glass of water. Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking selinexor, do not take another dose. Take your next dose as scheduled.

You may be given other medications to help prevent nausea, vomiting, or infections. Keep taking these medicines for as long as your doctor has prescribed.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests. You may need a transfusion if your blood platelets get too low.

Your blood sodium levels will need to be tested. If the levels get too low, your doctor may prescribe salt tablets or intravenous (IV) fluids to keep you from getting dehydrated.

Drink plenty of liquids to prevent dehydration, and eat enough calories to prevent weight loss.

Selinexor can affect your appetite or ability to eat. You will be weighed before and during treatment to make sure you are not losing weight while taking selinexor.

Store at room temperature away from moisture and heat. Keep each selinexor tablet in the blister pack until you are ready to take your dose.

Usual Adult Dose for Multiple Myeloma:

IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE (SVd):
100 mg orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with bortezomib 1.3 mg/m2 subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off; dexamethasone 20 mg orally twice weekly on Days 1 and 2 of each week

IN COMBINATION WITH DEXAMETHASONE:
80 mg orally on Day 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20 mg orally with each dose of selinexor on Days 1 and 3 of each week

Comments:
-For additional information regarding the administration of bortezomib and dexamethasone, refer to its prescribing information.
-Consider IV hydration for patients at risk of dehydration.
-Provide prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents prior to and during therapy.

Uses:
-In combination with bortezomib and dexamethasone for patients with multiple myeloma who have received at least 1 prior therapy
-In combination with dexamethasone for patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody

Usual Adult Dose for Lymphoma:

60 mg orally on Day 1 and 3 of each week until disease progression or unacceptable toxicity

Comments:
-Consider IV hydration for patients at risk of dehydration.
-Provide prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents prior to and during therapy.

Use: For the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy

Tell your doctor if you have ever had:

• cataracts;

• bleeding problems; or

• an active or recent infection.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using selinexor should use effective birth control to prevent pregnancy. Selinexor can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using selinexor.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because selinexor can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Not approved for use by anyone younger than 18 years old.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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.

Avoid driving or hazardous activity until you know how selinexor will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Selinexor can cause serious or fatal side effects. Some side effects may not occur until you have been taking this medicine for several days or weeks.

Selinexor may cause serious side effects. Call your doctor at once if you have:

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• severe ongoing nausea, vomiting, or diarrhea;

• loss of appetite that prevents you from eating and causes weight loss;

• confusion, dizziness, fainting, or changes in mental status;

• symptoms of sepsis--fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;

• signs of infection--fever, chills, flu symptoms, cough with mucus, mouth and throat ulcers, feeling short of breath, tingly or painful blistering rash on one side of your body; or

• low sodium level--headache, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of selinexor may include:

• double vision, blurred vision, sensitivity to light or glare;

• tiredness;

• numbness, tingling, or burning pain in your hands or feet;

• anemia, bruising or bleeding;

• increased blood sugar;

• fever, infections, cold or flu symptoms;

• changes in sodium and mineral levels;

• abnormal liver or kidney function tests;

• nausea, vomiting, loss of appetite;

• diarrhea, constipation;

• weight loss; or

• shortness of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect selinexor, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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.