Xpovio 40 mg once-weekly is used together with bortezomib and/or dexamethasone to treat multiple myeloma in adults.

Xpovio 40 mg once-weekly is also used in adults to treat certain types of diffuse large B-cell lymphoma.

Xpovio 40 mg once-weekly is given after other medications did not work or have stopped working.

Xpovio 40 mg once-weekly was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to Xpovio 40 mg once-weekly, but further studies are needed.

Xpovio 40 mg once-weekly 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,

Xpovio 40 mg once-weekly 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 Xpovio 40 mg once-weekly 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.

Xpovio 40 mg once-weekly 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 this medicine with dexamethasone and/or bortezomib.

Your doctor will determine how long to treat you with Xpovio 40 mg once-weekly and dexamethasone.

Take Xpovio 40 mg once-weekly with a full glass of water. Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking Xpovio 40 mg once-weekly, 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.

Xpovio 40 mg once-weekly 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 this medicine.

Store at room temperature away from moisture and heat. Keep each Xpovio 40 mg once-weekly tablet in the blister pack until you are ready to take your dose.

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 Xpovio 40 mg once-weekly should use effective birth control to prevent pregnancy. Xpovio 40 mg once-weekly 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 Xpovio 40 mg once-weekly.

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 Xpovio 40 mg once-weekly 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.

Avoid driving or hazardous activity until you know how Xpovio 40 mg once-weekly 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.

Xpovio 40 mg once-weekly 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.

Xpovio 40 mg once-weekly 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 Xpovio 40 mg once-weekly 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 Xpovio 40 mg once-weekly, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.