What is the most important information I should know about XPOVIO?
XPOVIO can cause serious side effects, including:

• Low platelet counts. Low platelet counts are common with XPOVIO and can lead to bleeding which can be severe and can sometimes cause death. Your healthcare provider may prescribe platelet transfusions or other treatments for your low platelet counts.
  Tell your healthcare provider right away if you have any bleeding or easy bruising during treatment with XPOVIO.
• Low white blood cell counts. Low white blood cell counts are common with XPOVIO and can sometimes be severe. You may have an increased risk of getting bacterial infections during treatment with XPOVIO. Your healthcare provider may prescribe antibiotics if you have signs or symptoms of infection, or certain medicines to help increase your white blood cell count, if needed.

• in combination with the medicines VELCADE® (bortezomib) and dexamethasone to treat adults with multiple myeloma (MM) who have received at least one prior treatment for their disease.
• in combination with dexamethasone to treat adults with multiple myeloma (MM) that has come back (relapsed) or that did not respond to previous treatment (refractory), and
  • who have received at least 4 prior therapies, and
  • whose disease did not respond to (refractory) to at least 2 proteasome inhibitor medicines, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine.
• to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory) and who have received at least 2 prior therapies
  

• have or have had a recent or active infection
• have or have had bleeding problems
• are pregnant or plan to become pregnant. XPOVIO can harm your unborn baby.
  Females who are able to become pregnant:
  • Your healthcare provider will check to see if you are pregnant before you start taking XPOVIO.
  • You should use effective birth control (contraception) during treatment with XPOVIO and for 1 week after your last dose.
  • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with XPOVIO.

  Males with female partners who are able to become pregnant:

  • You should use effective birth control during treatment with XPOVIO and for 1 week after your last dose.
• are breastfeeding or plan to breastfeed. It is not known if XPOVIO passes into your breast milk.
  • Do not breastfeed during treatment with XPOVIO and for 1 week after your last dose of XPOVIO.

What are the possible side effects of XPOVIO?
XPOVIO can cause serious side effects, including:

• See “What is the most important information I should know about XPOVIO?”
• Nausea and vomiting. Nausea and vomiting are common with XPOVIO and can sometimes be severe. Nausea and vomiting may affect your ability to eat and drink well. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive intravenous (IV) fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-nausea medicines for you to take before you start and during treatment with XPOVIO. See “How should I take XPOVIO?”
• Diarrhea. Diarrhea is common with XPOVIO and can sometimes be severe. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive IV fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-diarrhea medicine for you as needed.
• Loss of appetite and weight loss. Loss of appetite and weight loss are common with XPOVIO and can sometimes be severe. Tell your healthcare provider if you have a decrease or loss of appetite and if you notice that you are losing weight at any time during treatment. Your healthcare provider may prescribe medicines that can help increase your appetite or prescribe other kinds of nutritional support. Your healthcare provider will monitor your appetite and weight before you start XPOVIO and often during the first 3 months, then as needed during treatment.
• Decreased sodium levels in your blood. Decreased sodium levels in your blood is common with XPOVIO but can also sometimes be severe. Low sodium levels in your blood can happen if you have nausea, vomiting, or diarrhea, you become dehydrated, or if you have loss of appetite with XPOVIO. You may not have any symptoms of a low sodium level. Your healthcare provider may talk with you about your diet and prescribe IV fluids for you based on the sodium levels in your blood. Your healthcare provider will do blood tests before you start taking XPOVIO, and often during the first 2 months of treatment, and then as needed during treatment to monitor the sodium levels in your blood.
• Serious infections. Infections are common with XPOVIO and can be serious and can sometimes cause death. XPOVIO can cause infections including upper or lower respiratory tract infections, such as pneumonia, and an infection throughout your body (sepsis). Tell your healthcare provider right away if you have any signs or symptoms of an infection such as cough, chills or fever, during treatment with XPOVIO.
• Neurologic side effects. XPOVIO can cause neurologic side effects that can sometimes be severe and life- threatening.
  • XPOVIO can cause dizziness, fainting, decreased alertness, and changes in your mental status including confusion and decreased awareness of things around you (delirium).
  • In some people, XPOVIO may also cause problems with thinking (cognitive problems), seeing or hearing things that are not really there (hallucinations), and may become very sleepy or drowsy.
  • Taking other medicines that can cause dizziness or mental status changes during treatment with XPOVIO may increase your risk of neurologic side effects.

  Tell your healthcare provider right away if you get any of these signs or symptoms.

• New or worsening cataract, a cloudy or loss of transparency of the lens in the eye. New or worsening cataract are common with XPOVIO. If a cataract forms, your vision may decrease, and you may need eye surgery to remove the cataract and restore your vision. Tell your healthcare provider right away if you have symptoms of a cataract such as double vision, blurred vision, sensitivity to light or glare.

• tiredness
• low red blood cell count (anemia). Symptoms may include tiredness and shortness of breath.
• constipation
• shortness of breath
• increased blood sugar
• changes in body salt and mineral levels in your blood
• changes in kidney and liver function blood tests

• Store XPOVIO at or below 86°F (30°C).
• XPOVIO comes in a child-resistant blister pack.