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What is XPOVIO?

XPOVIO is a prescription medicine, taken along with the medicine dexamethasone, used 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 their disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine. It is not known if XPOVIO is safe and effective in children less than 18 years of age.

IMPORTANT SAFETY INFORMATION

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.

    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 you for side effects. Your healthcare provider may change your dose of XPOVIO, stop your treatment for a period of time, or completely stop your treatment if you have certain side effects during treatment with 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.
  • 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. Your healthcare provider may prescribe medicines that can help increase your appetite or prescribe other kinds of nutritional support.
  • Decreased sodium levels in your blood. Decreased sodium levels in your blood is common with XPOVIO but can also sometimes be severe. You may not have any symptoms. Your healthcare provider may talk with you about your diet and prescribe IV fluids or salt tablets for you based on the sodium levels in your blood.
  • Infections. Infections are common with XPOVIO and can be serious and can sometimes cause death. XPOVIO can cause infections including upper respiratory tract infections, 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 dizziness, fainting, decreased alertness, and changes in your mental status including confusion and decreased awareness of things around you (delirium). These problems can sometimes be severe. Tell your healthcare provider right away if you get any of these signs or symptoms.
  • Do not drive or operate machinery until you know how XPOVIO affects you. XPOVIO may cause dizziness and confusion.

Common side effects of XPOVIO include:

  • tiredness
  • low red blood cell count (anemia). Symptoms may include tiredness and shortness of breath.
  • constipation
  • shortness of breath

These are not all of the possible side effects of XPOVIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my healthcare provider before taking XPOVIO?
Before taking XPOVIO, tell your healthcare provider about all of your medical conditions, including if you:

  • 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.

Reproductive harm. XPOVIO may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

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.

Females who are breastfeeding or plan to breastfeed:

Do not breastfeed during treatment with XPOVIO and for 1 week after your last dose of XPOVIO. It is not known if XPOVIO passes into your breast milk.

Males with female partners who are able to become pregnant should use effective birth control during treatment with XPOVIO and for 1 week after your last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk with your healthcare provider before taking any new medicines.

Please see the Medication Guide in the XPOVIO Full Prescribing Information.