What is XPOVIO (Selinexor)?
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.
What is the most important information I should know about XPOVIO?
XPOVIO can cause serious side effects. These serious side effects include:
- 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.
- 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.
- 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)
- 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.
- XPOVIO may cause fertility problems in males and females, which may affect your ability to have children
- 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
How should I take XPOVIO?
- Take XPOVIO and dexamethasone exactly as prescribed by your healthcare provider.
- Your healthcare provider will tell you how much XPOVIO to take and when to take it. Do not change your dose or stop taking XPOVIO without talking to your healthcare provider first.
- Swallow XPOVIO tablets whole with water. Do not break, chew, crush, or divide the tablets.
- Be sure to take any medicines prescribed by your healthcare provider before and during treatment with XPOVIO to help prevent nausea and vomiting. Tell your healthcare provider if the prescribed medicine does not control your nausea and vomiting.
- It is important for you to drink enough fluids to help prevent dehydration and to eat enough calories to help prevent weight loss during treatment with XPOVIO.
- If you miss a dose of XPOVIO, take your next dose at your next regularly scheduled day and time
- If you vomit after taking a dose of XPOVIO, do not take an extra dose. Take your next dose at your next regularly
Important Safety Information
- Drink enough fluids to help prevent dehydration and to eat enough calories to help prevent weight loss during treatment with XPOVIO.
- Do not change your dose or stop taking XPOVIO without talking to your healthcare provider first.
- 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.
- You should use effective birth control during treatment with XPOVIO and for 1 week after your last dose.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking XPOVIO?
Tell your healthcare provider about all of your medical conditions and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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
- Females who are able to become pregnant
- Females who are breastfeeding or plan to breastfeed
- Males with female partners who are able to become pregnant
General information about XPOVIO
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XPOVIO for a condition for which it was not prescribed. Do not give XPOVIO to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in XPOVIO?
Active ingredient: Selinexor
Inactive ingredient: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.