This Medication Guide has been approved by the U.S. Food and Drug Administration.	Revised: 3/2022
MEDICATION GUIDE XPOVIO® (x-PO-Vee-O) (selinexor) tablets
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 3 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. See “What are the possible side effects of XPOVIO?” for more information about side effects.
What is XPOVIO? XPOVIO is a prescription medicine used: 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
It is not known if XPOVIO is safe and effective in children less than 18 years of age.
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. 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.
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.
How should I take XPOVIO? Take XPOVIO exactly as prescribed by your healthcare provider. If you have multiple myeloma, your healthcare provider will prescribe dexamethasone with your XPOVIO treatment. Take dexamethasone exactly as prescribed. 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. Talk to your healthcare provider if this is a problem for you. See “What are the possible side effects of 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 scheduled day and time. If you take too much XPOVIO, call your healthcare provider right away.
What should I avoid while taking XPOVIO? XPOVIO can cause neurologic side effects. See “What are the possible side effects of XPOVIO?” below. If you have any neurologic side effects with XPOVIO, do not drive or operate heavy or dangerous machinery until your neurologic side effects go away. Avoid falling. Use care as needed to avoid falling due to neurologic side effects.
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.
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.
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 increased blood sugar changes in body salt and mineral levels in your blood changes in kidney and liver function blood tests
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. These are not all 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.
How should I store XPOVIO? Store XPOVIO at or below 86°F (30°C). XPOVIO comes in a child-resistant blister pack.
Keep XPOVIO and all medicines out of the reach of children.
General information about the safe and effective use of 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. You can ask your pharmacist or healthcare provider for information about XPOVIO that is written for health professionals.
What are the ingredients in XPOVIO? Active ingredient: selinexor Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate. Manufactured for and marketed by: Karyopharm Therapeutics Inc., 85 Wells Avenue, Newton, MA, 02459 XPOVIO is a registered trademark of Karyopharm Therapeutics Inc. All other trademarks are the property of their respective owners. ©2022 Karyopharm Therapeutics Inc. For more information, call 1-888-209-9326 or go to www.XPOVIO.com

selinexor

Product monograph

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