What is XPOVIO?
XPOVIO® (selinexor) is a prescription medicine used:
- in combination with bortezomib and dexamethasone to treat adults with multiple myeloma who have received at least one prior therapy.
- in combination with dexamethasone to treat adults with multiple myeloma 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 (refractory) to at least 2 proteasome inhibitor medicines, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine
XPOVIO is approved based on patient response rate. There are ongoing studies to confirm the clinical benefit of XPOVIO for the following use:
- to treat adults with certain types of diffuse large B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory) and who have received at least 2 prior systemic therapies.
It is not known if XPOVIO is safe and effective in children less than 18 years of age.
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.
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. If needed, your healthcare provider may prescribe antibiotics if you have signs or symptoms of infection.
Serious infections. Infections are common with XPOVIO and can be serious and can sometimes cause death. This includes 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 dizziness, fainting, decreased alertness, and changes in your mental status, including problems with thinking, seeing or hearing things that are not really there (hallucinations). These problems can sometimes be severe and life-threatening. Tell your healthcare provider right away if you get any of these symptoms. Do not drive or operate heavy or dangerous machinery until you know how XPOVIO affects you. Take precautions to prevent a fall.
Nausea, vomiting and/or diarrhea. Nausea, vomiting and/or diarrhea can occur when you take XPOVIO and can sometimes be severe. You may be at risk for becoming dehydrated. Your healthcare provider may prescribe anti-nausea or anti-diarrhea medicines.
Loss of appetite and weight loss. Loss of appetite and weight loss are common with XPOVIO. Tell your healthcare provider if you have a decrease or loss of appetite and if you are losing weight.
Decreased sodium levels in your blood. Decreased sodium levels in your blood are common with XPOVIO. Your healthcare provider may talk with you about your diet and prescribe IV fluids or salt tablets.
New or worsening cataract, cloudiness 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, or sensitivity to light or glare.
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
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 the FDA at 1-800-FDA-10881-800-FDA-1088.
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
- are taking prescription and over-the-counter medicines, vitamins, and herbal supplements
Ability to have children: XPOVIO may affect the ability of both women and men 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, as XPOVIO can harm an unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with XPOVIO. 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.
Please see the Medication Guide and the full Prescribing Information for XPOVIO.
To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-93261-888-209-9326 or FDA at 1-800-FDA-10881-800-FDA-1088 or www.fda.gov/medwatch.
