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The first and only FDA-approved oral medicine of its kind
XPOVIO was studied in 122 adults with relapsed refractory multiple myeloma who were treated with XPOVIO 80 mg + dexamethasone 20 mg on Days 1 and 3 of every week. The approval of XPOVIO was based upon results in a subgroup of 83 people whose disease no longer responded to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab.
Call your healthcare provider for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Get information about treatment with 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.
What is the most important information I should know about XPOVIO?
XPOVIO can cause serious side effects, including:
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.
Common side effects of XPOVIO include:
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:
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.