Selinexor

What it is used for

XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

1.1 Multiple Myeloma XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

The most important thing to know

XPOVIO can cause serious side effects, including: Low platelet counts and low white blood cell counts are common with XPOVIO and can sometimes be severe or life-threatening. Low platelet counts. Low platelet counts can lead to bleeding which 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. You may have an increased risk of infection during treatment with XPOVIO. Tell your healthcare provider if you have any signs or symptoms of infection, including fever, chills, cough, shortness of breath, pain during urination, or feeling generally unwell.

Your healthcare provider may prescribe antibiotics, 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 your blood cell counts.

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How to take it

Take XPOVIO exactly as prescribed by your healthcare provider. Do not change your dose or stop taking XPOVIO without talking to your healthcare provider first. If you have multiple myeloma, your healthcare provider will prescribe dexamethasone with your XPOVIO treatment. Take dexamethasone exactly as prescribed. Swallow XPOVIO tablets whole with water.

Do not break, chew, crush, or divide the tablets. Take any medicines your healthcare provider prescribes before and during treatment with XPOVIO to help prevent nausea and vomiting. Tell your healthcare provider if the prescribed medicine does not help 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,

Side effects, and when to stop

” for more information about side effects. What is XPOVIO? XPOVIO is a prescription medicine used: in combination with the medicines 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.

It is not known if XPOVIO is safe and effective in children. 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 have or have had liver problems have cataracts 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 (contraception) 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.

Who should not take it

do not take an extra dose. Take your next dose at your next regularly scheduled day and time.

What to avoid

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: Stomach and intestinal (gastrointestinal) problems are common with XPOVIO and can sometimes be severe. Nausea and vomiting. 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. 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. 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 or life-threatening. 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. XPOVIO can cause infections that can sometimes cause death, 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.

Talk to your healthcare provider about all of your medicines. 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 visi

Storing it

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.