XPOVIO® (selinexor) | Side Effects of XPOVIO® (selinexor) for RR DLBCL

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What are the possible side ef‌fects with XPOVIO^® (selinexor)?

Serious side ef‌fects

Low platelet counts
Low white blood cell counts
Nausea and vomiting
Diarrhea
Loss of appetite and weight loss
Decreased sodium levels in your blood
Infections
Neurologic side ef‌fects

Common side ef‌fects

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 the possible side ef‌fects of XPOVIO.

Call your healthcare provider for medical advice about side ef‌fects.
You may report side ef‌fects to the FDA at 1-800-FDA-10881-800-FDA-1088 or fda.gov/medwatch

In the clinical trial, the amount of time patients took XPOVIO ranged
from 1 to 193 weeks, with the median amount of time being 9 weeks

Support Starts Here

The XPOVIO Patient Education Starter Kit has helpful information about treatment as well as tips for living well with relapsed
or refractory dif‌fuse large B-cell lymphoma (RR DLBCL).

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Clinical Trial

See how patients responded to treatment during the trial

Review Results

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Taking XPOVIO

See the recommended dosing schedule

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What is XPOVIO?

XPOVIO^® (selinexor) is a prescription medicine used:

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 (refractory) to at least 2 proteasome inhibitor medicines, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine

What is the most important information I should know about XPOVIO?

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.

What is XPOVIO?

XPOVIO^® (selinexor) is a prescription medicine used:

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 (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

XPOVIO is approved based on patient response rate. There are ongoing studies to confirm the clinical benefit of XPOVIO for these uses.

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?

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.

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, or may prescribe certain medicines to help increase your white blood cell count.
Nausea and vomiting and/or diarrhea. Nausea and vomiting and/or diarrhea can occur when you take XPOVIO and can sometimes be severe. You may be at risk for becoming dehydrated and may need treatments. Your healthcare provider may prescribe anti-nausea or anti-diarrhea medicines for you to take before you start and during treatment with XPOVIO.
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 are losing weight. Your healthcare provider may prescribe medicines or advise on nutritional support.
Decreased sodium levels in your blood. Decreased sodium levels in your blood are common with XPOVIO and 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.
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 confusion and decreased awareness of things around you. XPOVIO may also cause problems with thinking (cognitive problems), seeing or hearing things that are not really there (hallucinations), and may cause you to become very sleepy or drowsy. 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. XPOVIO may cause dizziness and confusion. Take precautions to prevent a fall.

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 for XPOVIO. See full Prescribing Information.

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.