Xpovio
Pronunciation: x-PO-Vee-O
Generic name: selinexor
Dosage form: oral tablet (20 mg, 40 mg, 50 mg, 60 mg)
Drug class: Miscellaneous antineoplastics
What is Xpovio?
Xpovio (selinexor) is used to treat multiple myeloma (MM) or relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in adults. Xpovio is an oral tablet that is taken 1 to 2 times a week.
Xpovio gained FDA approval on July 3, 2019. There is no generic.
FDA approvals
Xpovio is a prescription medicine used:
- in combination with Velcade (bortezomib) and dexamethasone to treat adults with multiple myeloma (MM) who have received at least 1 prior treatment for their disease
- in combination with dexamethasone to treat adults with 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 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
Note that the approval for DLBCL is under the accelerated approval designation. Continued approval for this indication may be contingent upon a clinical benefit being shown in further clinical trials.
It is not known if Xpovio is safe and effective in children less than 18 years of age.
Is Xpovio a chemo drug?
No, Xpovio is not a chemotherapy drug it is a targeted treatment that works in a novel way to enhance your body's cancer defence mechanisms.
Clinical trials have shown that because Xpovio is a targeted treatment it has a more focused effect on cancer cells while minimizing damage to healthy cells. Xpovio is often used in combination with other medicines to enhance its effectiveness.
How does Xpovio work?
Xpovio’s mechanism of action involves targeting a specific protein complex called XPO1, which is responsible for removing tumor suppressor proteins out of the cell nucleus. This leads to the accumulation of XPO1 inside the cell, which reinitiates and amplifies its function, leading to apoptosis (cell death) of cancer cells, while largely sparing normal cells.
Xpovio belongs to the drug class called selective inhibitors of nuclear export (SINE). It was the first in its class to be developed.
Xpovio side effects
The most common side effects of Xpovio are:
- tiredness
- low red blood cell count (anemia)
- 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.
Serious side effects and warnings
Xpovio can cause the following serious side effects.
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.
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.
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, 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, or sensitivity to light or glare.
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 some time, or completely stop your treatment if you have certain side effects during treatment with Xpovio.
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 the FDA at 1-800-FDA-1088.
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Before taking
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
- are breastfeeding or plan to breastfeed.
Pregnancy
Xpovio can harm your unborn baby. Females who can 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 can become pregnant:
- You should use effective birth control during treatment with Xpovio and for 1 week after your last dose.
Breastfeeding
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.
How should I take Xpovio?
Take Xpovio exactly as prescribed by your healthcare provider.
- Xpovio is usually taken 1 or 2 times a week depending on what type of cancer you have or what other treatments you take with this medicine.
- If you have multiple myeloma, your healthcare provider will prescribe dexamethasone and sometimes bortezomib 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.
Xpovio may make you feel sick (nauseous) and you may vomit.
- Be sure to take medicines to help prevent nausea and vomiting that have been prescribed by your healthcare provider before and during treatment with Xpovio.
- Tell your healthcare provider if the prescribed medicine does not control your nausea and vomiting.
- Drink enough fluids to help prevent dehydration and eat enough calories to help prevent weight loss during treatment with Xpovio. Talk to your healthcare provider if this is a problem for you.
Dosing information
Dosage for Multiple Myeloma in combination with bortezomib and dexamethasone (XVd):
- Xpovio 100 mg once weekly in combination with bortezomib and dexamethasone.
Dosage for Multiple Myeloma in combination with dexamethasone (Xd):
- Xpovio 80 mg on Days 1 and 3 of each week (2 times weekly) in combination with dexamethasone.
Dosage for DLBCL:
- Xpovio 60 mg on Days 1 and 3 of each week (2 times weekly).
What happens if I miss a dose?
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.
What happens if I overdose?
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. If you feel sleepy, dizzy or have any other 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 other drugs will affect 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 store Xpovio?
Store Xpovio tablets at or below 86°F (30°C) in its original child-resistant blister pack.
Keep out of the reach of children
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.
Who makes Xpovio?
Xpovio is manufactured by Karyopharm Therapeutics Inc whose headquarters are in Massachusetts. The company was founded in 2008 and focuses on improving the lives of patients with cancer.
Xpovio is their lead compound.
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- Drug class: miscellaneous antineoplastics
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.