Selinexor

What is Selinexor?

• Selinexor (Xpovio) is a nuclear export inhibitor used in the treatment of multiple myeloma and Diffuse large B-cell lymphoma (certain types).

Selinexor

What are the uses of this medicine?

Selinexor (Xpovio) is used:

• in combination with the medicines VELCADE® (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.

• 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.

How does this medicine work?

• Selinexor is an orally available, small molecule inhibitor of CRM1 (chromosome region maintenance 1 protein, exportin 1 or XPO1), with potential antineoplastic activity.
• Selinexor modifies the essential CRM1-cargo binding residue cysteine-528, thereby irreversibly inactivating CRM1-mediated nuclear export of cargo proteins such as tumor suppressor proteins (TSPs), including p53, p21, BRCA1/2, pRB, FOXO, and other growth regulatory proteins.
• As a result, this agent, via the approach of selective inhibition of nuclear export (SINE), restores endogenous tumor suppressing processes to selectively eliminate tumor cells while sparing normal cells.
• CRM1, the major export factor for proteins from the nucleus to the cytoplasm, is overexpressed in a variety of cancer cell types.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Selinexor was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in July 2019, for use in combination with the corticosteroid dexamethasone.
• In December 2020, selinexor was approved by the FDA in combination with bortezomib and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy.

How should this medicine be used?

Recommended dosage: Multiple Myeloma in Combination with Bortezomib and Dexamethasone (XVd):

• Recommended dosage of Xpovio is 100 mg taken orally once weekly in combination with bortezomib and dexamethasone.

Multiple Myeloma in Combination with Dexamethasone (Xd):

• Recommended dosage of Xpovio is 80 mg taken orally on Days 1 and 3 of each week in combination with dexamethasone.

Recommended Dosage for Diffuse Large B-Cell Lymphoma:

• The recommended dosage of Xpovio is 60 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity.

Administration:

• Swallow Xpovio tablets whole with water. Do not break, chew, crush, or divide the tablets.
• Be sure to take any medicines prescribed by your healthcare provider before and during treatment with Xpovio to help prevent 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.
• If you have multiple myeloma, your healthcare provider will prescribe dexamethasone with your Xpovio treatment. Take dexamethasone exactly as prescribed.
• 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 are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 20 mg, 40 mg, 50 mg, 60 mg

This medicine is available in fallowing brand namesː

• Xpovio

What side effects can this medication cause?

The most common side effects of this medicine 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

Xpovio may cause fertility problems in males and females, which may affect your ability to have children.

Xpovio can cause serious side effects, including:

• Low platelet counts
• Low white blood cell counts
• Nausea and vomiting
• Diarrhea
• Loss of appetite and weight loss
• Decreased sodium levels in your blood
• Serious infections
• Neurologic side effects
• New or worsening cataract

What special precautions should I follow?

• Xpovio can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
• Xpovio can cause life-threatening neutropenia, potentially increasing the risk of infection. Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony-stimulating factors.
• Xpovio can cause severe gastrointestinal toxicities. Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
• Xpovio can cause severe or life-threatening hyponatremia. Monitor serum sodium levels throughout treatment.
• Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
• Xpovio can cause serious and fatal infections. Monitor for infection and treat promptly.
• Xpovio can cause life-threatening neurological toxicities. Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
• Xpovio can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
• New onset or exacerbation of cataract has occurred during treatment with Xpovio. Treatment of cataracts usually requires surgical removal of the cataract.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings in animal studies and its mechanism of action, Xpovio can cause fetal harm when administered to a pregnant woman.
• There are no available data in pregnant women to inform the drug-associated risk.
• Advise pregnant women of the risks to a fetus.

Can this medicine be used in children?

• It is not known if Xpovio is safe and effective in children less than 18 years of age.

What are the active and inactive ingredients in this medicine?

• 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 manufactures and distributes this medicine?

Manufactured for and marketed by:

• Karyopharm Therapeutics Inc., 85 Wells Avenue, Newton, MA

• Xpovio is a registered trademark of Karyopharm Therapeutics Inc.

What should I know about storage and disposal of this medication?

• Store Xpovio at or below 86°F (30°C).
• Xpovio comes in a child-resistant blister pack.

• Dailymed label info on Selinexor
• FDA Selinexor

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