Selinexor: Difference between revisions
(Created page with "{{DrugProjectFormSinglePage |authorTag=Omid Afkhami Ardakani |genericName=Selinexor |aOrAn=a |drugClass=Selective Inhibitor of Nuclear Export (SINE) |indicationType=treatment |indication=Relapsed or Refractory Multiple Myeloma (RRMM), Diffuse Large B-Cell Lymphoma (DLBCL) |hasBlackBoxWarning=Yes |adverseReactions=Nausea, fatigue, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, weight loss |blackBoxWarningTitle=Serious Hematologic a...") |
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|drugClass=Selective Inhibitor of Nuclear Export (SINE) | |drugClass=Selective Inhibitor of Nuclear Export (SINE) | ||
|indicationType=treatment | |indicationType=treatment | ||
|indication=Relapsed or Refractory Multiple Myeloma (RRMM), Diffuse Large B-Cell Lymphoma (DLBCL) | |indication=Relapsed or Refractory Multiple Myeloma (RRMM), and Diffuse Large B-Cell Lymphoma (DLBCL) | ||
|hasBlackBoxWarning=Yes | |hasBlackBoxWarning=Yes | ||
|adverseReactions=Nausea, fatigue, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, weight loss | |adverseReactions=Nausea, fatigue, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, and weight loss | ||
|blackBoxWarningTitle=Serious Hematologic and Gastrointestinal Toxicities | |blackBoxWarningTitle=Serious Hematologic and Gastrointestinal Toxicities | ||
|blackBoxWarningBody=The use of selinexor is associated with severe risks, such as thrombocytopenia, neutropenia, gastrointestinal side effects like nausea and vomiting, and hyponatremia. Frequent monitoring is required during treatment, particularly within the first three months | |blackBoxWarningBody=The use of selinexor is associated with severe risks, such as thrombocytopenia, neutropenia, gastrointestinal side effects like nausea and vomiting, and hyponatremia. Frequent monitoring is required during treatment, particularly within the first three months | ||
|fdaLIADAdult=For Multiple Myeloma: In combination with dexamethasone, the recommended dose is 80 mg orally on Days 1 and 3 of each week. In combination with bortezomib and dexamethasone, the dose is 100 mg orally once weekly on Day 1 | |fdaLIADAdult=For Multiple Myeloma: In combination with dexamethasone, the recommended dose is 80 mg orally on Days 1 and 3 of each week. In combination with bortezomib and dexamethasone, the dose is 100 mg orally once weekly on Day 1. | ||
For DLBCL:The recommended dose is 60 mg orally on Days 1 and 3 of each week | For DLBCL:The recommended dose is 60 mg orally on Days 1 and 3 of each week. | ||
|contraindications=Severe thrombocytopenia | |contraindications=Severe thrombocytopenia | ||
Uncontrolled infections or serious hematologic conditions | Uncontrolled infections or serious hematologic conditions | ||
| Line 17: | Line 17: | ||
Neutropenia: Increases the risk of infection; regular white blood cell counts are recommended. | Neutropenia: Increases the risk of infection; regular white blood cell counts are recommended. | ||
Gastrointestinal Toxicity: Selinexor can cause severe nausea and vomiting; antiemetic therapy is advised. | Gastrointestinal Toxicity: Selinexor can cause severe nausea and vomiting; antiemetic therapy is advised. | ||
Hyponatremia: Risk of low sodium levels, which may not present with specific symptoms; sodium levels should be monitored | Hyponatremia: Risk of low sodium levels, which may not present with specific symptoms; sodium levels should be monitored. | ||
|clinicalTrials=Nausea (65%) | |clinicalTrials=Nausea (65%) | ||
Fatigue (59%) | Fatigue (59%) | ||
| Line 23: | Line 23: | ||
Weight loss (29%) | Weight loss (29%) | ||
Severe laboratory abnormalities: Thrombocytopenia, neutropenia, and anemia | Severe laboratory abnormalities: Thrombocytopenia, neutropenia, and anemia | ||
|postmarketing=Postmarketing surveillance has reported adverse reactions consistent with those observed in clinical trials, emphasizing the importance of monitoring for hematologic toxicity | |postmarketing=Postmarketing surveillance has reported adverse reactions consistent with those observed in clinical trials, emphasizing the importance of monitoring for hematologic toxicity. | ||
|drugInteractions=anticoagulants | |drugInteractions=anticoagulants | ||
NSAIDs | NSAIDs | ||
|useInPregnancyFDA=Not recommended during pregnancy | |useInPregnancyFDA=Not recommended during pregnancy. | ||
|useInNursing=Breastfeeding is not recommended while on selinexor | |useInNursing=Breastfeeding is not recommended while on selinexor. | ||
|administration=Selinexor is administered orally, and patients are advised to take the tablet whole with water. Do not crush, chew, or break the tablet. It is essential to maintain adequate hydration and caloric intake during treatment | |administration=Selinexor is administered orally, and patients are advised to take the tablet whole with water. Do not crush, chew, or break the tablet. It is essential to maintain adequate hydration and caloric intake during treatment | ||
|monitoring=Frequent monitoring of platelet count, neutrophil levels, body weight, and sodium levels is recommended, especially in the first three months of treatment | |monitoring=Frequent monitoring of platelet count, neutrophil levels, body weight, and sodium levels is recommended, especially in the first three months of treatment. | ||
|IVCompat=Not applicable as selinexor is administered orally only | |IVCompat=Not applicable as selinexor is administered orally only. | ||
|overdose=Symptoms of overdose include severe hematologic and gastrointestinal toxicity. Supportive care and monitoring of vital signs are necessary. Dose adjustments may be required based on the severity of adverse effects | |overdose=Symptoms of overdose include severe hematologic and gastrointestinal toxicity. Supportive care and monitoring of vital signs are necessary. Dose adjustments may be required based on the severity of adverse effects. | ||
|mechAction=Selinexor inhibits XPO1, leading to the accumulation of tumor suppressor proteins in the nucleus, promoting cancer cell apoptosis. This mechanism is effective against multiple myeloma and DLBCL | |mechAction=Selinexor inhibits XPO1, leading to the accumulation of tumor suppressor proteins in the nucleus, promoting cancer cell apoptosis. This mechanism is effective against multiple myeloma and DLBCL. | ||
|PD=Selinexor's activity correlates with its ability to inhibit XPO1, resulting in growth inhibition of tumor cells. | |PD=Selinexor's activity correlates with its ability to inhibit XPO1, resulting in growth inhibition of tumor cells. | ||
|PK=After oral administration, selinexor reaches peak plasma concentration in approximately 4 hours. It is metabolized primarily via proteolysis, and its half-life is around 6 hours | |PK=After oral administration, selinexor reaches peak plasma concentration in approximately 4 hours. It is metabolized primarily via proteolysis, and its half-life is around 6 hours. | ||
|howSupplied=Selinexor is available as film-coated tablets in various strengths (20 mg, 40 mg, 50 mg, and 60 mg). It is supplied in blister packs, which are child-resistant | |howSupplied=Selinexor is available as film-coated tablets in various strengths (20 mg, 40 mg, 50 mg, and 60 mg). It is supplied in blister packs, which are child-resistant. | ||
|storage=Selinexor should be stored at or below 30°C (86°F) and kept in its original packaging to protect from moisture | |storage=Selinexor should be stored at or below 30°C (86°F) and kept in its original packaging to protect from moisture. | ||
|alcohol=Alcohol may exacerbate gastrointestinal symptoms such as nausea. Patients are advised to limit alcohol consumption during treatment | |alcohol=Alcohol may exacerbate gastrointestinal symptoms such as nausea. Patients are advised to limit alcohol consumption during treatment | ||
|brandNames=Xpovio is the primary brand name for selinexor | |brandNames=Xpovio is the primary brand name for selinexor | ||
}} | }} | ||
Latest revision as of 21:39, 25 October 2024
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami Ardakani
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Black Box Warning
|
Serious Hematologic and Gastrointestinal Toxicities
See full prescribing information for complete Boxed Warning.
The use of selinexor is associated with severe risks, such as thrombocytopenia, neutropenia, gastrointestinal side effects like nausea and vomiting, and hyponatremia. Frequent monitoring is required during treatment, particularly within the first three months
|
Overview
Selinexor is a Selective Inhibitor of Nuclear Export (SINE) that is FDA approved for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM), and Diffuse Large B-Cell Lymphoma (DLBCL). There is a Black Box Warning for this drug as shown here. Common adverse reactions include Nausea, fatigue, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, and weight loss.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
For Multiple Myeloma: In combination with dexamethasone, the recommended dose is 80 mg orally on Days 1 and 3 of each week. In combination with bortezomib and dexamethasone, the dose is 100 mg orally once weekly on Day 1. For DLBCL:The recommended dose is 60 mg orally on Days 1 and 3 of each week.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Selinexor FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
Severe thrombocytopenia Uncontrolled infections or serious hematologic conditions
Warnings
|
Serious Hematologic and Gastrointestinal Toxicities
See full prescribing information for complete Boxed Warning.
The use of selinexor is associated with severe risks, such as thrombocytopenia, neutropenia, gastrointestinal side effects like nausea and vomiting, and hyponatremia. Frequent monitoring is required during treatment, particularly within the first three months
|
Thrombocytopenia: Frequent platelet monitoring is advised due to risk of severe bleeding. Neutropenia: Increases the risk of infection; regular white blood cell counts are recommended. Gastrointestinal Toxicity: Selinexor can cause severe nausea and vomiting; antiemetic therapy is advised. Hyponatremia: Risk of low sodium levels, which may not present with specific symptoms; sodium levels should be monitored.
Adverse Reactions
Clinical Trials Experience
Nausea (65%) Fatigue (59%) Diarrhea (40%) Weight loss (29%) Severe laboratory abnormalities: Thrombocytopenia, neutropenia, and anemia
Postmarketing Experience
Postmarketing surveillance has reported adverse reactions consistent with those observed in clinical trials, emphasizing the importance of monitoring for hematologic toxicity.
Drug Interactions
anticoagulants NSAIDs
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Not recommended during pregnancy.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Selinexor in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Selinexor during labor and delivery.
Nursing Mothers
Breastfeeding is not recommended while on selinexor.
Pediatric Use
There is no FDA guidance on the use of Selinexor in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Selinexor in geriatric settings.
Gender
There is no FDA guidance on the use of Selinexor with respect to specific gender populations.
Race
There is no FDA guidance on the use of Selinexor with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Selinexor in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Selinexor in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Selinexor in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Selinexor in patients who are immunocompromised.
Administration and Monitoring
Administration
Selinexor is administered orally, and patients are advised to take the tablet whole with water. Do not crush, chew, or break the tablet. It is essential to maintain adequate hydration and caloric intake during treatment
Monitoring
Frequent monitoring of platelet count, neutrophil levels, body weight, and sodium levels is recommended, especially in the first three months of treatment.
IV Compatibility
Not applicable as selinexor is administered orally only.
Overdosage
Symptoms of overdose include severe hematologic and gastrointestinal toxicity. Supportive care and monitoring of vital signs are necessary. Dose adjustments may be required based on the severity of adverse effects.
Pharmacology
There is limited information regarding Selinexor Pharmacology in the drug label.
Mechanism of Action
Selinexor inhibits XPO1, leading to the accumulation of tumor suppressor proteins in the nucleus, promoting cancer cell apoptosis. This mechanism is effective against multiple myeloma and DLBCL.
Structure
There is limited information regarding Selinexor Structure in the drug label.
Pharmacodynamics
Selinexor's activity correlates with its ability to inhibit XPO1, resulting in growth inhibition of tumor cells.
Pharmacokinetics
After oral administration, selinexor reaches peak plasma concentration in approximately 4 hours. It is metabolized primarily via proteolysis, and its half-life is around 6 hours.
Nonclinical Toxicology
There is limited information regarding Selinexor Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Selinexor Clinical Studies in the drug label.
How Supplied
Selinexor is available as film-coated tablets in various strengths (20 mg, 40 mg, 50 mg, and 60 mg). It is supplied in blister packs, which are child-resistant.
Storage
Selinexor should be stored at or below 30°C (86°F) and kept in its original packaging to protect from moisture.
Images
Drug Images
{{#ask: Page Name::Selinexor |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Selinexor |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Selinexor Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol may exacerbate gastrointestinal symptoms such as nausea. Patients are advised to limit alcohol consumption during treatment
Brand Names
Xpovio is the primary brand name for selinexor
Look-Alike Drug Names
There is limited information regarding Selinexor Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.