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XPOVIO is a brand name for Selinexor, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: XPOVIO® (selinexor) is indicated: • in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Advise patients to maintain adequate fluid and caloric intake throughout treatment. Consider intravenous hydration for patients at risk of dehydration (see 7 WARNINGS AND PRECAUTIONS). • Provide prophylactic antiemetics.
Administer a 5‐HT3 receptor antagonist and other anti‐nausea agents prior to and during treatment with XPOVIO (see 7 WARNINGS AND PRECAUTIONS). 2 Recommended Dose and Dosage Adjustment • The recommended starting dose of XPOVIO in combination with bortezomib and dexamethasone in a 35-day cycle is as follows: o XPOVIO 100 mg (five 20 mg tablets) taken orally once weekly on Day 1 of each week.
3 mg/m2 administered subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off. o dexamethasone 20 mg taken orally twice weekly on Days 1 and 2 of each week. • Treatment is administered until disease progression or unacceptable toxicity.
• For additional information regarding the administration of bortezomib and dexamethasone, refer to their respective Product Monographs. 3 Pharmacokinetics and refer to bortezomib Product Monograph). Table 1 XPOVIO Dosage Reduction Steps for Adverse Reactions Multiple myeloma in combination with bortezomib and dexamethasone (SVd) Recommended starting dosage 100 mg once weekly First reduction 80 mg once weekly Second reduction 60 mg once weekly Third reduction 40 mg once weekly Fourth reduction* Permanently discontinue *If symptoms do not resolve, treatment should be discontinued.
Recommended dosage modifications for hematologic adverse reactions are presented in Table 2. Recommended dosage modifications for non‐hematologic adverse reactions are presented in Table 3. Table 2 XPOVIO Dosage Modification Guidelines for Hematologic Adverse Reactions Adverse Reaction Occurrence Action Thrombocytopenia Platelet count 25 x 109/L to less than 75 x 109/L Any • Reduce XPOVIO by 1 dose level (see Table 1).
Platelet count 25 x 109/L to less than 75 x 109/L with concurrent bleeding Any • Interrupt XPOVIO. • Restart XPOVIO at 1 dose level lower (see Table 1) after bleeding has resolved. • Administer platelet transfusions per clinical guidelines.
Platelet count less than 25 x 109/L Any • Interrupt XPOVIO. • Monitor until platelet count returns to at least 50 x 109/L. • Restart XPOVIO at 1 dose level lower (see Table 1). 5 to 1 x 109/L without fever Any • Reduce XPOVIO by 1 dose level (see Table 1).
and 14 CLINICAL TRIALS). 2 CONTRAINDICATIONS • XPOVIO is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations • Advise patients to maintain adequate fluid and caloric intake throughout treatment. Consider intravenous hydration for patients at risk of dehydration (see 7 WARNINGS AND PRECAUTIONS).
• Provide prophylactic antiemetics. Administer a 5‐HT3 receptor antagonist and other anti‐nausea agents prior to and during treatment with XPOVIO (see 7 WARNINGS AND PRECAUTIONS). 2 Recommended Dose and Dosage Adjustment • The recommended starting dose of XPOVIO in combination with bortezomib and dexamethasone in a 35-day cycle is as follows: o XPOVIO 100 mg (five 20 mg tablets) taken orally once weekly on Day 1 of each week.
3 mg/m2 administered subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off. o dexamethasone 20 mg taken orally twice weekly on Days 1 and 2 of each week. • Treatment is administered until disease progression or unacceptable toxicity.
• For additional information regarding the administration of bortezomib and dexamethasone, refer to their respective Product Monographs. 3 Pharmacokinetics and refer to bortezomib Product Monograph). Table 1 XPOVIO Dosage Reduction Steps for Adverse Reactions Multiple myeloma in combination with bortezomib and dexamethasone (SVd) Recommended starting dosage 100 mg once weekly First reduction 80 mg once weekly Second reduction 60 mg once weekly Third reduction 40 mg once weekly Fourth reduction* Permanently discontinue *If symptoms do not resolve, treatment should be discontinued.
Recommended dosage modifications for hematologic adverse reactions are presented in Table 2. Recommended dosage modifications for non‐hematologic adverse reactions are presented in Table 3. Table 2 XPOVIO Dosage Modification Guidelines for Hematologic Adverse Reactions Adverse Reaction Occurrence Action Thrombocytopenia Platelet count 25 x 109/L to less than 75 x 109/L Any • Reduce XPOVIO by 1 dose level (see Table 1).
, Special Populations, Geriatrics,
• XPOVIO is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 x 109/L OR febrile neutropenia Any • Interrupt XPOVIO. • Monitor until neutrophil counts return to 1 x 109/L or higher. • Restart XPOVIO at 1 dose level lower (see Table 1). XPOVIO® (selinexor) Page 6 of 35 Adverse Reaction Occurrence Action Anemia Hemoglobin less than 80 g/L Any • Reduce XPOVIO by 1 dose level (see Table 1).
• Administer blood transfusions and/or other treatments per clinical guidelines. Life-threatening consequences Any • Interrupt XPOVIO. • Monitor hemoglobin until levels return to 80 g/L or higher. • Restart XPOVIO at 1 dose level lower (see Table 1).
• Administer blood transfusions and/or other treatments per clinical guidelines. Table 3 XPOVIO Dosage Modification Guidelines for Non-Hematologic Adverse Reactions Adverse Reaction Occurrence Action Nausea and Vomiting Grade 1 or 2 nausea (oral intake decreased without significant weight loss, dehydration, or malnutrition) OR Grade 1 or 2 vomiting (5 or fewer episodes per day) Any • Maintain XPOVIO and initiate additional anti-nausea medications.
Grade 3 nausea (inadequate oral caloric or fluid intake) OR Grade 3 or higher vomiting (6 or more episodes per day) Any • Interrupt XPOVIO • Monitor until nausea or vomiting has resolved to Grade 2 or lower or baseline. • Initiate additional anti-nausea medications.
• Restart XPOVIO at 1 dose level lower (see Table 1). Diarrhea Grade 2 (increase of 4 to 6 stools per day over baseline) 1st • Interrupt XPOVIO and institute supportive care. • Monitor until diarrhea resolves to Grade 1 or lower. • Restart XPOVIO at current dose.
2nd and subsequent • Interrupt XPOVIO and institute supportive care. • Monitor until diarrhea resolves to Grade 1 or lower. • Restart XPOVIO at 1 dose level lower (see Table 1). Grade 3 or higher Any • Interrupt XPOVIO and institute supportive care.
XPOVIO® (selinexor) Page 7 of 35 Adverse Reaction Occurrence Action (increase of 7 stools or more per day over baseline; hospitalization indicated) • Monitor until diarrhea resolves to Grade 1 or lower. • Restart XPOVIO at 1 dose level lower (see Table 1).
Weight Loss and Anorexia Weight loss of 10% to less than 20% OR Anorexia associated with significant weight loss or malnutrition Any • Interrupt XPOVIO and institute supportive care. • Monitor until weight returns to more than 90% of baseline weight.
• Restart XPOVIO at 1 dose level lower (see Table 1). Hyponatremia Sodium level 130 – 120 mmol/L Any • Maintain XPOVIO dose and provide appropriate supportive care. • Monitor sodium levels. Sodium level 120 mmol/L or less Any • Interrupt XPOVIO, evaluate, and provide supportive care.
• Monitor until sodium levels return to greater than 130 mmol/L. • Restart XPOVIO at 1 dose level lower (see Table 1). Fatigue Grade 2 lasting greater than 7 days OR Grade 3 1st • Interrupt XPOVIO. • Monitor until fatigue resolves to Grade 1 or baseline.
• Restart XPOVIO at current dose. 2nd and subsequent • Interrupt XPOVIO. • Monitor until fatigue resolves to Grade 1 or baseline. • Restart XPOVIO at 1 dose level lower (see Table 1). Ocular Toxicity§ Grade 2, excluding cataract Any • Perform ophthalmologic evaluation.
• Interrupt XPOVIO and provide supportive care. • Monitor until ocular […]
Platelet count 25 x 109/L to less than 75 x 109/L with concurrent bleeding Any • Interrupt XPOVIO. • Restart XPOVIO at 1 dose level lower (see Table 1) after bleeding has resolved. • Administer platelet transfusions per clinical guidelines.
Platelet count less than 25 x 109/L Any • Interrupt XPOVIO. • Monitor until platelet count returns to at least 50 x 109/L. • Restart XPOVIO at 1 dose level lower (see Table 1). 5 to 1 x 109/L without fever Any • Reduce XPOVIO by 1 dose level (see Table 1).
5 x 109/L OR febrile neutropenia Any • Interrupt XPOVIO. • Monitor until neutrophil counts return to 1 x 109/L or higher. • Restart XPOVIO at 1 dose level lower (see Table 1). XPOVIO® (selinexor) Page 6 of 35 Adverse Reaction Occurrence Action Anemia Hemoglobin less than 80 g/L Any • Reduce XPOVIO by 1 dose level (see Table 1).
• Administer blood transfusions and/or other treatments per clinical guidelines. Life-threatening consequences Any • Interrupt XPOVIO. • Monitor hemoglobin until levels return to 80 g/L or higher. • Restart XPOVIO at 1 dose level lower (see Table 1).
• Administer blood transfusions and/or other treatments per clinical guidelines. Table 3 XPOVIO Dosage Modification Guidelines for Non-Hematologic Adverse Reactions Adverse Reaction Occurrence Action Nausea and Vomiting Grade 1 or 2 nausea (oral intake decreased without significant weight loss, dehydration, or malnutrition) OR Grade 1 or 2 vomiting (5 or fewer episodes per day) Any • Maintain XPOVIO and initiate additional anti-nausea medications.
Grade 3 nausea (inadequate oral caloric or fluid intake) OR Grade 3 or higher vomiting (6 or more episodes per day) Any • Interrupt XPOVIO • Monitor until nausea or vomiting has resolved to Grade 2 or lower or baseline. • Initiate additional anti-nausea medications.
• Restart XPOVIO at 1 dose level lower (see Table 1). Diarrhea Grade 2 (increase of 4 to 6 stools per day over baseline) 1st • Interrupt XPOVIO and institute supportive care. • Monitor until diarrhea resolves to Grade 1 or lower. • Restart XPOVIO at current dose.
2nd and subsequent • Interrupt XPOVIO and institute supportive care. • Monitor until diarrhea resolves to Grade 1 or lower. • Restart XPOVIO at 1 dose level lower (see Table 1). Grade 3 or higher Any • Interrupt XPOVIO and institute supportive care.
XPOVIO® (selinexor) Page 7 of 35 Adverse Reaction Occurrence Action (increase of 7 stools or more per day over baseline; hospitalization indicated) • Monitor until diarrhea resolves to Grade 1 or lower. • Restart XPOVIO at 1 dose level lower (see Table 1).
Weight Loss and Anorexia Weight loss of 10% to less than 20% OR Anorexia associated with significant weight loss or malnutrition Any • Interrupt XPOVIO and institute supportive care. • Monitor until weight returns to more than 90% of baseline weight.
• Restart XPOVIO at 1 dose level lower (see Table 1). Hyponatremia Sodium level 130 – 120 mmol/L Any • Maintain XPOVIO dose and provide appropriate supportive care. • Monitor sodium levels. Sodium level 120 mmol/L or less Any • Interrupt XPOVIO, evaluate, and provide supportive care.
• Monitor until sodium levels return to greater than 130 mmol/L. • Restart XPOVIO at 1 dose level lower (see Table 1). Fatigue Grade 2 lasting greater than 7 days OR Grade 3 1st • Interrupt XPOVIO. • Monitor until fatigue resolves to Grade 1 or baseline.
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