Dosing &
Management

Getting patients started on XPOVIO®

Once-weekly XPOVIO® dosing

Recommended starting dosage and schedule

  • The recommended starting dose of XPOVIO® in combination with bortezomib and dexamethasone in a 35-day cycle is as follows:
    • XPOVIO® 100 mg (five 20 mg tablets) taken orally once weekly on Day 1 of each week.
    • bortezomib 1.3 mg/m2 administered subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off.
    • dexamethasone 20 mg taken orally twice weekly on Days 1 and 2 of each week.
  • Treatment is administered until disease progression or unacceptable toxicity.

Dosing considerations

Advise patients to maintain adequate fluid and caloric intake throughout treatment.

Consider intravenous hydration for patients at risk of dehydration.

Provide prophylactic antiemetics. Administer a 5-HT3 receptor antagonist and other anti-nausea agents prior to and during treatment with XPOVIO®.

Administration

Each XPOVIO® dose should be taken orally at approximately the same time of day.

Each tablet should be swallowed whole with water.

Do not break, chew, crush, or divide the tablets.

XPOVIO® can be taken with or without food.

Missed Dose

If an XPOVIO® dose is missed or delayed or a patient vomits after a dose of XPOVIO®, the patient should not repeat the dose. Patients should take the next dose on the next regularly scheduled day.

Monitoring and managing XPOVIO®1

XPOVIO® dosage modification

General XPOVIO® dosage reduction steps

Table with general XPOVIO® dosage reduction steps Enlarge Image

* If symptoms do not resolve, treatment should be discontinued.

For hematologic adverse reactions

Adverse Reaction

Occurrence

Action

Platelet count 25 x 109/L to less than 75 x 109/L

Any

  • Reduce XPOVIO® by 1 dose level.

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 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.

Absolute neutrophil count of 0.5 to 1 x 109/L without fever

Any

  • Reduce XPOVIO® by 1 dose level.

Absolute neutrophil count of less than 0.5 x 109/L
OR
febrile neutropenia

Any

  • Interrupt XPOVIO®.
  • Monitor until neutrophil count returns to 1 x 109/L or higher.
  • Restart XPOVIO® at 1 dose level lower.

Hemoglobin less than 80 g/L

Any

  • Reduce XPOVIO® by 1 dose level.
  • 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.
  • Administer blood transfusions and/or other treatments per clinical guidelines.

For non-hematologic adverse reactions

Adverse Reaction

Occurrence

Action

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.

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.

Grade 3 or higher (increase of 7 stools or more per day over baseline; hospitalization indicated)

Any

  • Interrupt XPOVIO® and institute supportive care.
  • Monitor until diarrhea resolves to Grade 1 or lower.
  • Restart XPOVIO® at 1 dose level lower.

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.

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.

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.

Grade 2, excluding cataract

Any

  • Perform ophthalmologic evaluation.
  • Interrupt XPOVIO® and provide supportive care.
  • Monitor until ocular symptoms resolve to Grade 1 or baseline.
  • Restart XPOVIO® at 1 dose level lower.

Grade ≥ 3, excluding cataract

Any

  • Permanently discontinue XPOVIO®
  • Perform ophthalmologic evaluation.

Cataract (Grade ≥ 2)

Any

  • Perform ophthalmologic evaluation.
  • Reduce XPOVIO® by 1 dose level.
  • Monitor for progression.
  • Hold XPOVIO® dose 24 hours prior to surgery and for 72 hours after surgery.

Grade 3 or 4

Any

  • Interrupt XPOVIO®.
  • Monitor until resolved to Grade 2 or lower, restart XPOVIO® at 1 dose level lower.

* Ocular toxicities may include blindness, cataracts, visual acuity reduced, vision blurred, and visual impairment.

Managing transient, treatment-related nausea

Provide prophylactic antiemetics.1 Administer a 5-HT3 receptor antagonist and other anti-nausea agents prior to and during treatment with XPOVIO®.1

Ondansetron
8 mg orally 30 to 60 minutes prior to each dose and continued every 8 hours for 2 days following dosing2,3

+

Olanzapine
2.5 mg–5.0 mg orally every bedtime2,4

and/or

Aprepitant
125 mg orally each morning on day 1 and 80 mg for 2 days each week2,5,6

  • Alternatively, once-weekly oral dose of Akynzeo® (netupitant 300 mg + palonosetron 0.5 mg).7,8
  • One or both antiemetics may be tapered after 6-8 weeks.5
  • Advise patients to maintain adequate fluid and caloric intake.5

Please see the XPOVIO® Product Monograph for complete dosing and administration information.

For additional information regarding the dosing and administration of bortezomib, dexamethasone, ondansetron, aprepitant, netupitant, and palonosetron, refer to their respective Product Monographs. Olanzapine is not indicated for the treatment of nausea associated with cancer therapy.

Dosing and Dose Modification Guide

Dosing and Dose Modification Guide

Dosing and Dose Modification Guide

A guide to initiating, monitoring, and modifying XPOVIO® treatment in patients.

Download PDF

Feeling well, doing well: Optimizing outcomes through effective patient management

Feeling well, doing well: Optimizing outcomes through effective patient management

Feeling well, doing well: Optimizing outcomes through effective patient management

A guide for managing transient, treatment-related nausea.

Download PDF

† Using dexamethasone together with aprepitant or Akynzeo® may increase the effects of dexamethasone. If using aprepitant or Akynzeo®, the dose of dexamethasone may need to be reduced.6,7

AEs, adverse events.

References
1. FORUS Therapeutics Inc. XPOVIO® (selinexor tablets) Product Monograph. March 22, 2024.
2. Gavriatopoulou M, et al. Integrated safety profile of selinexor in multiple myeloma. Leukemia. 2020;34(9):2430-2440.
3. Novartis Pharmaceuticals Canada Inc. ZOFRAN® (ondansetron) Product Monograph. November 9, 2021.
4. Mylan Pharmaceuticals. MYLAN-OLANZAPINE (olanzapine) Product Monograph. March 19, 2020.
5. Mikhael J, et al. Consensus recommendations for the clinical management of patients with multiple myeloma treated with selinexor. Clin Lymphoma Myeloma Leuk. 2020;20(6):351-357.
6. Merck Canada Inc. EMEND® (aprepitant) Product Monograph. January 22, 2014.
7. Knight Therapeutics Inc. AKYNZEO® (netupitant and palonosetron) Product Monograph. November 15, 2022.
8. Magen H, et al. Selinexor, bortezomib, and dexamethasone for heavily pretreated multiple myeloma: a case series. Clin Lymphoma Myeloma Leuk. 2020;20(12):e947-e955.