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- Prescribing Information
This site is intended for US healthcare professionals only.
Oral, once-weekly XPOVIO dosing may be adjusted to help mitigate potential ARs with XVd1
Recommended XPOVIO dose reduction steps1
65% (126/195) of patients in the XVd arm of the XVd trial had an XPOVIO dose reduction2
80 mg (range, 30-137 mg) taken once weekly was the median dosage of XPOVIO in the XVd arm1
Please see full Prescribing Information for specific dose modification guidelines as they pertain to individual ARs.
XPOVIO dose reduction: incidence of duration-adjusted ARs3*
Adverse reactions (%)
On or before first XPOVIO dose reduction (n=195)
After first XPOVIO dose reduction (n=126)
All grades
Grade ≥3
All grades
Grade ≥3
Thrombocytopenia
62.5
29.6
47.6
19.2
Nausea
31.6
3.9
7.3
2.7
Fatigue
28.1
4.1
9.9
2.7
Decreased appetite
21.5
1.6
6.4
0.4
Anemia
17.9
4.7
10.3
3.2
Diarrhea
12.9
2.0
5.2
0.7
Neutropenia
10.6
4.0
7.7
4.8
Weight decreased
9.0
0.6
5.9
0.7
*Duration-adjusted incidence of ARs is defined as the average number of events per 100 patients during a 4-week cycle.
Efficacy maintained in patients with XPOVIO dose reduction to help mitigate potential ARs
mPFS in dose-reduced patient population1-3
Limitations of subgroup analysis:
- This subgroup analysis was exploratory in nature and not a study objective
- This subgroup analysis was underpowered to detect clinically meaningful differences in treatment effect
- This subgroup analysis was intended to provide information about dose modifications and not to compare efficacy across treatment groups
Abbreviations: AR, adverse reaction; ITT, intent to treat; IV, intravenous; mPFS, median progression-free survival; NE, not evaluable; Vd, bortezomib and dexamethasone; XVd, selinexor, bortezomib, and dexamethasone.
References: 1. XPOVIO (selinexor) [prescribing information]. Newton, MA. Karyopharm Therapeutics, Inc. 2. Data on file. Karyopharm Therapeutics Inc. 2021. 3. Jagannath S, Facon T, Badros AZ, et al. Clinical outcomes in patients with dose reduction of selinexor in combination with bortezomib, and dexamethasone (XVd) in previously treated multiple myeloma from the BOSTON study. Poster presented at: 63rd ASH Annual Meeting and Exposition; December 13, 2021; Atlanta, GA.
INDICATION
XPOVIO® (selinexor) is a prescription medicine approved in combination with bortezomib and dexamethasone (XVd) to treat adult patients with multiple myeloma who have received at least one prior therapy.
IMPORTANT SAFETY INFORMATION
Thrombocytopenia: XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia was reported in patients with multiple myeloma.
Thrombocytopenia is the leading cause of dosage modifications. Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Monitor patients for signs and symptoms of bleeding. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.
Neutropenia: XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection.
Monitor more frequently during the first 3 months of treatment. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.
Gastrointestinal Toxicity: XPOVIO can cause severe gastrointestinal toxicities in patients.
Nausea/Vomiting/Diarrhea: Provide prophylactic antiemetics or treatment as needed.
Anorexia/Weight Loss: Monitor weight, nutritional status, and volume status at baseline and throughout treatment and provide nutritional support, fluids, and electrolyte repletion as clinically indicated.
Hyponatremia: XPOVIO can cause severe or life-threatening hyponatremia.
Monitor sodium level at baseline and throughout treatment.
Serious Infection: XPOVIO can cause serious and fatal infections. Atypical infections reported after taking XPOVIO include, but are not limited to, fungal pneumonia and herpesvirus infection.
Neurological Toxicity: XPOVIO can cause life-threatening neurological toxicities.
Coadministration of XPOVIO with other products that cause dizziness or mental status changes may increase the risk of neurological toxicity.
Advise patients to refrain from driving and engaging in hazardous occupations or activities, until the neurological toxicity fully resolves. Institute fall precautions as appropriate.
Embryo-Fetal Toxicity: XPOVIO can cause fetal harm when administered to a pregnant woman.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.
Cataracts: New onset or exacerbation of cataract has occurred during treatment with XPOVIO. The incidence of new onset or worsening cataract requiring clinical intervention was reported.
ADVERSE REACTIONS
The most common adverse reactions (ARs) (≥20%) in patients with multiple myeloma who received XVd were fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract, and vomiting.
Grade 3-4 laboratory abnormalities (≥10%) were thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia.
Fatal ARs occurred in 6% of patients within 30 days of last treatment. Serious ARs occurred in 52% of patients. Treatment discontinuation rate due to ARs was 19%. The most frequent ARs requiring permanent discontinuation in >2% of patients included fatigue, nausea, thrombocytopenia, decreased appetite, peripheral neuropathy and vomiting. Adverse reactions led to XPOVIO dose interruption in 83% of patients and dose reduction in 64% of patients.
USE IN SPECIFIC POPULATIONS
No overall difference in effectiveness of XPOVIO was observed in patients >65 years old when compared with younger patients. Patients ≥65 years old had a higher incidence of discontinuation due to an adverse reaction (AR) and a higher incidence of serious ARs than younger patients.
The effect of end-stage renal disease (CLCR <15 mL/min) or hemodialysis on XPOVIO pharmacokinetics is unknown.
Please see full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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