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- Prescribing Information
This site is intended for US healthcare professionals only.
After a relapse on an anti-CD38 mAb-based regimen in RRMM...
target progression.
Differently.1
After a relapse on an anti-CD38 mAb-based regimen in RRMM...
target progression.
Differently.1
XPOVIO provides the opportunity to:
Introduce a different treatment class1
Deliver proven efficacy* in combination with Vd, with efficacy observed across a variety of patient subgroups1,2
Offer oral, once-weekly tablets that can be taken at home1†
Administer treatment and monitor patients without required hospitalization1
*XVd vs Vd trial: Phase 3, global, open-label study of adult patients with MM who received 1 to 3 prior therapies that compared XVd with Vd in 402 patients randomized into 2 study arms. 195 patients were treated with once-weekly XVd and twice-weekly dexamethasone. 207 patients were treated with twice-weekly bortezomib and 4-times-weekly dexamethasone. The primary endpoint was PFS, and select secondary endpoints included ORR and DOR. The XVd mPFS of the ITT population was 13.9 months vs a Vd mPFS of 9.5 months (HR, 0.70 [95% CI, 0.53-0.9]; P=.0075).1
†XPOVIO is a prescription medicine approved in combination with subcutaneous bortezomib injection and oral dexamethasone.
Oral, once-weekly selinexor (XPOVIO) in combination with bortezomib and dexamethasone (XVd) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred NCCN Category 1 therapeutic option in previously treated (1-3 prior therapies), lenalidomide-refractory MM.3‡
Understand the Need
Unmet Need
In MM, outcomes are poor for patients who are recycled on an anti-CD38 mAb.4
Explore the Data
XVd Trial Results
See the PFS benefit of XPOVIO + Vd compared to Vd, including how certain subgroups responded.
See Your Next Steps
Starting XPOVIO
Get patients started with XPOVIO + Vd by setting expectations, proactively managing ARs, and assessing for dose modifications.
Discover Support
Patient Support
Enroll your patients in KaryForward®, the support program dedicated to helping them start and stay on XPOVIO + Vd.
‡Category 1=Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.2.2024. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed November 9, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
XPOVIO: The fastest growing brand in 3L MM in 20235§
§Based on IntrisiQ® claims analysis comparing US XPOVIO market share in new patients vs available brands approved in 3L MM in FY 2023.
Abbreviations: 3L, third line; AR, adverse reaction; CI, confidence interval; DOR, duration of response; FY, fiscal year; HR, hazard ratio; ITT, intent-to-treat; mAb, monoclonal antibody; MM, multiple myeloma; mPFS, median progression-free survival; ORR, overall response rate; PFS, progression-free survival; RRMM, relapsed or refractory multiple myeloma; Vd, bortezomib and dexamethasone; XVd, selinexor, bortezomib, and dexamethasone.
NCCN, National Comprehensive Cancer Network® (NCCN®).
References: 1. XPOVIO (selinexor) [prescribing information]. Newton, MA. Karyopharm Therapeutics, Inc. 2. Data on file [1]. Karyopharm Therapeutics Inc. 2023. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.2.2024. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed November 9, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. 4. Mikhael J, Belhadj-Merzoug K, Hulin C, et al. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab. Blood Cancer J. 2021;11(5):89. doi:10.1038/s41408-021-00478-4 5. Data on file [2]. Karyopharm Therapeutics Inc. 2023.
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.
© 2023 Karyopharm Therapeutics Inc.
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