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    Recommended dosage and schedule for XPOVIO® (selinexor)1

    The recommended dosage for relapsed or refractory multiple myeloma (RRMM) patients on XPOVIO is 80 mg (four 20-mg tablets) taken with dexamethasone 20 mg

    Chart showing the recommended dosing schedule for XPOVIO® (selinexor) Chart showing the recommended dosing schedule for XPOVIO® (selinexor)

    XPOVIO has no known contraindications.

    Patients should take 5-HT3 antagonists and/or other anti-nausea agents
    prior to and during treatment with XPOVIO

    Three key steps to starting your patients on XPOVIO2

      1. Set expectations
    • Counsel patients on what to expect when receiving treatment with XPOVIO + dexamethasone
      • Advise patients to maintain adequate fluid and caloric intake throughout treatment
      2. Prescribe XPOVIO
    • XPOVIO is taken orally on Days 1 and 3 of each week in combination with dexamethasone
    • Administer a 5-HT3 receptor antagonist, such as ondansetron, and other anti-nausea agents, such as olanzapine or rolapitant, prior to and during treatment*
      • The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends olanzapine for the prevention of nausea and vomiting*
      3. Monitor your patient
    • Monitor CBC with differential, standard blood chemistries, body weight, nutritional status, and volume status at baseline and during treatment, more frequently during the first 3 months of treatment
    • Consider intravenous hydration for patients at risk of dehydration
    • Assess the need for dose modifications (see table below)

    *Please see prescribing information for dosage and administration of agents listed.

    For additional information regarding the administration of dexamethasone, refer to its prescribing information.

    Monitoring, managing, and modifying for adverse reactions (ARs) is an integral part of XPOVIO treatment in RRMM

    Chart showing monitoring, managing and modifying XPOVIO® (selinexor) dose for adverse reactions, over four weeks Chart showing monitoring, managing and modifying XPOVIO® (selinexor) dose for adverse reactions, over four weeks

    Reduction or interruption of XPOVIO dose occurred in 53% and 65.3% of patients, respectively.

    Getting patients started on XPOVIO

    How to Take XPOVIO

    Calendar icon

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

    Water icon

    Each tablet should be swallowed whole with water

    Warning icon

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

    Time icon

    If a dose of XPOVIO is missed or delayed, instruct
    patients to take their next dose at the next regularly
    scheduled time

    Next day icon

    If a patient vomits a dose of XPOVIO, the patient should
    not repeat the dose and the patient should take the next
    dose on the next regularly scheduled day

    Recommended Monitoring for Safety

    Baseline icon

    Monitor at baseline and during treatment as clinically indicated

    • Complete blood count (CBC) with differential
    • Standard blood chemistry
    • Body weight
    3 months icon

    Monitor more frequently during the first 3 months of treatment

    Apple icon

    Advise patients to maintain adequate fluid and caloric
    intake throughout treatment

    Intravenous hydration icon

    Consider intravenous hydration for patients at risk of dehydration

    Nausea icon

    Provide prophylactic concomitant treatment with a
    5-HT3 antagonist and/or other anti-nausea agents prior
    to and during treatment with XPOVIO

    Dosage modification guidelines for XPOVIO

    Platelet count 25,000 to <75,000/mcL

    • Reduce XPOVIO by 1 dose level

    Platelet count 25,000 to <75,000/mcL with concurrent bleeding

    • Interrupt XPOVIO
    • Restart XPOVIO at 1 dose level lower, after bleeding has resolved
    • Administer platelet transfusions per clinical guidelines

    Platelet count <25,000/mcL

    • Interrupt XPOVIO
    • Monitor until platelet count returns to at least 50,000/mcL
    • Restart XPOVIO at 1 dose level lower

    Absolute neutrophil count of 0.5 to 1.0 × 109/L without fever

    • Reduce XPOVIO by 1 dose level

    Absolute neutrophil count <0.5 × 109/L OR febrile neutropenia

    • Interrupt XPOVIO
    • Monitor until neutrophil counts return to 1.0 × 109/L or higher
    • Restart XPOVIO at 1 dose level lower

    Hemoglobin <8.0 g/dL

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

    Life-threatening consequences (urgent intervention indicated)

    • Interrupt XPOVIO
    • Monitor hemoglobin until levels return to 8 g/dL or higher
    • Restart XPOVIO at 1 dose level lower
    • Administer blood transfusions and/or other treatments per clinical guidelines

    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 occurrence

    • 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 occurrence

    • 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 occurrence

    • Maintain XPOVIO and institute supportive care

    2nd and subsequent occurrences

    • Reduce XPOVIO by 1 dose level
    • Institute supportive care

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

    Any occurrence

    • Interrupt XPOVIO and institute supportive care
    • Monitor until diarrhea resolves to Grade 2 or lower
    • Restart XPOVIO at 1 dose level lower

    Grade 2 lasting >7 days OR Grade 3

    • Interrupt XPOVIO
    • Monitor until fatigue resolves to Grade 1 or baseline
    • Restart XPOVIO at 1 dose level lower

    Weight loss of 10% to <20% OR anorexia associated with significant weight loss or malnutrition

    • Interrupt XPOVIO and institute supportive care
    • Monitor until weight returns to >90% of baseline weight
    • Restart XPOVIO at 1 dose level lower

    Sodium level 130 mmol/L or less

    • Interrupt XPOVIO and provide appropriate supportive care
    • Monitor until sodium levels return to 130 mmol/L or higher
    • Restart XPOVIO at 1 dose level lower

    Grade 2, excluding cataract

    • Perform ophthalmologic evaluation
    • Interrupt XPOVIO and provide supportive care
    • Monitor until ocular symptoms resolve to Grade 1 or baseline

    Grade 1 or baseline

    • Restart XPOVIO at 1 dose level lower

    Grade ≥3

    • Permanently discontinue XPOVIO
    • Perform ophthalmologic evaluation

    Cataract (Grade ≥2)

    • 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 (life-threatening)

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

    How supplied

    XPOVIO are blue, round, bi-convex, and film-coated 20-mg tablets with “K20” debossed on one side and nothing on the other side.

    • Tablets are packaged in a child-resistant blister pack
    • 4 blister packs are supplied per carton

    The following 4 dose presentations are available:

    Carton

    NDC

    Contents

    Tablets Per Blister Pack

    Weekly Dose

    Carton

    XPOVIO® (selinexor) 80 mg twice weekly dose packaging

    NDC

    Outer carton:
    NDC 72237-101-04

    Contents

    4 blister packs
    (32 tablets total in the carton)

    Tablets Per Blister Pack

    Eight 20-mg tablets

    Weekly Dose

    80 mg twice weekly

    Carton

    XPOVIO® (selinexor) 100 mg once weekly dose packaging

    NDC

    Outer carton:
    NDC 72237-101-05

    Contents

    4 blister packs
    (20 tablets total in the carton)

    Tablets Per Blister Pack

    Five 20-mg tablets

    Weekly Dose

    100 mg once weekly

    Carton

    XPOVIO® (selinexor) 80 mg once weekly dose packaging

    NDC

    Outer carton:
    NDC 72237-101-02

    Contents

    4 blister packs
    (16 tablets total in the carton)

    Tablets Per Blister Pack

    Four 20-mg tablets

    Weekly Dose

    80 mg once weekly

    Carton

    XPOVIO® (selinexor) 60 mg once weekly dose packaging

    NDC

    Outer carton:
    NDC 72237-101-01

    Contents

    4 blister packs
    (12 tablets total in the carton)

    Tablets Per Blister Pack

    Three 20-mg tablets

    Weekly Dose

    60 mg once weekly

    XPOVIO can be accessed through authorized specialty pharmacies and specialty distributors

    Learn More

    References: 1. XPOVIO (selinexor) [package insert]. Newton, MA: Karyopharm Therapeutics Inc.; June 2020. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma. V.2.2020. © 2020 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed November 15, 2019. To view the most recent and complete version of the NCCN Guidelines, 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.

    INDICATIONS

    • XPOVIO® (selinexor) in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody.
    • XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

    IMPORTANT SAFETY INFORMATION

    Thrombocytopenia: XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia was reported in patients with multiple myeloma (MM) and developed or worsened in patients with DLBCL.

    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. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.