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    Getting patients started on single-agent, oral XPOVIO® (selinexor) for RR DLBCL1

    The recommended dosage of XPOVIO is 60 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity

    Graphic showing the recommended starting dose for treating RR DLBCL with XPOVIO® (selinexor)
      1. Set expectations
    • Counsel patients on what to expect with XPOVIO therapy
      • Advise patients to maintain adequate fluid and caloric intake throughout treatment
      2. Prescribe XPOVIO
    • XPOVIO is a monotherapy taken orally on Days 1 and 3 of each week
    • Administer a 5-HT3 receptor antagonist, such as ondansetron, and other anti-nausea agents,1 such as olanzapine or rolapitant, prior to and during treatment2*
      • The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend olanzapine for the prevention of nausea and vomiting2
      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 IV 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.

    XPOVIO offers patients an effective treatment regimen without the administration of IV chemotherapy, so they can focus on fighting their disease in the comfort of their own homes

    CBC=complete blood count, IV=intravenous.

    In most cases, ARs with XPOVIO were reversible, manageable, and preventable with supportive care and/or dosing adjustments1,3

    Graphic showing dosing modification recommendation
    20 mg pill

    AR=adverse reaction.

    20 mg pill

    AR=adverse reaction.

    • Discontinuation due to ARs occurred in 17% of patients who received XPOVIO
    • ARs which resulted in discontinuation in ≥2% of patients included infection, fatigue, thrombocytopenia, and nausea
    • ARs led to XPOVIO dose interruption in 61% of patients and dose reduction in 49%, with 17% of all patients having ≥2 dose reductions
    • Serious ARs occurred in 46% of patients who received XPOVIO
    • Fatal ARs occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal AR was infection in 4.5% of patients

    Dosage modification guidelines for XPOVIO

    Platelet count 50,000 to <75,000/mcL

    Any occurrence

    • Interrupt 1 dose of XPOVIO
    • Restart XPOVIO at the same dose level

    Platelet count 25,000 to <50,000/mcL without bleeding

    1st occurrence

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

    Platelet count 25,000 to <50,000/mcL with concurrent bleeding

    Any occurrence

    • Interrupt XPOVIO
    • Monitor until platelet count returns to at least 50,000/mcL
    • Restart XPOVIO at 1 dose level lower, after bleeding has resolved
    • Administer platelet transfusions per clinical guidelines

    Platelet count <25,000/mcL

    Any occurrence

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

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

    1st occurrence

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

    Recurrence

    • Interrupt XPOVIO
    • Monitor until neutrophil counts return to ≥1.0 × 109/L or higher
    • Administer growth factors per clinical guidelines
    • Restart XPOVIO at 1 dose level lower

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

    Any occurrence

    • Interrupt XPOVIO
    • Monitor until neutrophil counts return to ≥1.0 × 109/L or higher
    • Administer growth factors per clinical guidelines
    • Restart XPOVIO at 1 dose level lower

    Hemoglobin <8 g/dL

    Any occurrence

    • Reduce XPOVIO by 1 dose level
    • Administer blood transfusions per clinical guidelines

    Life-threatening consequences

    Any occurrence

    • Interrupt XPOVIO
    • Monitor hemoglobin until levels return to 8 g/dL or higher
    • Restart XPOVIO at 1 dose level lower
    • Administer blood transfusions 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 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 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 or baseline
    • Restart XPOVIO at 1 dose level lower

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

    Any occurrence

    • 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 mmol/L

    Any occurrence

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

    Grade 2 lasting >7 days OR Grade 3

    Any occurrence

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

    Grade 2, excluding cataract

    Any occurrence

    • 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

    Any occurrence

    • Permanently discontinue XPOVIO
    • Perform ophthalmologic evaluation

    Cataract (Grade ≥2)

    Any occurrence

    • 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 occurrence

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

    XPOVIO packaging information

    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 for the treatment of RR DLBCL:

    NDC Contents Tablets per blister pack Weekly dose Carton
    NDC 72237-101-03 4 blister packs
    (24 tablets total
    per carton)
    Six 20-mg tablets 60 mg
    twice weekly
    XPOVIO® (selinexor) 60 mg twice weekly dose packaging
    NDC 72237-101-06 4 blister packs
    (16 tablets total
    per carton)
    Four 20-mg tablets 40 mg
    twice weekly
    XPOVIO® (selinexor) 60 mg once weekly dose packaging
    NDC 72237-101-01 4 blister packs
    (12 tablets total
    per carton)
    Three 20-mg tablets 60 mg
    once weekly
    XPOVIO® (selinexor) 40 mg once weekly dose packaging
    NDC 72237-101-07 4 blister packs
    (8 tablets total
    per carton)
    Two 20-mg tablets 40 mg
    once weekly
    XPOVIO® (selinexor) 40 mg twice weekly dose packaging
    XPOVIO® (selinexor) 60 mg twice weekly dose packaging XPOVIO® (selinexor) 40 mg twice weekly dose packaging XPOVIO® (selinexor) 60 mg once weekly dose packaging XPOVIO® (selinexor) 40 mg once weekly dose packaging

    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®): Antiemesis, V.1.2020. © 2020 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed April 2, 2020. 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. 3. Data on file. Karyopharm Therapeutics Inc.

    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.