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    In adult patients with RR DLBCL who have received ≥2 prior therapies,

    Adverse reactions with oral XPOVIO® (selinexor)1,2

    Adverse reactions (ARs) ≥10% in RR DLBCL (N=134)


    Adverse Reactions All grades
    (%)
    Grade ≥3
    (%)
    Grade 3
    (%)
    Grade 4
    (%)
    General Conditions
    Fatiguea 63 15 15 0
    Pyrexia 22 4.5 4.5 0
    Edemab 17 2.2 1.5 0.7
    Gastrointestinal
    Nausea 57 6 6 0
    Diarrheac 37 3 3 0
    Constipation 37 3 3 0
    Constipation 29 0 0 0
    Vomiting 28 1.5 1.5 0
    Abdominal paind 10 0 0 0

    aFatigue includes fatigue and asthenia.

    bEdema includes edema, swelling, swelling face, edema peripheral, peripheral swelling, acute pulmonary edema.

    cDiarrhea includes diarrhea, post-procedural diarrhea, gastroenteritis.

    dAbdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, epigastric discomfort.

    eAppetite decrease includes decreased appetite and hypophagia.

    fCough includes cough and productive cough.

    gDyspnea includes dyspnea and dyspnea exertional.

    hUpper respiratory tract infection includes upper respiratory tract infection, sinusitis, nasopharyngitis, pharyngitis, rhinitis, viral upper respiratory infection.

    iUrinary tract infection includes urinary tract infection and specific types of urinary tract infection.

    jDizziness includes dizziness and vertigo.

    kTaste disorder includes taste disorder, dysgeusia, ageusia.

    lMental status changes include confusional state, amnesia, cognitive disorder, hallucination, delirium, somnolence, depressed level of consciousness, memory impairment.

    mPeripheral neuropathy includes peripheral neuropathy, peripheral sensory neuropathy, sensory disturbance, paresthesia, neuralgia.

    nMusculoskeletal pain includes musculoskeletal pain, back pain, musculoskeletal chest pain, neck pain, pain in extremity, bone pain.

    oHemorrhage includes hemorrhage, hematoma, hematuria, epistaxis, rectal hemorrhage, injection site hematoma, subdural hematoma, upper gastrointestinal hemorrhage, corneal bleeding.

    pVision blurred includes vision blurred, visual acuity reduced, visual impairment.

    Adverse Reactions All grades
    (%)
    Grade ≥3
    (%)
    Grade 3
    (%)
    Grade 4
    (%)
    Metabolism and Nutrition
    Appetite decreasee 37 3.7 3.7 0
    Weight decrease 30 0 0 0
    Respiratory
    Coughf 18 0 0 0
    Dyspneag 10 1.5 0.75 0.75
    Infections
    Upper respiratory tract infectionh 17 1.5 1.5 0
    Pneumonia 10 6 6 0
    Urinary tract infectioni 10 3 3 0
    Adverse Reactions All grades
    (%)
    Grade ≥3
    (%)
    Grade 3
    (%)
    Grade 4
    (%)
    Nervous System
    Dizzinessj 16 0.7 0.7 0
    Taste disorderk 13 0 0 0
    Mental status changesl 11 3.7 3 0.7
    Peripheral neuropathy, sensorym 10 0 0 0
    Musculoskeletal
    Musculoskeletal painn 15 2.2 2.2 0
    Vascular
    Hypotension 13 3 3 0
    Hemorrhageo 10 0.7 0.7 0
    Eye Disorders
    Vision blurredp 11 0.7 0.7 0

    aFatigue includes fatigue and asthenia.

    bEdema includes edema, swelling, swelling face, edema peripheral, peripheral swelling, acute pulmonary edema.

    cDiarrhea includes diarrhea, post-procedural diarrhea, gastroenteritis.

    dAbdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, epigastric discomfort.

    eAppetite decrease includes decreased appetite and hypophagia.

    fCough includes cough and productive cough.

    gDyspnea includes dyspnea and dyspnea exertional.

    hUpper respiratory tract infection includes upper respiratory tract infection, sinusitis, nasopharyngitis, pharyngitis, rhinitis, viral upper respiratory infection.

    iUrinary tract infection includes urinary tract infection and specific types of urinary tract infection.

    jDizziness includes dizziness and vertigo.

    kTaste disorder includes taste disorder, dysgeusia, ageusia.

    lMental status changes include confusional state, amnesia, cognitive disorder, hallucination, delirium, somnolence, depressed level of consciousness, memory impairment.

    mPeripheral neuropathy includes peripheral neuropathy, peripheral sensory neuropathy, sensory disturbance, paresthesia, neuralgia.

    nMusculoskeletal pain includes musculoskeletal pain, back pain, musculoskeletal chest pain, neck pain, pain in extremity, bone pain.

    oHemorrhage includes hemorrhage, hematoma, hematuria, epistaxis, rectal hemorrhage, injection site hematoma, subdural hematoma, upper gastrointestinal hemorrhage, corneal bleeding.

    pVision blurred includes vision blurred, visual acuity reduced, visual impairment.

    Clinically relevant ARs in <10% of patients who received XPOVIO included:

    • Injury: fall (8%)
    • Metabolic and nutrition disorders: dehydration (7%)
    • Neurologic disorders: headache (4.5%), syncope (2.2%)
    • Infection: sepsis (6%), herpesvirus infection (3%)
    • Eye disorders: cataract (3.7%)
    • Blood and lymphatic disorders: febrile neutropenia (3%)
    • Cardiac disorders: cardiac failure (3%)

    Laboratory abnormalities with oral XPOVIO1,2

    Laboratory abnormalities worsening from baseline ≥15% in RR DLBCL (N=134)


    Laboratory Abnormality All grades
    (%)
    Grade ≥3
    (%)
    Grade 3
    (%)
    Grade 4
    (%)
    Hematologic
    Platelet count decrease 86 49 31 18
    Hemoglobin decrease 82 25 25 0
    Lymphocyte count decrease 63 37 32 5
    Neutrophil count decrease 58 31 21 10
    Chemistry
    Sodium decrease 62 16 16 0
    Glucose increasea 57a 5 3 2
    Creatinine increase 47 3.9 1.6 2.3
    Phosphate decrease 34 11 10 1
    Magnesium decrease 30 2.6 0.8 1.8
    Calcium decrease 30 0.9 0.9 0
    Potassium increase 26 3.9 3.1 0.8
    Potassium decrease 23 7 6 1
    CK increaseb 21 1.9 1.9 0
    Laboratory Abnormality All grades
    (%)
    Grade ≥3
    (%)
    Grade 3
    (%)
    Grade 4
    (%)
    Hepatic
    ALT increase 29 0.8 0 0.8
    Albumin decrease 25 0 0 0
    AST increase 24 3.1 2.3 0.8
    Bilirubin increase 16 1.6 1.6 0

    The denominator used to calculate the rate varied from 107 to 128 based on the number of patients with at least one post-treatment value.

    aNot fasting.

    bCK increase was not associated with reports of myopathy or myalgia.

    ALT=alanine aminotransferase, AST=aspartate aminotransferase, CK=creatine kinase.

    To learn more about doses and dose modifications for XPOVIO,
    download the Getting Started Guide

    Download

    References: 1. XPOVIO (selinexor) [package insert]. Newton, MA: Karyopharm Therapeutics Inc.; June 2020. 2. 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.