Xpovio

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 4/7/2022
Xpovio Side Effects Center

What Is Xpovio?

Xpovio (selinexor) is a nuclear export inhibitor indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

What Are Side Effects of Xpovio?

Common side effects of Xpovio include:

  • low blood platelets,
  • fatigue,
  • nausea,
  • anemia,
  • decreased appetite,
  • weight loss,
  • diarrhea,
  • vomiting,
  • low blood sodium,
  • low white blood cell counts,
  • constipation,
  • shortness of breath, and
  • upper respiratory tract infection

Dosage for Xpovio

The recommended starting dose of Xpovio is 80 mg in combination with dexamethasone taken orally on days 1 and 3 of each week.

What Drugs, Substances, or Supplements Interact with Xpovio?

Xpovio may interact with other drugs. Tell your doctor all medications and supplements you use.

Xpovio During Pregnancy and Breastfeeding

Xpovio is not recommended for use during pregnancy; it may harm a fetus. Females of reproductive potential are advised to use effective contraception during treatment with Xpovio and for one week after the last dose. It is unknown if Xpovio passes into breast milk. Because of the potential for serious adverse reactions in a nursing child, breastfeeding is not recommended while using Xpovio and for at least one week after the last dose.

Additional Information

Our Xpovio (selinexor) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Xpovio Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Selinexor can cause serious or fatal side effects. Some side effects may not occur until you have been taking this medicine for several days or weeks.

Call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • severe ongoing nausea, vomiting, or diarrhea;
  • loss of appetite that prevents you from eating and causes weight loss;
  • confusion, dizziness, fainting, or changes in mental status;
  • symptoms of sepsis--fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
  • signs of infection--fever, chills, flu symptoms, cough with mucus, mouth and throat ulcers, feeling short of breath, tingly or painful blistering rash on one side of your body; or
  • low sodium level--headache, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • double vision, blurred vision, sensitivity to light or glare;
  • tiredness;
  • numbness, tingling, or burning pain in your hands or feet;
  • anemia, bruising or bleeding;
  • increased blood sugar;
  • fever, infections, cold or flu symptoms;
  • changes in sodium and mineral levels;
  • abnormal liver or kidney function tests;
  • nausea, vomiting, loss of appetite;
  • diarrhea, constipation;
  • weight loss; or
  • shortness of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xpovio (Selinexor Tablets)

Xpovio Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described in detail in other labeling sections:

  • Thrombocytopenia [see WARNINGS AND PRECAUTIONS].
  • Neutropenia [see WARNINGS AND PRECAUTIONS].
  • Gastrointestinal Toxicity [see WARNINGS AND PRECAUTIONS].
  • Hyponatremia [see WARNINGS AND PRECAUTIONS].
  • Serious Infection [see WARNINGS AND PRECAUTIONS].
  • Neurological Toxicity [see WARNINGS AND PRECAUTIONS].
  • Cataract [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Multiple Myeloma

XPOVIO in Combination with Bortezomib and Dexamethasone (SVd)

The safety of XPOVIO in combination with bortezomib and dexamethasone was evaluated in BOSTON [see Clinical Studies]. Patients were randomized to receive XPOVIO 100 mg orally once weekly in combination with bortezomib and dexamethasone (SVd) (n=195) or bortezomib and dexamethasone (Vd) (n=204). Among patients who received XPOVIO, the median duration of XPOVIO treatment was 29 weeks (range: 1 to 120 weeks) and the median dose was 80 mg (range: 30 to 137 mg) per week.

Serious adverse reactions occurred in 52% of patients who received XPOVIO in combination with bortezomib and dexamethasone. Serious adverse reactions in >3% of patients included pneumonia (14%), sepsis, diarrhea and vomiting (4% each). Fatal adverse reactions occurred in 6% of patients within 30 days of last treatment, including pneumonia (n=3) and sepsis (n=3).

Grade ≥2 peripheral neuropathy, a pre-specified key secondary endpoint, was lower in the SVd arm (21%) compared to the Vd arm (34%); odds ratio 0.50 [95% CI: 0.32, 0.79]. The median treatment duration was 30 weeks (range: 1-120 weeks) in patients who received once weekly SVd as compared to 32 weeks (range: 1-122 weeks) in patients who received twice weekly Vd.

Permanent discontinuation of XPOVIO due to an adverse reaction occurred in 19% of patients. Adverse reactions which resulted in permanent discontinuation of XPOVIO in >2% of patients included fatigue (3.6%), nausea (3.1%), thrombocytopenia, decreased appetite, peripheral neuropathy and vomiting (2.1% each).

Dosage interruptions of XPOVIO due to an adverse reaction occurred in 83% of patients. Adverse reactions which required dosage interruption in >5% of patients included thrombocytopenia (33%), fatigue (13%), asthenia (12%), pneumonia (11%), upper respiratory tract infection (10%), decreased appetite (9%), neutropenia (8%), pyrexia (8%), nausea (7%), bronchitis (7%), diarrhea (6%), weight decreased (6%) and anemia (5%).

Dose reductions of XPOVIO due to an adverse reaction occurred in 64% of patients. Adverse reactions which required dose reductions in >5% of patients included thrombocytopenia (31%), decreased appetite (8%), nausea, fatigue, decreased weight (7% each) and asthenia (6%).

The most common adverse reactions (≥20% with a difference between arms of >5% compared to Vd) were fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, weight decrease, cataract, and vomiting. Grade 3-4 laboratory abnormalities (≥10%) were thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia.

Table 5 summarizes the adverse reactions in BOSTON.

Table 5: Adverse Reactions (≥10%) in Patients with Multiple Myeloma Who Received XPOVIO in Combination with Bortezomib and Dexamethasone (SVd) with a Difference Between Arms of >5% Compared to Vd in BOSTON

Adverse ReactionWeekly SVd
(n=195)
Twice Weekly Vd
(n=204)
All Grades
(%)
Grade 3 or 4
(%)
All Grades
(%)
Grade 3 or 4
(%)
Gastrointestinal
  Nausea508100
  Diarrhea32625<1
  Vomiting214.14.40
General Conditions
  Fatiguea5928215
  Pyrexia151.5111
Metabolism and Nutrition
  Appetite decrease353.650
  Weight decrease262.1121
Nervous System
  Peripheral neuropathyb324.6479
  Dizziness12<13.90
Infections
  Upper respiratory tract infectionc293.6221.5
Eye Disorders
  Cataract22961.5
  Vision blurredd12<160
Key: S=selinexor, Vd=bortezomib-dexamethasone
a. Fatigue includes fatigue and asthenia.
b. Peripheral neuropathy includes neuropathy peripheral, peripheral sensory neuropathy, polyneuropathy, peripheral sensorimotor neuropathy, toxic neuropathy and peripheral motor neuropathy.
c. Upper respiratory tract infection includes upper respiratory infection, nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, and viral upper respiratory tract infection.
d. Vision blurred includes blurred vision, visual acuity reduced and visual impairment.

Clinically relevant adverse reactions in <10% of patients who received XPOVIO in combination with bortezomib and dexamethasone included:

  • Neurologic disorders: mental status changes (9%) and syncope (3.6%)

Table 6 summarizes selected laboratory abnormalities in BOSTON.

Table 6: Select Laboratory Abnormalities (≥15%) That Worsened from Baseline in Patients with Multiple Myeloma Who Received XPOVIO in Combination with Bortezomib and Dexamethasone (SVd) in BOSTON

Laboratory AbnormalityWeekly SVdTwice Weekly Vd
All Grades
(%)
Grade 3 or 4
(%)
All Grades
(%)
Grade 3 or 4
(%)
Hematologic
  Platelet count decrease92435119
  Lymphocyte count decrease77387027
  Hemoglobin decrease711751a12
  Neutrophil count decrease4812197
Chemistry
  Glucose increase623.8474.1
  Phosphate decrease61234211
  Sodium decrease5814253
  Calcium decrease552.1471
  Blood urea nitrogen increase415405
  Creatinine increase283.6241.5
  Potassium decrease276223.5
  Magnesium decrease27<1231.5
  Potassium increase184.1212.5
Hepatic
  ALT increase333.130<1
  Albumin decrease27<135<1
  AST increase241.519<1
  Bilirubin increase161132
  ALP increase12016<1
The denominator used to calculate the rate varied from 91 to 201 based on the number of patients with at least one post-treatment value.
a. Includes one fatal anemia.

XPOVIO in Combination with Dexamethasone (Sd)

The safety of XPOVIO in combination with dexamethasone was evaluated in STORM [see Clinical Studies]. Patients received XPOVIO 80 mg orally with dexamethasone 20 mg on Days 1 and 3 of every week (n=202). The median duration of XPOVIO treatment was 8 weeks (range: 1 to 60 weeks). The median dose was 115 mg (range: 36 to 200 mg) per week.

Fatal adverse reactions occurred in 9% of XPOVIO treated patients. Serious adverse reactions occurred in 58% of patients.

The treatment discontinuation rate due to adverse reactions was 27%; 53% of patients had a reduction in the XPOVIO dose, and 65% had the dose of XPOVIO interrupted. Thrombocytopenia was the leading cause of dose modification, resulting in dose reduction and/or interruption in >25% of patients. The most frequent adverse reactions requiring permanent discontinuation in 4% or greater of patients who received XPOVIO included fatigue, nausea, and thrombocytopenia.

Table 7 summarizes the adverse reactions in STORM.

Table 7: Adverse Reactions (≥10%) in Patients Who Received XPOVIO in STORM

Adverse ReactionXPOVIO 80 mg twice weekly + Dexamethasone
(n=202)
All Grades
(%)
Grades ≥3
(%)
Thrombocytopeniaa7461
Fatigueb7322
Nausea729
Anemiac5940
Decreased appetite534.5
Weight decreased470.5
Diarrhea446
Vomiting413.5
Hyponatremia3922
Neutropeniad3421
Leukopenia2811
Constipation251.5
Dyspneae243.5k
Upper respiratory tract infectionf213
Coughg160
Mental status changesh167
Pyrexia160.5
Hyperglycemia157
Dizziness150
Insomnia152
Lymphopenia1510
Dehydration143.5
Hypercreatininemiai142
Pneumoniaj139k
Epistaxis120.5
Hypokalemia123.5
Dysgeusia110
Vision blurred100.5
Headache100
a. Thrombocytopenia includes thrombocytopenia and platelet count decreased.
b. Fatigue includes fatigue and asthenia.
c. Anemia includes anemia and hematocrit decreased.
d. Neutropenia includes neutropenia and neutrophil count decreased.
e. Dyspnea includes dyspnea, dyspnea exertional, and dyspnea at rest.
f. Upper respiratory tract infection includes upper respiratory tract infection, respiratory tract infection, pharyngitis,
nasopharyngitis, bronchitis, bronchiolitis, respiratory syncytial virus infection, parainfluenza virus infection, rhinitis, rhinovirus infection, and adenovirus infection.
g. Cough includes cough, productive cough, and upper-airway cough syndrome.
h. Mental status changes includes mental status changes, confusional state, and delirium.
i. Hypercreatininemia includes hypercreatininemia and hypercreatinemia.
j. Pneumonia includes pneumonia, atypical pneumonia, lung infection, lower respiratory tract infection, pneumocystis jirovecii pneumonia, pneumonia aspiration, pneumonia influenzal, and pneumonia viral.
k. Includes fatal event.

Diffuse Large B-Cell Lymphoma

The safety of XPOVIO was evaluated in SADAL [see Clinical Studies]. Patients received XPOVIO 60 mg orally on Days 1 and 3 of every week (n=134). The study required an absolute neutrophil count ≥1000/μL, platelet count ≥75,000/μL, hepatic transaminases ≤2.5 times upper limit of normal (ULN) unless abnormal from lymphoma, and bilirubin ≤2 times ULN. The study permitted a maximum of 5 prior systemic regimens for DLBCL. Antiemetic prophylaxis with a 5HT-3 receptor antagonist was required. The median duration of XPOVIO treatment was 2.1 months (range: 1 week to 3.7 years) with 38% receiving at least 3 months and 22% receiving at least 6 months of treatment. The median exposure was 100 mg per week.

Fatal adverse reactions occurred in 3.7% of patients within 30 days and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reaction was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients who received XPOVIO; the most frequent serious adverse reaction was infection (21% of patients).

Discontinuation due to adverse reactions occurred in 17% of patients who received XPOVIO. Adverse reactions which results in discontinuation in ≥2% of patients included: infection, fatigue, thrombocytopenia, and nausea.

Adverse reactions led to XPOVIO dose interruption in 61% of patients and dose reduction in 49%, with 17% of all patients having 2 or more dose reductions. The median time to first dose modification (reduction or interruption) was 4 weeks, with the leading causes being thrombocytopenia (40% of all patients), neutropenia (16%), fatigue (16%), nausea (10%), and anemia (10%). The median time to first dose reduction was 6 weeks, with 83% of first dose reductions occurring within the first 3 months.

The most common adverse reactions, excluding laboratory abnormalities, in ≥20% of patients were fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Table 8 summarizes selected adverse reactions in SADAL.

Table 8: Adverse Reactions (≥10%), Excluding Laboratory Terms, in Patients with DLBCL Who Received XPOVIO in SADAL

Adverse ReactionXPOVIO 60 mg twice weekly
(n=134)
All Grades
(%)
Grade 3 or 4
(%)
General Conditions
  Fatiguea6315
  Pyrexia224.5
  Edemab172.2
Gastrointestinal
  Nausea576
  Diarrheac373.0
  Constipation290
  Vomiting281.5
  Abdominal paind100
Metabolism and Nutrition
  Appetite decreasee373.7
  Weight decrease300
  Respiratory
  Coughf180
  Dyspneag101.5
Infections
  Upper respiratory tract infectionh171.5
  Pneumonia106
  Urinary tract infectioni103
Nervous System
  Dizzinessj160.7
  Taste disorderk130
  Mental status changesl113.7
  Peripheral neuropathy, sensorym100
Musculoskeletal
  Musculoskeletal painn152.2
Vascular
  Hypotension133.0
  Hemorrhageo100.7
Eye Disorders
  Vision blurredp110.7
a. Fatigue includes fatigue and asthenia.
b. Edema includes edema, swelling, swelling face, edema peripheral, peripheral swelling, acute pulmonary edema.
c. Diarrhea includes diarrhea, post-procedural diarrhea, gastroenteritis.
d. Abdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, epigastric discomfort.
e. Appetite decrease includes decreased appetite and hypophagia.
f. Cough includes cough and productive cough.
g. Dyspnea includes dyspnea and dyspnea exertional.
h. Upper respiratory tract infection includes upper respiratory tract infection, sinusitis, nasopharyngitis, pharyngitis, rhinitis, viral upper respiratory infection.
i. Urinary tract infection includes urinary tract infection and specific types of urinary tract infection.
j. Dizziness includes dizziness and vertigo.
k. Taste disorder includes taste disorder, dysgeusia, ageusia.
l. Mental status changes include confusional state, amnesia, cognitive disorder, hallucination, delirium, somnolence, depressed level of consciousness, memory impairment.
m. Peripheral neuropathy includes peripheral neuropathy, peripheral sensory neuropathy, sensory disturbance, paresthesia, neuralgia.
n. Musculoskeletal pain includes musculoskeletal pain, back pain, musculoskeletal chest pain, neck pain, pain in extremity, bone pain.
o. Hemorrhage includes hemorrhage, hematoma, hematuria, epistaxis, rectal hemorrhage, injection site hematoma, subdural hematoma, upper gastrointestinal hemorrhage, corneal bleeding.
p. Vision blurred includes vision blurred, visual acuity reduced, visual impairment.

Clinically relevant adverse reactions 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%)

Table 9 summarizes selected new or worsening laboratory abnormalities in SADAL. Grade 3-4 laboratory abnormalities in ≥15% included thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. Grade 4 laboratory abnormalities in ≥5% were thrombocytopenia (18%), lymphopenia (5%), and neutropenia (9%).

Table 9: Select Laboratory Abnormalities (≥15%) Worsening from Baseline in Patients with DLBCL Who Received XPOVIO in SADAL

Laboratory AbnormalityXPOVIO 60 mg twice weekly
All Grades
(%)
Grade 3 or 4
(%)
Hematologic
  Platelet count decrease8649
  Hemoglobin decrease8225
  Lymphocyte count decrease6337
  Neutrophil count decrease5831
Chemistry
  Sodium decrease6216
  Glucose increase57a5
  Creatinine increase473.9
  Phosphate decrease3411
  Magnesium decrease302.6
  Calcium decrease300.9
  Potassium increase263.9
  Potassium decrease237
  CK increaseb211.9
Hepatic
  ALT increase290.8
  Albumin decrease250
  AST increase243.1
  Bilirubin increase161.6
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.
a. Not fasting.
b. CK increase was not associated with reports of myopathy or myalgia.

Read the entire FDA prescribing information for Xpovio (Selinexor Tablets)

© Xpovio Patient Information is supplied by Cerner Multum, Inc. and Xpovio Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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