Xpovio
(selinexor)Dosage & Administration
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Xpovio Prescribing Information
Multiple Myeloma
- XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
- XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma 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.
Diffuse Large B-Cell Lymphoma
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.
This indication is approved under accelerated approval based on response rate [see Clinical Studies ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Recommended Dosage for Multiple Myeloma
In Combination with Bortezomib and Dexamethasone (XVd)
The recommended dosage of XPOVIO is 100 mg taken orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with:
- Bortezomib 1.3 mg/m2 administered subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off.
- Dexamethasone 20 mg taken orally twice weekly on Days 1 and 2 of each week.
Refer to Clinical Studies and the prescribing information of bortezomib and dexamethasone for additional dosing information.
In Combination with Dexamethasone (Xd)
The recommended dosage of XPOVIO is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20 mg taken orally with each dose of XPOVIO on Days 1 and 3 of each week.
For additional information regarding the administration of dexamethasone, refer to its prescribing information.
Recommended Dosage for Diffuse Large B-Cell Lymphoma
The recommended dosage of XPOVIO is 60 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity.
Recommended Monitoring for Safety
Monitor complete blood count (CBC) with differential, standard blood chemistries, body weight, nutritional status, and volume status at baseline and during treatment as clinically indicated. Monitor more frequently during the first three months of treatment [see Warning and Precautions ]. Assess the need for dosage modifications of XPOVIO for adverse reactions [see Dosage and Administration ].
Recommended Concomitant Treatments
Advise patients to maintain adequate fluid and caloric intake throughout treatment. Consider intravenous hydration for patients at risk of dehydration [see Warnings and Precautions ].
Provide prophylactic antiemetics. Administer a 5-HT3 receptor antagonist and other anti-nausea agents prior to and during treatment with XPOVIO [see Warnings and Precautions ].
Dosage Modification for Adverse Reactions
Recommended XPOVIO dosage reduction steps are presented in Table 1.
| Recommended Starting Dosage | Multiple Myeloma In Combination with Bortezomib and Dexamethasone (XVd) | Multiple Myeloma In Combination with Dexamethasone (Xd) | Diffuse Large B-Cell Lymphoma |
| 100 mg once weekly | 80 mg Days 1 and 3 of each week (160 mg total per week) | 60 mg Days 1 and 3 of each week (120 mg total per week) | |
| First Reduction | 80 mg once weekly | 100 mg once weekly | 40 mg Days 1 and 3 of each week (80 mg total per week) |
| Second Reduction | 60 mg once weekly | 80 mg once weekly | 60 mg once weekly |
| Third Reduction | 40 mg once weekly | 60 mg once weekly | 40 mg once weekly |
| Fourth Reduction | Permanently discontinue | Permanently discontinue | Permanently discontinue |
Recommended dosage modifications for hematologic adverse reactions in patients with multiple myeloma and DLBCL are presented in Table 2 and Table 3, respectively. Recommended dosage modifications for nonhematologic adverse reactions are presented in Table 4.
| Adverse Reaction | Occurrence | Action |
| Thrombocytopenia[see Warning and Precautions ] | ||
| Platelet count 25,000 to less than 75,000/mcL | Any |
|
| Platelet count 25,000 to less than 75,000/mcL with concurrent bleeding | Any |
|
| Platelet count less than 25,000/mcL | Any |
|
| Adverse Reaction | Occurrence | Action |
| Neutropenia[see Warning and Precautions ] | ||
| Absolute neutrophil count of 0.5 to 1 x 109/L without fever | Any |
|
| Absolute neutrophil count less than 0.5 x 109/L OR febrile neutropenia | Any |
|
| Anemia | ||
| Hemoglobin less than 8 g/dL | Any |
|
| Life-threatening consequences | Any |
|
| Adverse Reaction | Occurrence | Action |
| Thrombocytopenia[see Warning and Precautions ] | ||
| Platelet count 50,000 to less than 75,000/mcL | Any |
|
| Platelet count 25,000 to less than 50,000/mcL without bleeding | 1st |
|
| Platelet count 25,000 to less than 50,000/mcL with concurrent bleeding | Any |
|
| Platelet count less than 25,000/mcL | Any |
|
| Neutropenia[see Warning and Precautions ] | ||
| Absolute neutrophil count of 0.5 to less than 1 x 109/L without fever | 1st occurrence |
|
| Recurrence |
| |
| Absolute neutrophil count less than 0.5 x 109/L OR Febrile neutropenia | Any |
|
| Anemia | ||
| Hemoglobin less than 8 g/dL | Any |
|
| Life-threatening consequences | Any |
|
| Adverse Reaction | Occurrence | Action |
| Nausea and Vomiting[see Warning and Precautions ] | ||
| 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 |
|
| Grade 3 nausea (inadequate oral caloric or fluid intake) OR Grade 3 or higher vomiting (6 or more episodes per day) | Any |
|
| Diarrhea[see Warning and Precautions ] | ||
| Grade 2 (increase of 4 to 6 stools per day over baseline) | 1st |
|
| 2nd and subsequent |
| |
| Grade 3 or higher (increase of 7 stools or more per day over baseline; hospitalization indicated) | Any |
|
| Weight Loss and Anorexia[see Warning and Precautions ] | ||
| Weight loss of 10% to less than 20% OR Anorexia associated with significant weight loss or malnutrition | Any |
|
| Hyponatremia[see Warning and Precautions ] | ||
| Sodium level 130 mmol/L or less | Any |
|
| Fatigue | ||
| Grade 2 lasting greater than 7 days OR Grade 3 | Any |
|
| Ocular Toxicity[see Warning and Precautions ] | ||
| Grade 2, excluding cataract | Any |
|
| Grade ≥3, excluding cataract | Any |
|
| Other Non-Hematologic Adverse Reactions[see Warning and Precautions ] | ||
| Grade 3 or 4 | Any |
|
Administration
Each XPOVIO dose should be taken at approximately the same time of day and each tablet should be swallowed whole with water. Do not break, chew, crush, or divide the tablets.
If a dose of XPOVIO is missed or delayed, instruct patients to take their next dose at the next regularly scheduled time.
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.
Tablets:
10 mg, blue, round, bi-convex, film-coated tablets with “X10” debossed on one side and nothing on the other side.
20 mg, blue, round, bi-convex, film-coated tablets with “K20” debossed on one side and nothing on the other side.
40 mg tablets, blue, oval, film-coated, debossed on both sides with “X40”.
50 mg tablets, blue, oval, film-coated, debossed on both sides with “X50”.
60 mg tablets, blue, oval, film-coated, debossed on both sides with “X60”.
Pregnancy
Risk Summary
Based on findings in animal studies and its mechanism of action [see Clinical Pharmacology ], XPOVIO can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of selinexor to pregnant rats during organogenesis resulted in structural abnormalities and alterations to growth at exposures that were below those occurring clinically at the recommended dose (see Data). Advise pregnant women of the risks to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal data
In an embryo-fetal development study in pregnant rats, daily oral administration of selinexor at 0, 0.25, 0.75, or 2 mg/kg throughout organogenesis caused incomplete or delayed ossification, skeletal variations, and reduced fetal weight compared with controls at a dose of 0.75 mg/kg (approximately 0.08-fold of human area under the curve [AUC] at the recommended dose). Malformations were observed at 2 mg/kg, including microphthalmia, fetal edema, malpositioned kidney, and persistent truncus arteriosus.
Lactation
Risk Summary
There is no information regarding the presence of selinexor or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with XPOVIO and for 1 week after the last dose.
Females and Males of Reproductive Potential
XPOVIO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ].
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating XPOVIO [see Use in Specific Populations ].
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.
Males
Advise males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.
Infertility
Females and Males
Based on findings in animals, XPOVIO may impair fertility in females and males of reproductive potential [see Nonclinical Toxicology ].
Pediatric Use
The safety and effectiveness of XPOVIO have not been established in pediatric patients.
Geriatric Use
In BOSTON, of the 195 patients with multiple myeloma who received XPOVIO in combination with bortezomib and dexamethasone, 56% were 65 years of age and older, while 17% were 75 years of age and older. No overall differences in effectiveness were observed between these patients and younger patients. When comparing patients 65 years of age and older to younger patients, older patients had a higher incidence of discontinuation due to an adverse reaction (28% vs 13%) and a higher incidence of serious adverse reactions (56% vs 47%).
In STORM, of the 202 patients with multiple myeloma who received XPOVIO, 49% were 65 years of age and older, while 11% were 75 years of age and older. No overall difference in effectiveness was observed in patients over 65 years of age, including patients over 75 years of age, when compared with younger patients. When comparing patients 75 years of age and older to younger patients, older patients had a higher incidence of discontinuation due to an adverse reaction (44% vs 27%), higher incidence of serious adverse reactions (70% vs 58%), and higher incidence of fatal adverse reactions (17% vs 9%).
Among 134 patients with DLBCL who received XPOVIO in SADAL, 61% were 65 years of age and older, while 25% were 75 years of age and older. Clinical studies of XPOVIO in patients with relapsed or refractory DLBCL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
None.
Thrombocytopenia
XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia is the leading cause of dosage modifications [see Adverse Reactions ].
In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), thrombocytopenia was reported in 92% of patients and severe (Grade 3-4) thrombocytopenia was reported in 43% of patients. The median time to first onset was 22 days for any grade thrombocytopenia and 43 days for Grade 3 or 4 thrombocytopenia. Bleeding occurred in 16% of patients with thrombocytopenia, clinically significant bleeding (Grade ≥3 bleeding) occurred in 4% of patients with thrombocytopenia, and fatal hemorrhage occurred in 2% of patients with thrombocytopenia. Permanent discontinuations of XPOVIO due to thrombocytopenia occurred in 2% of patients.
In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), thrombocytopenia was reported as an adverse reaction in 74% of patients and severe (Grade 3-4) thrombocytopenia was reported in 61% of patients. The median time to onset of the first event was 22 days. Bleeding occurred in 23% of patients with thrombocytopenia, clinically significant bleeding occurred in 5% of patients with thrombocytopenia, and fatal hemorrhage occurred in <1% of patients.
In patients with DLBCL who received XPOVIO 60 mg twice weekly (SADAL, n=134), thrombocytopenia developed or worsened in 86% of patients, including Grade 3-4 thrombocytopenia in 49% of patients (Grade 4, 18%). The median time to first onset was 28 days for any grade thrombocytopenia and 33 days for Grade 3 or 4 thrombocytopenia.
Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first three 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 [see Dosage and Administration ].
Neutropenia
XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection [see Adverse Reactions ].
In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), neutropenia was reported in 48% of patients and severe neutropenia (Grade 3-4) was reported in 12% of patients. The median time to onset of the first event was 23 days for any grade neutropenia and 40 days for Grade 3-4 neutropenia. Febrile neutropenia was reported in <1% of patients.
In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), neutropenia was reported as an adverse reaction in 34% of patients and severe (Grade 3-4) neutropenia was reported in 21% of patients. The median time to onset of the first event was 25 days. Febrile neutropenia was reported in 3% of patients.
In patients with DLBCL (SADAL, n=134), Grade 3 neutropenia developed in 21% of patients and Grade 4 neutropenia developed in 9% of patients. The median time to first onset of Grade 3 or 4 neutropenia was 32 days. Febrile neutropenia was reported in 3% of patients.
Obtain white blood cell counts with differential at baseline and throughout treatment. Monitor more frequently during the first three months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ].
Gastrointestinal Toxicity
XPOVIO can cause severe gastrointestinal toxicities [see Adverse Reactions ]. In patients with DLBCL (n=134), gastrointestinal toxicity occurred in 80% of patients with Grade 3 or 4 in 13%.
Nausea/Vomiting
In patients with multiple myeloma who received XPOVIO once weekly (BOSTON, n=195) with use of antiemetic prophylaxis (88% of patients), nausea was reported in 50% of patients and Grade 3 nausea was reported in 8% of patients. The median time to onset of the first event was 6 days. Vomiting was reported in 21% of patients and Grade 3 vomiting was reported in 4.1% of patients. The median time to onset of the first event was 8 days. Permanent discontinuation due to nausea occurred in 3.1% of patients and due to vomiting occurred in 2.1% of patients.
In patients with multiple myeloma receiving XPOVIO 80 mg twice weekly (STORM, n=202) with use of antiemetic prophylaxis, nausea was reported as an adverse reaction in 72% of patients and Grade 3 nausea occurred in 9%. The median time to first onset of nausea was 3 days. Vomiting was reported in 41% of patients and Grade 3 vomiting occurred in 4% of patients. The median time to first onset of vomiting was 5 days.
In patients with DLBCL (SADAL, n=134) with use of antiemetic prophylaxis, nausea occurred in 57% of patients and Grade 3 nausea occurred in 6% of patients. Vomiting occurred in 28% of patients and Grade 3 vomiting occurred in 1.5% of patients. The median time to first onset was 3 days for nausea and 7 days for vomiting.
Provide prophylactic antiemetics. Administer 5-HT3 receptor antagonists and other anti-nausea agents prior to and during treatment with XPOVIO. Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ]. Administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.
Diarrhea
In patients with multiple myeloma who received XPOVIO once weekly (BOSTON, n=195), diarrhea was reported in 32% of patients and Grade 3 diarrhea was reported in 6% of patients. The median time to onset of the first event was 50 days. Permanent discontinuation due to diarrhea occurred in 1% of patients.
In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), diarrhea was reported as an adverse reaction in 44% of patients and Grade 3 diarrhea occurred in 6% of patients. The median time to onset of diarrhea was 15 days.
In patients with DLBCL (SADAL, n=134), diarrhea occurred in 37% of patients and Grade 3 diarrhea occurred in 3% of patients treated with XPOVIO. The median time to onset of the first event was 12 days.
Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ]. Provide standard anti-diarrheal agents, administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.
Anorexia/Weight Loss
In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), anorexia was reported in 35% of patients and Grade 3 anorexia was reported in 3.6% of patients. The median time to onset of the first event was 35 days. Permanent discontinuations due to anorexia occurred in 2.1% of patients. Weight loss was reported in 26% of patients and Grade 3 weight loss was reported in 2.1% of patients. The median time to onset of the first event was 58 days. Permanent discontinuation due to weight loss occurred in 1% of patients.
In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM n=202), anorexia was reported as an adverse reaction in 53% of patients and Grade 3 anorexia occurred in 5% of patients. The median time to onset of anorexia was 8 days. Weight loss was reported as an adverse reaction in 47% of patients and Grade 3 weight loss occurred in 1% of patients treated with XPOVIO. The median time to onset of weight loss was 15 days.
In patients with DLBCL (SADAL, n=134), anorexia was reported as an adverse reaction in 37% of patients and Grade 3 anorexia occurred in 3.7% of patients treated with XPOVIO. Weight loss (Grade 1-2) was reported as an adverse reaction in 30% of patients.
Monitor weight, nutritional status, and volume status at baseline and throughout treatment. Monitor more frequently during the first three months of treatment. Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ]. Provide nutritional support, fluids, and electrolyte repletion as clinically indicated.
Hyponatremia
XPOVIO can cause severe or life-threatening hyponatremia [see Adverse Reactions ].
In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), hyponatremia was reported in 58% of patients and Grade 3-4 hyponatremia was reported in 14% of patients. The median time to first onset was 21 days for any grade hyponatremia and the median time to first onset for Grade 3 or 4 hyponatremia was 22 days.
In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), hyponatremia was reported as an adverse reaction in 39% of patients and Grade 3 or 4 hyponatremia was reported in 22% of patients. The median time to onset of the first event was 8 days.
In patients with DLBCL (SADAL, n=134), hyponatremia developed in 62% of patients and Grade 3 hyponatremia developed in 16% of patients treated with XPOVIO. In approximately 63% of cases, hyponatremia occurred in the context of gastrointestinal toxicity such as nausea, vomiting, diarrhea, dehydration, and anorexia.
Monitor sodium level at baseline and throughout treatment. Monitor more frequently during the first two months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Assess hydration status and manage hyponatremia per clinical guidelines, including intravenous saline and/or salt tablets as appropriate and dietary review. Interrupt, reduce dose or permanently discontinue based on severity of the adverse reaction [see Dosage and Administration ].
Serious Infection
XPOVIO can cause serious and fatal infections. Most of these infections were not associated with Grade 3 or higher neutropenia [see Adverse Reactions ].
In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), 69% of patients experienced any grade of infection. Grade ≥3 infections were reported in 32% of patients, and deaths from infections occurred in 3.1% of patients. The most frequently reported Grade ≥3 infection was pneumonia in 14% of patients, followed by sepsis in 4.1% and upper respiratory tract infection in 3.6% of patients.
In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), 52% of patients experienced any grade of infection. Grade ≥3 infections were reported in 25% of patients, and deaths from infections occurred in 4% of patients within 30 days of last treatment. Upper respiratory tract infection of any grade occurred in 21%, pneumonia in 13%, and sepsis in 6% of patients. The most frequently reported Grade ≥3 infections were pneumonia in 9% of patients, followed by sepsis in 6%. The median time to onset was 54 days for pneumonia and 42 days for sepsis.
In patients with DLBCL (SADAL, n=134), 25% of patients experienced Grade 3 or higher infection and 21% had an infection-related serious adverse reaction; 49% developed an infection of any grade, most frequently involving the upper or lower respiratory tract. The most frequently reported Grade ≥3 infections were lower respiratory tract infections in 9% of patients (including pneumonia in 6%), followed by sepsis (6%). The median time to onset of Grade ≥3 infection was 42 days.
Atypical infections reported after XPOVIO include, but are not limited to, fungal pneumonia and herpes virus infection.
Monitor for signs and symptoms of infection, evaluate and treat promptly.
Neurological Toxicity
XPOVIO can cause life-threatening neurological toxicities [see Adverse Reactions ].
In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), neurological adverse reactions (excluding peripheral neuropathy) including dizziness, syncope, depressed level of consciousness, vertigo, amnesia, and mental status changes (including delirium and confusional state) occurred in 26% of patients and severe events (Grade 3-4) occurred in 3.6% of patients. The median time to the first event was 29 days. Permanent discontinuation due to neurological adverse reactions occurred in 2.1% of patients.
In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), neurological adverse reactions, including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confusional state) occurred in 30% of patients and severe events (Grade 3-4) occurred in 9% of patients. The median time to the first event was 15 days.
In patients with DLBCL (SADAL, n=134), neurological adverse reactions occurred in 25% of patients and severe events (Grade 3-4) occurred in 6% of patients treated with XPOVIO. The most frequent manifestations were dizziness (16%) and mental status changes (11%), including confusion, cognitive disorders, somnolence, hallucination, delirium, and depressed level of consciousness. Syncope occurred in 2.2% of patients. The median time to the first event was 28 days. Among patients with such neurological adverse reactions, 68% recovered with a median time to recovery of 14 days.
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, such as operating heavy or potentially dangerous machinery, until the neurological toxicity fully resolves. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes. Institute fall precautions as appropriate.
Embryo-Fetal Toxicity
Based on data from animal studies and its mechanism of action, XPOVIO can cause fetal harm when administered to a pregnant woman. Selinexor administration to pregnant animals during organogenesis resulted in structural abnormalities and alterations to growth at exposures below those occurring clinically at the recommended dose.
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 [see Use in Specific Populations ].
Cataract
New onset or exacerbation of cataract has occurred during treatment with XPOVIO [see Adverse Reactions ]. In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), the incidence of new onset or worsening cataracts requiring clinical intervention was reported in 22% of patients. The median time to new onset of cataract was 228 days and was 237 days for worsening of cataract in patients presenting with cataract at start of XPOVIO therapy. Treatment of cataracts usually requires surgical removal of the cataract.