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Xpovio Generic Name & Formulations
Legal Class
Rx
General Description
Selinexor 20mg, 40mg, 50mg, 60mg; tabs.
Pharmacological Class
Nuclear export inhibitor.
How Supplied
Tabs 20mg—8, 12, 16, 20, 24, 32; 40mg—4, 8; 50mg—8; 60mg—4
Manufacturer
Generic Availability
NO
Xpovio Indications
Indications
In combination with bortezomib and dexamethasone for the treatment of multiple myeloma (MM) in adults who have received at least 1 prior therapy. In combination with dexamethasone for the treatment of relapsed or refractory MM in adults 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. 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.
Xpovio Dosage and Administration
Adult
Premedicate with 5-HT3 antagonists and/or other anti-nausea agents prior to and during treatment. Swallow whole. Continue until disease progression or unacceptable toxicity. MM (in combination with bortezomib and dexamethasone): 100mg once weekly on Day 1 of each week; give with bortezomib once weekly on Day 1 of each week for 4 weeks followed by 1 week off, and oral dexamethasone twice weekly on Days 1 and 2 of each week. MM (in combination with dexamethasone): 80mg on Days 1 and 3 of each week; give with oral dexamethasone with each Xpovio dose on scheduled days. DLBCL: 60mg on Days 1 and 3 of each week. Dose modification for adverse reactions: see full labeling.
Children
Not established.
Xpovio Contraindications
Not Applicable
Xpovio Boxed Warnings
Not Applicable
Xpovio Warnings/Precautions
Warnings/Precautions
Monitor CBC with differential (eg, platelets, WBC), blood chemistries (eg, sodium), body weight, nutritional and volume status at baseline, during treatment (more frequently for first 3 months), and as clinically indicated. Monitor for signs/symptoms of bleeding, infection; evaluate and treat promptly. Consider supportive measures for signs of infection (eg, antimicrobials, G-CSFs). Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction. Correct sodium levels for concurrent hyperglycemia and high serum paraprotein levels. Maintain adequate hydration, caloric intake, hemoglobin level. New onset or exacerbation of cataracts. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Nursing mothers: not recommended (during and for 1 week after the last dose).
Xpovio Pharmacokinetics
See Literature
Xpovio Interactions
Interactions
Increased risk of neurological toxicity with concomitant other products that cause dizziness or mental status changes.
Xpovio Adverse Reactions
Adverse Reactions
Thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, upper respiratory tract infection, pyrexia, lymphopenia, peripheral neuropathy, cataract, hypophosphatemia; infections (eg, pneumonia, sepsis), neurological toxicity.
Xpovio Clinical Trials
See Literature
Xpovio Note
Not Applicable
Xpovio Patient Counseling
See Literature
