XPOVIO (selinexor) 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. Four blister packs are supplied per carton. The following four dose presentations are available:
Weekly dose Strength per tablet Carton Blister Pack NDC
80 mg twice weekly 20 mg 4 blister packs (32 tablets total in the carton) Each blister has eight 20 mg tablets Outer carton NDC 72237-101-04
Blister pack NDC 72237-101-14
100 mg once weekly 20 mg 4 blister packs (20 tablets total in the carton) Each blister has five 20 mg tablets Outer carton NDC 72237-101-05
Blister pack NDC 72237-101-15
80 mg once weekly 20 mg 4 blister packs (16 tablets total in the carton) Each blister has four 20 mg tablets Outer carton NDC 72237-101-02
Blister pack NDC 72237-101-12
60 mg once weekly 20 mg 4 blister packs (12 tablets total in the carton) Each blister has three 20 mg tablets Outer carton NDC 72237-101-01
Blister pack NDC 72237-101-11
16.2 Storage
Store at or below 30�C (86�F). These highlights do not include all the information needed to use XPOVIO safely and effectively. See full prescribing information for XPOVIO.
XPOVIO� (selinexor) tablets, for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
XPOVIO 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.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial (1).
DOSAGE AND ADMINISTRATION
Recommended starting dosage of XPOVIO is 80 mg in combination with dexamethasone taken orally on Days 1 and 3 of each week (2.1).
Manage adverse reactions using dosage modifications and supportive care (2.4, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6).
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Thrombocytopenia: Monitor platelet counts at baseline, during treatment, and as clinically indicated. Manage with dose interruption, reduction, and supportive care (2.4, 5.1).
Neutropenia: Monitor neutrophil counts at baseline, during treatment, and as clinically indicated. Manage with dose interruption and/or reduction and granulocyte colony-stimulating factors (G-CSFs) (2.4, 5.2).
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care (2.4, 5.3).
Hyponatremia: Monitor serum sodium levels at baseline, during treatment, and as clinically indicated. Correct for concurrent hyperglycemia and high serum paraprotein levels (2.4, 5.4).
Infections: Monitor for signs/symptoms of infection and treat promptly (5.2, 5.5).
Neurological Toxicity: Avoid taking XPOVIO with other medications that may cause dizziness or confusion. Avoid situations where dizziness or confusional state may be a problem. Optimize hydration status, blood counts and concomitant medications to avoid dizziness or confusion (5.6).
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential, and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception (5.7, 8.1, 8.3).
ADVERSE REACTIONS
The most common adverse reactions (incidence ?20%) are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed (8.2).
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2019