HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use XPOVIOsafely 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 withdexamethasone for the treatment of adult patients with relapsed orrefractory multiple myeloma (RRMM) who have received at least four priortherapies and whose disease is refractory to at least two proteasomeinhibitors, at least two immunomodulatory agents, and an anti‐CD38monoclonal antibody.
This indication is approved under accelerated approval based on responserate. 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 withdexamethasone 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, andsupportive care (2.4, 5.1).
•Neutropenia: Monitor neutrophil counts at baseline, during treatment, andas clinically indicated. Manage with dose interruption and/or reduction andgranulocyte colony‐stimulating factors (G‐CSFs) (2.4, 5.2).
•Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weightloss may occur. Provide antiemetic prophylaxis. Manage with doseinterruption 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 highserum 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 thatmay cause dizziness or confusion. Avoid situations where dizziness orconfusional state may be a problem. Optimize hydration status, bloodcounts and concomitant medications to avoid dizziness or confusion (5.6).
•Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductivepotential, and males with a female partner of reproductive potential, of thepotential 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, andupper respiratory tract infection (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm
Therapeutics Inc. at 1‐888‐209‐9326 or FDA at1‐800‐FDA‐1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed (8.2).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 07/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
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