Medication Monitor



Generic Name (Trade Name—Company)
Notes
July 8, 2019

Selinexor

(Xpovio—Karyopharm Therapeutics)
FDA approves new treatment for refractory multiple myeloma

FDA granted accelerated approval to selinexor tablets in combination with the corticosteroid dexamethasone for treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Efficacy was evaluated in 83 patients with RRMM who were treated with selinexor in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3%. The median time to first response was 4 weeks, with a range of 1 to 10 weeks. The median duration of response was 3.8 months. The efficacy evaluation was supported by additional information from an ongoing, randomized trial in patients with multiple myeloma.

Common adverse effects of patients taking selinexor in combination with dexamethasone included leukopenia, neutropenia, thrombocytopenia, and anemia. Patients also reported vomiting, nausea, fatigue, diarrhea, fever, decreased appetite and weight, constipation, upper respiratory tract infections, and low blood sodium levels.

Health professionals are advised to monitor patients for low blood counts, platelets, and sodium levels. Patients should avoid taking selinexor with other medications that may cause dizziness or confusion and avoid situations where dizziness may be a problem. Health professionals also are advised to optimize the patient’s hydration status, blood counts, and other medications to avoid dizziness or confusion.

Females of reproductive age and males with a female partner of reproductive potential should use effective contraception during treatment. Women who are pregnant or breastfeeding should not take selinexor because it may cause harm to a developing fetus or newborn baby. Selinexor must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.