32 Selinexor 20 MG Oral Tablet Xpovio Pack Xpovio 80 MG Twice Weekly 160 MG total weekly dose Carton
1 INDICATIONS AND USAGE XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1.1 ). In combination with dexamethasone 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 ( 1.1 ). 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s) ( 1.2 ). 1.1 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. 1.2 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 ( 14.2 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Karyopharm Therapeutics Inc.
ROUND BLUE K20
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16 HOW SUPPLIED/STORAGE AND HANDLING XPOVIO 20 mg tablets are blue, round, bi-convex, film-coated debossed with “K20” on one side and nothing on the other side. XPOVIO 40 mg tablets are blue, oval, film-coated, debossed on both sides with “X40”. XPOVIO 50 mg tablets are blue, oval, film-coated, debossed on both sides with “X50”. XPOVIO 60 mg tablets are blue, oval, film-coated, debossed on both sides with “X60”. Tablets are packaged in a child-resistant blister pack. Four blister packs are supplied per carton. The following twelve dose presentations are available: Weekly dose Strength per tablet Carton (28 day supply) 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 60 mg twice weekly 20 mg 4 blister packs (24 tablets total in the carton) Each blister has six 20 mg tablets Outer carton NDC 72237-101-03 Blister pack NDC 72237-101-13 100 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 40 mg twice weekly 20 mg 4 blister packs (16 tablets total in the carton) Each blister has four 20 mg tablets Outer carton NDC 72237-101-06 Blister pack NDC 72237-101-16 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 40 mg once weekly 20 mg 4 blister packs (8 tablets total in the carton) Each blister has two 20 mg tablets Outer carton NDC 72237-101-07 Blister pack NDC 72237-101-17 100 mg once weekly 50 mg 4 blister packs (8 tablets total in the carton) Each blister has two 50 mg tablets Outer carton NDC 72237-103-05 Blister pack NDC 72237-103-15 80 mg once weekly 40 mg 4 blister packs (8 tablets total in the carton) Each blister has two 40 mg tablets Outer carton NDC 72237-102-02 Blister pack NDC 72237-102-12 40 mg twice weekly 40 mg 4 blister packs (8 tablets total in the carton) Each blister has two 40 mg tablets Outer carton NDC 72237-102-06 Blister pack NDC 72237-102-16 60 mg once weekly 60 mg 4 blister packs (4 tablets total in the carton) Each blister has one 60 mg tablet Outer carton NDC 72237-104-01 Blister pack NDC 72237-104-11 40 mg once weekly 40 mg 4 blister packs (4 tablets total in the carton) Each blister has one 40 mg tablet Outer carton NDC 72237-102-07 Blister pack NDC 72237-102-17 Store at or below 30°C (86°F).
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