XPOVIO Film-coated tablet Ref.[10395] Active ingredients: Selinexor

Source: FDA, National Drug Code (US) Revision Year: 2020

Product description

Selinexor is a nuclear export inhibitor. Selinexor is (2Z)3{3-[3,5-bis(trifluoromethyl)phenyl]-1H-1,2,4-triazol-1-yl}N'(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C₁₇H₁₁F₆N₇O and a molecular mass of 443.31 g/mol. The molecular structure is shown below:

Each XPOVIO (selinexor) tablet contains 20 mg of selinexor as the active ingredient. XPOVIO tablets are blue, round, bi-convex, film-coated tablets with “K20” debossed on one side and nothing on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.

Dosage Forms and Strengths
Tablets: 20 mg, blue, round, bi-convex, film-coated tablets with “K20” debossed on one side and nothing on the other side.

How Supplied

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 seven 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
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

Manufactured for and marketed by: Karyopharm Therapeutics Inc., 85 Wells Avenue, Newton, MA, 02459.

Drugs

Drug	Countries
XPOVIO	Israel, United States

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