Scemblix Description

20 mg asciminib film-coated tablets: Pale yellow, unscored, round, biconvex, with beveled edges, film-coated tablet debossed with "20"on one side and the "Novartis" logo on the other side.
Each film-coated tablet contains 20 mg of asciminib (equivalent to 21.62 mg of asciminib HCl).
40 mg asciminib film-coated tablets: Violet white, unscored, round, biconvex, with beveled edges, film-coated tablet debossed with "40" on one side and the "Novartis" logo on the other side.
Each film-coated tablet contains 40 mg of asciminib (equivalent to 43.24 mg of asciminib HCl).
SCEMBLIX (asciminib) is a kinase inhibitor. The chemical name of the drug substance is N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-3-yl)pyridine-3-carboxamide-hydrogen chloride (1/1). Asciminib hydrochloride is a white to slightly yellow powder. The molecular formula of asciminib hydrochloride is C₂₀H₁₈ClF₂N₅O₃·HCl, and the relative molecular mass is 486.30 g/mol for the hydrochloride salt and 449.84 g/mol for the free base.
Excipients/Inactive Ingredients: The tablets contain colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hydroxypropyl cellulose, lactose monohydrate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum. The 20 mg tablets contain ferric oxide, yellow and ferric oxide, red. The 40 mg tablets contain ferrosoferric oxide and ferric oxide, red.