asciminib 40 mg
1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). Previously treated Ph+ CML in CP. Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) Previously treated Ph+ CML in CP. ( 1 ) Ph+ CML in CP with the T315I mutation. ( 1 )
novartis pharmaceuticals corporation
ROUND WHITE Logo 40
Logo 40 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING SCEMBLIX tablets are available as: Table 12: SCEMBLIX Package Configurations and NDC Numbers Package configuration Tablet strength NDC number Bottle of 60 tablets 20 mg NDC 0078-1091-20 Bottle of 60 tablets 40 mg NDC 0078-1098-20 Bottle of 60 tablets 100 mg NDC 0078-1196-20 SCEMBLIX (
ASCIMINIB) 20 mg film-coated tablets are supplied as pale yellow, unscored, round, biconvex, with beveled edges, film-coated tablets containing 20 mg of
ASCIMINIB. Each tablet is debossed with “20” on one side and the “Novartis” logo on the other side. SCEMBLIX (
ASCIMINIB) 40 mg film-coated tablets are supplied as violet white, unscored, round, biconvex, with beveled edges, film-coated tablets containing 40 mg of
ASCIMINIB. Each tablet is debossed with “40” on one side and the “Novartis” logo on the other side. SCEMBLIX (
ASCIMINIB) 100 mg film-coated tablets are supplied as light red, unscored, round, biconvex, with beveled edges, film-coated tablets containing 100 mg of
ASCIMINIB. Each tablet is debossed with “100” on one side and the “Novartis” logo on the other side. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense and store in the original container in order to protect from moisture.
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