asciminib 40 mg
1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). ( 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 9: 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 (equivalent to 21.62 mg of
ASCIMINIB HCl). 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 (equivalent to 43.24 mg of
ASCIMINIB HCl). 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 (equivalent to 108.10 mg of
ASCIMINIB HCl). 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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