venetoclax 10 MG Oral Tablet Venclexta
1 INDICATIONS AND USAGE VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.1 ) In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 1.2 Acute Myeloid Leukemia VENCLEXTA is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
AbbVie Inc.
ROUND YELLOW V 10
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16 HOW SUPPLIED/STORAGE AND HANDLING VENCLEXTA is dispensed as follows: Packaging Presentation Number of Tablets National Drug Code (NDC) CLL/SLL Starting Pack Each pack contains four weekly wallet blister packs: Week 1 (14 x 10 mg tablets) Week 2 (7 x 50 mg tablets) Week 3 (7 x 100 mg tablets) Week 4 (14 x 100 mg tablets) 0074-0579-28 Wallet containing 10 mg tablets 14 x 10 mg tablets 0074-0561-14 Wallet containing 50 mg tablets 7 x 50 mg tablets 0074-0566-07 Unit dose blister containing 10 mg tablets 2 x 10 mg tablets 0074-0561-11 Unit dose blister containing 50 mg tablet 1 x 50 mg tablet 0074-0566-11 Unit dose blister containing 100 mg tablet 1 x 100 mg tablet 0074-0576-11 Bottle containing 100 mg tablets 28 x 100 mg tablets 0074-0576-30 Bottle containing 100 mg tablets 120 x 100 mg tablets 0074-0576-22 Bottle containing 100 mg tablets 180 x 100 mg tablets 0074-0576-34 VENCLEXTA 10 mg film-coated tablets are round, biconvex shaped, pale yellow debossed with “V” on one side and “10” on the other side. VENCLEXTA 50 mg film-coated tablets are oblong, biconvex shaped, beige debossed with “V” on one side and “50” on the other side. VENCLEXTA 100 mg film-coated tablets are oblong, biconvex shaped, pale yellow debossed with “V” on one side and “100” on the other side. Store in original container at or below 86°F (30°C). Dispense to patient in original container to protect from moisture.
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