Source: FDA, National Drug Code (US) Revision Year: 2020
Venetoclax is a BCL-2 inhibitor. It is a light yellow to dark yellow solid with the empirical formula C45H50ClN7O7S and a molecular weight of 868.44. Venetoclax is described chemically as 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)N({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)2(1Hpyrrolo[2,3b]pyridin-5-yloxy)benzamide) and has the following chemical structure:
Venetoclax has very low aqueous solubility.
VENCLEXTA tablets for oral use are supplied as pale yellow or beige tablets that contain 10, 50, or 100 mg venetoclax as the active ingredient. Each tablet also contains the following inactive ingredients: copovidone, colloidal silicon dioxide, polysorbate 80, sodium stearyl fumarate, and calcium phosphate dibasic. In addition, the 10 mg and 100 mg coated tablets include the following: iron oxide yellow, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg coated tablets also include the following: iron oxide yellow, iron oxide red, iron oxide black, polyvinyl alcohol, talc, polyethylene glycol and titanium dioxide. Each tablet is debossed with “V” on one side and “10”, “50” or “100” corresponding to the tablet strength on the other side.
Dosage Forms and Strengths | ||||||||
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Table 8. VENCLEXTA Tablet Strength and Description:
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How Supplied | |||||||||||||||||||||||||||
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VENCLEXTA is dispensed as follows:
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. Manufactured and Marketed by: AbbVie Inc., North Chicago, IL 60064 and Marketed by: Genentech USA, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990 |
Drug | Countries | |
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VENCLEXTA | Australia, Brazil, Canada, Ecuador, Hong Kong, Israel, Japan, New Zealand, Singapore, United States |
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