Ventoxen 100 mg (Venetoclax )

Description

COMPOSITION
VENTOXEN 10 tablet: Each film coated tablet contains Venetoclax
INN 10 mg.
VENTOXEN tablet: Each film coated tablet contains Venetoclax INN
100 mg.
PHARMACOLOGY
Venetoclax is a selective and orally bioavailable small-molecule
inhibitor of BCL-2, an antiapoptotic protein. Overexpression of BCL-2
has been demonstrated in CLL and AML cells where it mediates
tumor cell survival and has been associated with resistance to
chemotherapeutics. Venetoclax helps restore the process of
apoptosis by binding directly to the BCL-2 protein, displacing
pro-apoptotic proteins like BIM, triggering mitochondrial outer
membrane permeabilization and the activation of caspases. In
nonclinical studies, Venetoclax has demonstrated cytotoxic activity in
tumor cells that overexpress BCL-2.
Pharmacokinetic
Venetoclax mean steady state Cmax was 2.1 ± 1.1 mcg/mL and
AUC0-24h was 32.8 ± 16.9 mcg•h/mL following administration of 400
mg once daily with a low-fat meal. Venetoclax steady state AUC
increased proportionally over the dose range of 150 to 800 mg. The
pharmacokinetics of venetoclax does not change over time.
Absorption Maximum plasma concentration of Vennetoclax was
reached 5 to 8 hours following multiple oral administration under fed
conditions. The terminal elimination half-life of Venetoclax was
approximately 26 hours