ASH Clinical News ACN_4.4_SUPP_Digital Version | Page 11

on results of the population pharmacokinetic analysis, a trend for increased
adverse events was observed in patients with moderate hepatic impairment;
monitor these patients more closely for signs of toxicity during the initiation
and dose ramp-up phase. A recommended dose has not been determined
for patients with severe hepatic impairment.
OVERDOSAGE
There is no specific antidote for VENCLEXTA. For patients who experience
overdose, closely monitor and provide appropriate supportive treatment;
during ramp-up phase interrupt VENCLEXTA and monitor carefully for signs
and symptoms of TLS along with other toxicities. Based on venetoclax large
volume of distribution and extensive protein binding, dialysis is unlikely to
result in significant removal of venetoclax.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with venetoclax.
Venet