b'DO NOT RE-SIZEDO NOT RE-SIZE Ad unit Project # must match this project # 000-000000US-VENC-21030961Because of the potential for serious adverse reactions in a breastfed child,Acute Myeloid Leukemia Manufactured and Marketed by:advise women not to breastfeed during treatment with VENCLEXTA and forOf the 283 patients who received VENCLEXTA with azacitidine in VIALE-A,AbbVie Inc.1 week after the last dose.96% were 65 years of age and 60% were 75 years of age.North Chicago, IL 60064 Data Of the 13 patients who received VENCLEXTA in combination withand Animal Data decitabine in M14-358, 100% were 65 years of age and 62% were Marketed by:Venetoclax was administered (single dose; 150 mg/kg oral) to lactating75 years of age.Genentech USA, Inc.rats 8 to 10 days post-parturition. Venetoclax in milk was 1.6 times lowerOf the 142 patients who received VENCLEXTA in combination with A Member of the Roche Groupthan in plasma. Parent drug (venetoclax) represented the majority of thelow-dose cytarabine in VIALE-C, 92% were 65 years of age and 57%South San Francisco, CA 94080-4990 total drug-related material in milk, with trace levels of three metabolites.were 75 years of age. 2016-2021 AbbVie Inc.Females and Males of Reproductive Potential Clinical studies of VENCLEXTA in patients with AML did not include 2016-2021 Genentech, Inc.VENCLEXTA may cause fetal harm when administered to pregnant womensufficient numbers of younger adults to determine if patients 65 years ofRef:20068717-R1 Revised:October 2021[see Use in Specific Populations.age and older respond differently from younger adults. LAB-6043 MASTERPregnancy Testing Renal ImpairmentVerify pregnancy status in females of reproductive potential prior toDue to the increased risk of TLS, patients with reduced renal function initiating VENCLEXTA.(CLcr 80 mL/min, calculated by Cockcroft-Gault formula) require more Contraception intensive prophylaxis and monitoring to reduce the risk of TLS when Advise females of reproductive potential to use effective contraceptioninitiating treatment with VENCLEXTA [see Warnings and Precautions].US-VENC-210309during treatment with VENCLEXTA and for 30 days after the last dose.No dose adjustment is recommended for patients with mild, moderate or severe renal impairment (CLcr 15 mL/min). Infertility Hepatic ImpairmentBased on findings in animals, VENCLEXTA may impair male fertility.No dose adjustment is recommended for patients with mild (Child-Pugh A) Pediatric Use or moderate (Child-Pugh B) hepatic impairment. The safety and effectiveness of VENCLEXTA have not been established inReduce the dose of VENCLEXTA for patients with severe hepatic pediatric patients.impairment (Child-Pugh C); monitor these patients more frequently for Juvenile Animal Toxicity Data adverse reactions. In a juvenile toxicology study, mice were administered venetoclax at 10,OVERDOSAGE30, or 100 mg/kg/day by oral gavage from 7 to 60 days of age. ClinicalThere is no specific antidote for VENCLEXTA. For patients who experience signs of toxicity included decreased activity, dehydration, skin pallor, andoverdose, closely monitor and provide appropriate supportive treatment; hunched posture at 30 mg/kg/day. In addition, mortality and body weightduring ramp-up phase interrupt VENCLEXTA and monitor carefully for signs effects occurred at 100 mg/kg/day. Other venetoclax-related effects wereand symptoms of TLS along with other toxicities. Based on venetoclax reversible decreases in lymphocytes at 10 mg/kg/day; a dose of large volume of distribution and extensive protein binding, dialysis is 10 mg/kg/day is approximately 0.06 times the clinical dose of 400 mg on a mg/m2 basis for a 20 kg child.unlikely to result in significant removal of venetoclax. Geriatric UseChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaOf the 352 patients with previously treated CLL/SLL evaluated for safety from 3 open-label trials of VENCLEXTA monotherapy, 57% (201/352) were 65 years of age and 18% (62/352) were 75 years of age. No clinically meaningful differences in safety and effectiveness were observed between older and younger patients in the combination and monotherapy studies. 20068717-R1 Venclexta PB-7.5 x 10.5(3.5).indd 4 /08/Nov2021 8:41 AM16-5085 US-VENC-210309 AD.indd 6 11/24/21 2:17 PM'