b'DO NOT RE-SIZEDO NOT RE-SIZEAd unit Project # must match this project # 000-000000US-VENC-220137Females and Males of Reproductive Potential Clinical studies of VENCLEXTA in patients with AML did not includeRef:20070720Revised:June 2022VENCLEXTA may cause fetal harm when administered to pregnant womensufficient numbers of younger adults to determine if patients 65 years ofLAB-7538 MASTER[see Use in Specific Populations].age and older respond differently from younger adults.Pregnancy 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 moreUS-VENC-220137 Contraception intensive prophylaxis and monitoring to reduce the risk of TLS when initiating treatment with VENCLEXTA [see Warnings and Precautions]. Advise females of reproductive potential to use effective contraceptionNo dose adjustment is recommended for patients with mild, moderate or during treatment with VENCLEXTA and for 30 days after the last dose.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 aunlikely to result in significant removal of venetoclax. mg/m2 basis for a 20 kg child.Manufactured and Marketed by:Geriatric Use AbbVie Inc.Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma North Chicago, IL 60064 Of the 352 patients with previously treated CLL/SLL evaluated for safetyand from 3 open-label trials of VENCLEXTA monotherapy, 57% (201/352) wereMarketed by:65 years of age and 18% (62/352) were 75 years of age. No clinicallyGenentech USA, Inc.meaningful differences in safety and effectiveness were observed betweenA Member of the Roche Groupolder and younger patients in the combination and monotherapy studies.South San Francisco, CA 94080-4990 Acute Myeloid Leukemia2016-2022 AbbVie Inc.Of the 283 patients who received VENCLEXTA with azacitidine in VIALE-A, 2016-2022 Genentech, Inc.96% were 65 years of age and 60% were 75 years of age. Of the 13 patients who received VENCLEXTA in combination with decitabine in M14-358, 100% were 65 years of age and 62% were75 years of age. Of the 142 patients who received VENCLEXTA in combination withlow-dose cytarabine in VIALE-C, 92% were 65 years of age and 57% were 75 years of age. 20070720 Venclexta PB-7.5 x 10.5(3.5).indd 4 /29/Jun2022 2:29 PM'