Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia

• PO (Adults ): Monotherapy: Start with the following 5-wk venetoclax ramp-up phase: 20 mg once daily during Wk 1; then 50 mg once daily during Wk 2; then 100 mg once daily during Wk 3; then 200 mg once daily during Wk 4; then 400 mg once daily during Wk 5. After completion of ramp-up phase, continue venetoclax therapy at 400 mg once daily until disease progression or unacceptable toxicity. In combination with rituximab: Start with the following 5-wk venetoclax ramp-up phase: 20 mg once daily during Wk 1; then 50 mg once daily during Wk 2; then 100 mg once daily during Wk 3; then 200 mg once daily during Wk 4; then 400 mg once daily during Wk 5. After completion of ramp-up phase, start rituximab, which will be administered on Day 1 of each 28-day cycle for a total of 6 cycles. Continue venetoclax therapy at 400 mg once daily starting on Day 1 of Cycle 1, and continue for 24 mo (from Day 1 of Cycle 1). In combination with obinutuzumab: Start with obinutuzumab on Days 1, 2, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent 28-day cycle for a total of 6 cycles. On Day 22 of Cycle 1, start 5-wk venetoclax ramp-up phase: 20 mg once daily during Wk 1; then 50 mg once daily during Wk 2; then 100 mg once daily during Wk 3; then 200 mg once daily during Wk 4; then 400 mg once daily during Wk 5. After completion of ramp-up phase on Day 28 of Cycle 2, continue venetoclax therapy at 400 mg once daily from Day 1 of Cycle 3 until Day 28 of Cycle 12. Concurrent use of strong CYP3A inhibitors (including posaconazole) (during ramp-up phase): Contraindicated. Concurrent use of posaconazole (after ramp-up phase): ↓venetoclax dose to 70 mg once daily. Concurrent use of strong CYP3A inhibitors other than posaconazole (after ramp-up phase): ↓venetoclax dose to 100 mg once daily. Concurrent use of moderate CYP3A inhibitors or P-gp inhibitors (during or after ramp-up phase): ↓venetoclax dose by ≥50%.

Hepatic Impairment

• PO (Adults ): Severe hepatic impairment: ↓dose by 50%.

Acute Myeloid Leukemia

• PO (Adults ): In combination with azacitidine or decitabine: Start with the following venetoclax ramp-up phase: 100 mg on Day 1; then 200 mg on Day 2; then 400 mg on Day 3; then 400 mg on Day 4. After completion of ramp-up phase, continue venetoclax therapy at 400 mg once daily until disease progression or unacceptable toxicity. Start azacitidine or decitabine on Day 1. In combination with low-dose cytarabine: Start with the following venetoclax ramp-up phase: 100 mg on Day 1; then 200 mg on Day 2; then 400 mg on Day 3; then 600 mg on Day 4. After completion of ramp-up phase, continue venetoclax therapy at 600 mg once daily until disease progression or unacceptable toxicity. Start low-dose cytarabine on Day 1. Concurrent use of posaconazole: ↓venetoclax dose during ramp-up phase to 10 mg on Day 1; then 20 mg on Day 2; then 50 mg on Day 3; then 70 mg on Day 4. After completion of ramp-up phase, ↓ venetoclax dose to 70 mg once daily. Concurrent use of strong CYP3A inhibitors other than posaconazole: ↓venetoclax dose during ramp-up phase to 10 mg on Day 1; then 20 mg on Day 2; then 50 mg on Day 3; then 100 mg on Day 4. After completion of ramp-up phase, ↓ venetoclax dose to 100 mg once daily. Concurrent use of moderate CYP3A inhibitors or P-gp inhibitors: ↓venetoclax dose by ≥50% during or after completion of ramp-up phase.

Hepatic Impairment

• PO (Adults ): Severe hepatic impairment: ↓dose by 50%.