VECLADX (Venetoclax)

Venetoclax  is a medication used to treat adults with chronic lymphocytic leukemia(CLL), small lymphocytic lymphoma(SLL), or acute myeloid leukemia(AML).

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Indicated for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Dose ramp-up phase

• Administer dose according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg
• Ramp-up dosing schedule designed to gradually reduce tumor burden and decrease risk of tumor lysis syndrome
• Week 1: 20 mg PO qDay
• Week 2: 50 mg PO qDay
• Week 3: 100 mg PO qDay
• Week 4: 200 mg PO qDay
• Week 5 and beyond: 400 mg PO qDay

Monotherapy

• 400 mg PO qDay after completing the 5-week dose ramp-up schedule
• Continue until disease progression or unacceptable toxicity

Combination with obinutuzumab

• Cycle 1

  • Day 1: Obinutuzumab 100 mg IV
  • Day 2: Obinutuzumab 900 mg IV
  • Days 8 and 15: Obinutuzumab 1000 mg IV
  • Day 22: Start venetoclax according to 5-week ramp up schedule

• Cycle 2

  • Day 1: Obinutuzumab 1000 mg IV
  • Day 28: After completing the ramp-up phase on Cycle 2 Day 28, continue venetoclax 400 mg qDay from Cycle 3 Day 1 until Cycle 12 Day 28

• Cycles 3-6

  • Day 1: Obinutuzumab 1000 mg IV
  • Days 1-28: Continue venetoclax 400 mg PO qDay

• Cycles 7-12

  • Days 1-28: Continue venetoclax 400 mg PO qDay

Combination with rituximab

• Venetoclax

  • Complete 5-week ramp-up dosing to reach 400 mg PO qDay
  • Continue venetoclax 400 mg PO qDay for 24 months from Cycle 1 Day 1 of rituximab

• Rituximab

  • Initiate 375 mg/m² IV after patient has received venetoclax 400 mg/day x 7 days (ie, this will be Day 1 of Cycle 1)
  • 500 mg/m² IV on Day 1 for Cycles 2-6

Acute Myeloid Leukemia

Indicated in combination with azacitidine or decitabine or low-dose cytarabine for treatment in adults (≥75 years) who are newly-diagnosed acute myeloid leukemia (AML) or who have comorbidities that preclude use of intensive induction chemotherapy

Venetoclax dosing depends on the combination agent

Dose ramp-up phase

• Day 1: 100 mg PO qDay
• Day 2: 200 mg PO qDay
• Day 3: 400 mg PO qDay
• Day 4 and beyond (in combination with decitabine or azacitidine): 400 mg PO qDay
• Day 4 and beyond (in combination with low-dose cytarabine): 600 mg PO qDay
• In combination with decitabine, azacitidine, or low-dose cytarabine: Continue until disease progression or unacceptable toxicity

Refer to prescribing information for azacitidine, decitabine, or cytarabine for additionaldosing information