VENETOCLAX TAB
Clinical Criteria Summary
Exclusion Criteria
- Patient is unable to comply with intense Tumor Lysis Syndrome (TLS) monitoring & hydration requirements that begin prior to first dose and continue during ramp-up phase
- Intolerance to BOTH xanthine oxidase inhibitors AND rasburicase
- Evidence of clinically significant conditions, including:
- • Uncontrolled systemic infection
- • Active and uncontrolled autoimmune cytopenias (AIHA, ITP)
- Richter’s transformation
- Severe hepatic dysfunction (Bilirubin > 3x ULN) – has not been studied
- Severe renal impairment (Clcr < 30 ml/min)
Inclusion Criteria: CLL/SLL
- Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) with/without deletion 17p
- ANC > 1000 cells/mm3 and/or platelet count > 30,000 cells/mm3 unless bone marrow involvement
- ECOG Performance Status 0-2
- Must be on tumor lysis prophylaxis
Inclusion Criteria: AML
- Newly diagnosed Acute Myeloid Leukemia (AML)
- Age > 75 years OR not a candidate for intensive induction chemotherapy
- WBC < 25 x 109/L prior to start of therapy; cytoreduction prior to therapy may be required
- ECOG Performance Status 0-3
- Must be on tumor lysis prophylaxis
Additional/General Inclusion Criteria
- Care provided by a VA or VA purchased care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Mandatory identification of CYP3A4 inhibitors as they are contraindicated during ramp-up phase
- Mandatory assessment of tumor burden (outpatient vs. inpatient care)