VENETOCLAX TAB
Clinical Criteria Summary
Exclusion Criteria
- Patient unable to comply with Tumor Lysis Syndrome (TLS) prophylaxis, hydration and monitoring prior to and during ramp-up phase
- Uncontrolled systemic infection
- Unmanageable drug-drug interaction (DDI)
- Known pregnancy
- Lactating
Primary Inclusion Criteria
- Acute Myeloid Leukemia, in combination with a hypomethylating agent (i.e. decitabine, azacitidine)
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Additional Inclusion Criteria
- Care provided by a VA or VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group Performance Status of 0 - 2
Reproductive Health & Pregnancy Requirements
- For females who can become pregnant: Pregnancy must be excluded prior to receiving venetoclax
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 30 days after stopping treatment
Clinical Management & Monitoring Requirements
- Assess tumor burden for TLS risk; cytoreduction prior to initiation may be required
- Check for DDI, especially for CYP3A inhibitors which are contraindicated during ramp-up phase