SORAFENIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Care not provided by a VA or VA purchased care (e.g., Community Care Network, Fee Basis) oncology provider
- Liver dysfunction categorized as Child-Pugh class C
- Renal dysfunction requiring hemodialysis
- Pregnancy
- Breastfeeding
Indication/Inclusion Requirements
- Unresectable or metastatic hepatocellular carcinoma (HCC)
- Other indication(s) – requires supporting evidence
HCC-Specific Clinical Parameters
- ECOG performance status 0, 1 or 2
- Liver dysfunction categorized as Child-Pugh class A or B
- Adequate hematologic function – defined as hemoglobin > 8.5 g/dL, platelet count > 60 x 109 /L
- Concomitant use of strong CYP3A4 inducers has been avoided OR if unavoidable, sorafenib dose adjustment considered
- For female patients of child-bearing potential: provided counseling on effective contraception and potential risks vs. benefits of treatment
- For male patients with female partners of child-bearing potential: provided counseling on effective contraception and potential risks vs. benefits of treatment