SOTORASIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Strong CYP 3A4 Inducers
- Proton Pump Inhibitors or H2 receptor antagonist (exception: if acid-reducing therapy is required, administer sotorasib 4 hours before or 10 hours after a local antacid)
- Inability to manage CYP3A4 or P-gp substrates
- Estimated Creatinine Clearance <30 mL/min
- Moderate or Severe Hepatic Insufficiency (AST or ALT ≥2.5 X ULN [≥5 x ULN for liver metastases] or total bilirubin ≥1.5 X ULN [≥2.0 X ULN for Gilbert’s syndrome])
- Untreated brain metastases
- Pregnancy (known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Care provided by a VA/VA Community Care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Goals of care and role of Palliative Care consult discussed and documented
- Patients of child-bearing potential or with partners of child-bearing potential: counseling on contraception and risks vs. benefits provided; effective contraception used and breastfeeding avoided during therapy and for 1 week after the last dose
Additional Inclusion Criteria
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least 1 prior systemic therapy
- Monitor LFTs every 3 weeks for the first 3 months then monthly as indicated