SOTORASIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Strong CYP 3A4 Inducers
- Proton Pump Inhibitors or H2 receptor antagonist
- Inability to manage CYP3A4 or P-gp substrates
- Estimated Creatinine Clearance or eGFR <30 mL/min
- Severe Hepatic Insufficiency (Child-Pugh score C or NCI Organ Dysfunction Working Group classification unless with Gilbert syndrome)
- Untreated brain metastases
- Pregnancy (known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria (Indications)
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least 1 prior systemic therapy
- KRAS G12C-mutated metastatic colorectal cancer in combination with panitumumab, for patients who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Additional 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
- Counseling on treatment risks vs benefits, use of effective contraception, and avoidance of breastfeeding during and for 1 week after last treatment for females who can become pregnant and males with partners who can become pregnant
Monitoring & Administration Guidelines
- Monitor LFTs every 3 weeks for the first 3 months then monthly as indicated
- If acid-reducing therapy required, give sotorasib 4 hours before or 10 hours after administration of a local antacid