TIPIRACIL/ TRIFLURIDINE TAB
Clinical Criteria Summary
Exclusion Criteria
- Inability to swallow/tolerate oral medications or known malabsorption condition
- Known pregnancy
- Lactating
Inclusion Criteria (All must be met)
- Care provided by a VA/VA Community Care Hematology or Oncology provider
- Goals of care and role of palliative care consult has been discussed and documented
- Eastern Cooperative Oncology Group Performance Status 0 or 1
- Adequate bone marrow function (hemoglobin ≥ 9 g/dL, Absolute Neutrophil Count ≥ 1500/mm3, platelet count ≥ 75,000/mm3)
- Adequate liver function (total bilirubin ≤ 1.5 X Upper Limit of Normal, ALT/AST ≤ 3 X ULN or ≤ 5 x ULN if liver metastases)
- Adequate renal function (CrCl > 30 mL/min)
Additional Inclusion Criteria (One must be met)
- Metastatic colon cancer previously treated with all of the following, unless contraindicated: fluoropyrimidine-oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy and if RAS wild-type, an anti-EGFR therapy
- Metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with ≥ two prior regimens including a fluoropyrimidine, a platinum, either a taxane or irinotecan and a HER2/neu-targeted agent (if HER2+), unless contraindicated
Additional Inclusion Criteria if Applicable
- For females who can become pregnant: Pregnancy must be excluded prior to receiving trifluridine-tipiracil
- For females who can become pregnant and males with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception during therapy and for at least 3 months after stopping treatment