Usual Adult Dose for Colorectal Cancer

• Initial dose: 35 mg/m2 orally 2 times a day on Days 1 through 5 and Days 8 through 12 of each 28-day cycle
• Maximum dose: 80 mg per dose (based on trifluridine component)
• Duration of therapy: Until disease progression or unacceptable toxicity

• The dose should be rounded to the nearest 5 mg increment.
• Do not initiate a cycle of this drug until absolute neutrophil count (ANC) is 1500/mm3 or greater or febrile neutropenia is resolved; platelets are 75,000/mm3 or greater; and Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1.

• Treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and an anti-EGFR therapy (if RAS wild-type).
• Treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

Usual Adult Dose for Gastric Cancer

• Initial dose: 35 mg/m2 orally 2 times a day on Days 1 through 5 and Days 8 through 12 of each 28-day cycle
• Maximum dose: 80 mg per dose (based on trifluridine component)
• Duration of therapy: Until disease progression or unacceptable toxicity

• The dose should be rounded to the nearest 5 mg increment.
• Do not initiate a cycle of this drug until absolute neutrophil count (ANC) is 1500/mm3 or greater or febrile neutropenia is resolved; platelets are 75,000/mm3 or greater; and Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1.

• Treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and an anti-EGFR therapy (if RAS wild-type).
• Treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

Renal Dose Adjustments

• Mild to moderate renal impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
• Severe renal impairment (CrCl less than 30 mL/min): Data not available

Liver Dose Adjustments

• Mild hepatic impairment: No adjustment recommended.
• Moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN and any AST): Not recommended.

Dose Adjustments

• A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 orally 2 times a day.
• The dose should not be escalated after it has been reduced.

• ANC less than 500/mm3 or febrile neutropenia
• Platelets less than 50,000/mm3
• Grade 3 or 4 nonhematologic adverse reactions

• Febrile neutropenia
• Uncomplicated Grade 4 neutropenia (which has recovered to 1500/mm3 or greater) or thrombocytopenia (which has recovered to 75,000/mm3 or greater) that results in more than 1-week delay in start of next cycle
• Nonhematologic Grade 3 or 4 adverse reaction except for Grade 3 nausea and/or

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be taken with meals.
• The tablet should be swallowed whole.
• Additional doses should not be taken to make up for missed, vomited, or held doses.
• Handling and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.

• This drug should be discarded after 30 days if stored outside of original bottle.

• This drug consists of trifluridine and tipiracil at a molar ratio of 1:0.5.
• There is no known antidote for overdose with this drug; the highest dose administered in studies was 180 mg/m2 per day.

• CBC prior to and on Day 15 of each cycle

• This drug is available in two strengths; you may receive both strength tablets to provide your prescribed dose.
• Patients and caregivers need to wear gloves or wash hands when handling this drug.