Tipiracil / Trifluridine Dosage

Medically reviewed by Drugs.com. Last updated on Mar 20, 2024.

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

Comments:

• 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.

Uses:

• 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

Comments:

• 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.

Uses:

• 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.

Within a therapy cycle, withhold this drug for any of the following:

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

After recovery, therapy should be resumed after reducing the dose by 5 mg/m2/dose from the previous dose level if the following occur:

• 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

vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheals

Precautions

CONTRAINDICATIONS:

• None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

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.

Storage requirements:

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

General:

• 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.

Monitoring:

• CBC prior to and on Day 15 of each cycle

Patient advice:

• 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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