Trifluridine and Tipiracil Tablets (TrifluridineTipiracil) is an oral combination preparation composed of trifluridine and tipiracil, which is widely used in the treatment of metastatic colorectal cancer and metastatic gastric cancer.
How to Use Trifluridine and Tipiracil Tablets (TrifluridineTipiracil)
Recommended Dosage Regimen
The standard dose for adult patients is 35 mg/m² per dose, taken orally twice a day with meals.
The administration cycle is Days 1-5 and Days 8-12 of each 28-day cycle.
The maximum dose shall not exceed 80 mg per dose (based on the trifluridine component).
The specific dose shall be calculated according to the body surface area and rounded to the nearest 5 mg increment.
Administration Precautions
Patients should swallow the tablets whole; chewing or crushing the tablets is not allowed.
If vomiting occurs after taking the medicine or a dose is missed, do not make up for the missed dose and directly proceed with the next scheduled dose.
Personnel handling the medicine should wear gloves and wash their hands promptly after contact.
Dosage Adjustment of Trifluridine and Tipiracil Tablets (TrifluridineTipiracil)
Adjustment Based on Hematological Toxicity
Conduct a complete blood cell count test before the start of each cycle and on Day 15.
Before starting a new cycle, the following conditions must be met:
Absolute neutrophil count ≥ 1500/mm³, or febrile neutropenia has resolved.
Platelet count ≥ 75000/mm³.
Grade 3 or 4 non-hematological adverse reactions have recovered to Grade 0 or 1.
Indications for Treatment Suspension During the Treatment Cycle
Absolute neutrophil count < 500/mm³ or febrile neutropenia.
Platelet count < 50000/mm³.
Grade 3 or 4 non-hematological adverse reactions.
Medication for Special Populations of Trifluridine and Tipiracil Tablets (TrifluridineTipiracil)
Patients with Renal Impairment
Mild or moderate renal impairment (creatinine clearance 30-89 mL/min): No dosage adjustment is required.
Severe renal impairment (creatinine clearance 15-29 mL/min): The recommended dose is 20 mg/m² twice a day.
If the dose of 20 mg/m² twice a day is not tolerated, it can be further reduced to 15 mg/m² twice a day.
End-stage renal disease: Relevant research data are lacking.
Patients with Hepatic Impairment
Mild hepatic impairment: No adjustment to the initial dose is required.
Baseline moderate or severe hepatic impairment (total bilirubin > 1.5 times the upper limit of normal value and any AST level): Trifluridine and Tipiracil Tablets should not be initiated.
Pregnant and Lactating Women
Pregnant women: Based on animal study data, Trifluridine and Tipiracil Tablets may cause embryo-fetal lethality and embryo-fetal toxicity.
Lactating women: Animal studies have shown that trifluridine, tipiracil, and their metabolites are present in breast milk.
Populations with Reproductive Potential
Women: Effective contraceptive measures should be taken during treatment and for at least 6 months after the last dose.
Men: Due to potential genotoxicity, condoms should be used during sexual intercourse with female partners of reproductive potential during treatment and for at least 3 months after the last dose.
