Per 15/6.14 mg FC tab Trifluridine 15 mg, tipiracil 6.14 mg. Per 20/8.19 mg FC tab Trifluridine 20 mg, tipiracil 8.19 mg
Indications/Uses
Metastatic CRC in adults previously treated w/ fluoropyrimidine-, oxaliplatin- & irinotecan-based chemotherapy, an anti-VEGF biological therapy, & if RAS wild-type, an anti-EGFR therapy. Metastatic gastric or gastroesophageal junction adenocarcinoma in adults previously treated w/ at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, & if appropriate, HER2/neu-targeted therapy.
35 mg/m2 up to a max of 80 mg per dose bd w/in 1 hr of completion of morning & evening meals on days 1-5 & days 8-12 of each 28-day cycle until disease progression or unacceptable toxicity. Round dose to the nearest 5 mg increment. Patient w/ severe renal impairment Initially 20 mg/m2 bd, reduce to 15 mg/m2 bd if not tolerated.
Should be taken with food: Take w/in 1 hr after morning & evening meals.
Special Precautions
May cause severe & life-threatening myelosuppression. Obtain CBC prior to & on day 15 of each treatment cycle & more frequently as clinically indicated. Reduce initial dose for patients w/ severe renal impairment (CrCl 15-29 mL/min). Do not initiate in patients w/ baseline moderate or severe hepatic impairment. Can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential & males w/ female partners of reproductive potential to use effective contraception during treatment & for at least 6 mth after the final dose. Advise women not to breastfeed during treatment & for 1 day following the final dose. Higher incidence of grade 3 or 4 neutropenia & thrombocytopenia, & grade 3 anemia in patients ≥65 yr.
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