Per 15 mg/6.14 mg FC tab Trifluridine 15 mg, tipiracil 6.14 mg. Per 20 mg/8.19 mg FC tab Trifluridine 20 mg, tipiracil 8.19 mg
Indications/Uses
Adults w/ metastatic CRC who have been previously treated w/, or not considered candidates for, therapies including fluoropyrimidine-, oxaliplatin- & irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents, & anti-epidermal growth factor receptor (EGFR) agents; metastatic gastric or gastroesophageal junction adenocarcinoma previously treated w/ at least 2 prior lines of chemotherapy including fluoropyrimidine, platinum, either taxane or irinotecan, & if appropriate, human epidermal growth factor receptor 2 (HER-2)/neu-targeted therapy.
Adult Initially 35 mg/m2 bid on Days 1-5 & 8-12 of each 28-day cycle until benefit is observed or unacceptable toxicity occurs. Max: Not to exceed 80 mg/dose. Patient w/ severe renal impairment (CrCl 15-29 mL/min) Initially 20 mg/m2 bid. 1 dose reduction to minimum dose of 15 mg/m2 bid.
Not to start treatment if ANC is <1.5 x 109/L, platelet counts are <75 x 109/L, or w/ unresolved Grade 3 or 4 non-haematological clinically relevant toxicity from prior therapies. Increased incidence of myelopsuppression eg, anaemia, neutropenia, leukopenia & thrombocytopenia GI toxicities. Closely monitor patient if serious infections occur; patient w/ nausea, vomiting, diarrhoea & other GI toxicities. Obtain complete blood cell counts prior to initiation of therapy. Monitor proteinuria prior & during therapy. Black/African American patients. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect influence on the ability to drive & use machines. Not recommended in patients w/ ESRD (CrCl <15 mL/min or requiring dialysis); baseline moderate or severe hepatic impairment (total bilirubin >1.5x ULN). Not recommended in patients w/ moderate or severe renal impairment. Women of childbearing potential & men should use highly effective contraceptives during & for 6 mth after treatment. Not to be used during pregnancy. Lactation. Ped. Elderly >75 yr.
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