For: Colorectal Cancer, Gastric Cancer
Lonsurf (tipiracil and trifluridine) is a thymidine phosphorylase inhibitor and nucleoside metabolic inhibitor combination indicated for the treatment of patients with previously treated metastatic colorectal cancer, and previously treated metastatic gastric or gastroesophageal junction adenocarcinoma. LONSURF- trifluridine and tipiracil hydrochloride tablet, film coated
Taiho Pharmaceutical Co., Ltd.
1 INDICATIONS AND USAGE
LONSURF is indicated for the 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 if RAS wild-type, an anti-EGFR therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
The recommended starting dose of LONSURF is 35 mg/m2 up to a maximum of 80 mg per dose (based on the trifluridine component) orally twice daily within one hour of completion of morning and evening meals on Days 1 through 5 and Days 8 through 12 of each 28-day cycle until disease progression or unacceptable toxicity. Round dose to the nearest 5 mg increment.
Do not take additional doses to make up for missed or held doses.
LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
2.2 Dose Modifications
Obtain complete blood cell counts prior to and on Day 15 of each cycle.
Do not initiate the cycle of LONSURF until:
Absolute neutrophil count (ANC) is greater than or equal to 1,500/mm3 or febrile neutropenia is resolved
Platelets are greater than or equal to 75,000/mm3
Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1
Within a treatment cycle, withhold LONSURF for any of the following:
Absolute neutrophil count (ANC) less than 500/mm3 or febrile neutropenia
Platelets less than 50,000/mm3
Grade 3 or 4 non-hematological adverse reactions
After recovery, resume LONSURF 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 greater than or equal to 1,500/mm3) or thrombocytopenia (which has recovered to greater than or equal to 75,000/mm3) that results in more than 1 week delay in start of next cycle
Non-hematologic Grade 3 or Grade 4 adverse reaction except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheal medication
A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 twice daily. Do not escalate LONSURF dose after it has been reduced.
3 DOSAGE FORMS AND STRENGTHS
LONSURF (15 mg trifluridine/6.14 mg tipiracil) is a white, biconvex, round, film-coated tablet, imprinted with '15" on one side, and '102" and '15 mg" on the other side, in gray ink.
LONSURF (20 mg trifluridine/8.19 mg tipiracil) is a pale red, biconvex, round, film-coated tablet, imprinted with '20" on one side, and '102" and '20 mg" on the other side, in gray ink.