FDA label
What is Lonsurf used for?
Lonsurf contains trifluridine and tipiracil. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Lonsurf lists 2 uses: Metastatic Colorectal Cancer; Metastatic Gastric Cancer.
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Lonsurf, tablet, film coated
Indications and Usage, quoted from the label by Taiho Pharmaceutical Co., Ltd. (NDA207981). Cross-references to other label sections are left out.
Metastatic Colorectal Cancer
LONSURF, as a single agent or in combination with bevacizumab, is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
Metastatic Gastric Cancer
LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Source: DailyMed label, set id f5beed22-d71d-4c0d-8dca-2c7317d65d85, version 15, effective November 5, 2025. NDC 64842-1020, one of 2 listings for this product.
Questions
What is Lonsurf used for?
The FDA label for Lonsurf lists 2 uses: Metastatic Colorectal Cancer; Metastatic Gastric Cancer.
What drug class is Lonsurf?
FDA lists trifluridine and tipiracil in the Nucleoside Analog Antiviral and Nucleoside Metabolic Inhibitor and Thymidine Phosphorylase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Lonsurf
- Is Lonsurf a controlled substance?Federal schedule
- Generic for LonsurfFDA Orange Book
- Nucleoside Analog Antivirals listFDA drug class
- Nucleoside Metabolic Inhibitors listFDA drug class
- Thymidine Phosphorylase Inhibitors listFDA drug class
- Lonsurf Medicare Part D coverageBy plan and state
- NDC 64842-1020Lonsurf NDC record
- NDC 64842-1025Lonsurf NDC record