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Lonsurf Generic Name & Formulations
Legal Class
Rx
General Description
Trifluridine, tipiracil; 15mg/6.14mg, 20mg/8.19mg; tabs.
Pharmacological Class
Antineoplastic thymidine-based nucleoside analog + thymidine phosphorylase inhibitor.
How Supplied
Tabs—20, 40, 60
Manufacturer
Generic Availability
NO
Lonsurf Indications
Indications
Metastatic colorectal cancer in patients 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 or gastroesophageal junction adenocarcinoma in patients previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Lonsurf Dosage and Administration
Adult
Swallow whole. Take with food. 35mg/m2 twice daily on Days 1–5 and 8–12 of each 28-day cycle until disease progression or unacceptable toxicity; max 80mg per dose (based on trifluridine component). Dose modifications: see full labeling.
Children
Not established.
Lonsurf Contraindications
Not Applicable
Lonsurf Boxed Warnings
Not Applicable
Lonsurf Warnings/Precautions
Warnings/Precautions
Severe myelosuppression. Obtain CBC prior to and on Day 15 of each cycle, and as clinically indicated. Do not initiate cycle until ANC ≥1,500/mm3 or febrile neutropenia is resolved, platelets ≥75,000/mm3 or Grade 3/4 non-hematological adverse reactions resolved to Grade 0/1. Withhold dose if ANC <500/mm3 or febrile neutropenia, platelets <50,000/mm3, or Grade 3/4 non-hematological adverse reactions occur; upon recovery, resume at a reduced dose (see full labeling). Moderate or severe hepatic impairment: do not initiate. Severe renal impairment (CrCl <30mL/min) or ESRD: not studied. Embryo-fetal toxicity. Use effective contraception during and for ≥6 months (females) or ≥3 months (males w. female partners) after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 day after final dose).
Lonsurf Pharmacokinetics
See Literature
Lonsurf Interactions
Lonsurf Adverse Reactions
Adverse Reactions
Anemia, neutropenia, asthenia/fatigue, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, abdominal pain, pyrexia.
Lonsurf Clinical Trials
See Literature
Lonsurf Note
Not Applicable
Lonsurf Patient Counseling
See Literature
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