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Lonsurf Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Lonsurf Indications
Indications
As a single agent or in combination with bevacizumab in 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. 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). Severe renal impairment: 20mg/m2 twice daily on Days 1–5 and 8–12 of each 28-day cycle; if unable to tolerate, may reduce to 15mg/m2 twice daily. Permanently discontinue if unable to tolerate the 15mg/m2 twice daily dose. Dose modifications for adverse reactions: see full labeling. Refer to the Prescribing Information for bevacizumab dosing information.
Children
Lonsurf Contraindications
Not Applicable
Lonsurf Boxed Warnings
Not Applicable
Lonsurf Warnings/Precautions
Warnings/Precautions
Severe myelosuppression. Obtain CBCs 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): reduce dose. 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
Absorption
Following a single oral administration of Lonsurf at 35 mg/m2 in patients with cancer, the mean time to peak plasma concentration (Tmax) of trifluridine was ~2 hours.
Distribution
Plasma protein bound: >96% (trifluridine); <8% (tipiracil).
Elimination
Renal, fecal. Half-life (at steady-state): 2.1 hours (trifluridine); 2.4 hours (tipiracil).
Lonsurf Interactions
Not Applicable
Lonsurf Adverse Reactions
Adverse Reactions
Lonsurf Clinical Trials
See Literature
Lonsurf Note
Not Applicable
Lonsurf Patient Counseling
See Literature
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