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Lonsurf

trifluridine/tipiracil
Nucleoside Metabolic Inhibitor FDA Approved 2015 Taiho Oncology
Route
Oral
Half-Life
1.4-2.1 hrs
FDA Approved
2015
Manufacturer
Taiho Oncology
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1. Indications and Usage

CRC: Refractory metastatic CRC.
Gastric/GEJ: After ≥2 prior lines.

2. Dosage and Administration

35 mg/m² orally BID with food D1-5, D8-12 of 28-day cycles.

3. Dosage Forms and Strengths

Tablets: 15 mg/6.14 mg; 20 mg/8.19 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Severe Myelosuppression: Monitor CBCs.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Anemia (77%), Neutropenia (67%), Fatigue (52%), Nausea (48%), Thrombocytopenia (42%), Decreased Appetite (39%), Diarrhea (32%), Vomiting (28%)

Anemia
77%
Neutropenia
67%
Fatigue
52%
Nausea
48%
Thrombocytopenia
42%
Decreased Appetite
39%
Diarrhea
32%
Vomiting
28%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

May alter nucleoside analogue exposure.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Trifluridine incorporates into DNA interfering with function. Tipiracil prevents trifluridine metabolism.

Pharmacokinetics

Trifluridine t½: 1.4h. Tipiracil t½: 2.1h.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
FDA-Approved Tumor Types

Lonsurf has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

External Resources
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Lonsurf. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Lonsurf (trifluridine/tipiracil) approved for?

Lonsurf (trifluridine/tipiracil) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Lonsurf (trifluridine/tipiracil) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Lonsurf (trifluridine/tipiracil) work?

Trifluridine incorporates into DNA interfering with function. Tipiracil prevents trifluridine metabolism.

What are the most common side effects?

Anemia (77%), Neutropenia (67%), Fatigue (52%), Nausea (48%), Thrombocytopenia (42%), Decreased Appetite (39%), Diarrhea (32%), Vomiting (28%) Anemia 77% Neutropenia 67% Fatigue 52% Nausea 48% Thrombocytopenia 42% Decreased Appetite 39% Diarrhea 32% Vomiting 28%