What is the administration regimen for Lonsurf (trifluridine/tipiracil)?

Lonsurf (Trifluridine/Tipiracil) Administration Regimen

Lonsurf is administered orally at a dose of 35 mg/m² twice daily (maximum 80mg per single dose) on days 1-5 and days 8-12 of each 28-day cycle, taken within 1 hour after morning and evening meals. 1

Dosing Details

• Standard dosing schedule:

  • 35 mg/m² twice daily (maximum 80mg per dose regardless of calculated BSA)
  • Days 1-5 and 8-12 of each 28-day cycle
  • Rest periods on days 6-7 and days 13-28
  • Taken orally within 1 hour after meals 1, 2

• Tablet formulation:

  • Available in two strengths: 15mg/6.14mg and 20mg/8.19mg (trifluridine/tipiracil)
  • Dosing achieved by combining tablets of different strengths to reach appropriate dose
  • Tablets should be swallowed whole 2

Administration Considerations

• Caregivers should wear gloves when handling Lonsurf tablets 2
• Hands should be washed after handling the tablets 2
• If a dose is missed or vomited, patients should not take additional doses to make up for it 2
• Store at room temperature between 68°F and 77°F (20°C and 25°C) 2

Combination Therapy Options

When used in combination with bevacizumab (preferred over trifluridine/tipiracil alone based on SUNLIGHT trial data 3):

• Standard combination schedule:
  • Trifluridine/Tipiracil: 35 mg/m² twice daily on days 1-5 and 8-12
  • Bevacizumab: 5 mg/kg intravenous infusion on day 1
  • Repeated every 28 days 1

Common Toxicities and Management

The most common adverse events requiring monitoring include:

• Hematologic toxicities: neutropenia (38%), leukopenia (21%), anemia, and thrombocytopenia 3, 4
• Gastrointestinal effects: nausea, decreased appetite, diarrhea, vomiting, abdominal pain 2, 4
• General symptoms: fatigue and weakness 2

Dose modifications may be required for managing these toxicities, with temporary interruptions in treatment or administration of granulocyte-colony stimulating factor for severe neutropenia 5, 4.

Important Clinical Considerations

• Patient adherence to the oral regimen is crucial for treatment success 6
• Over 50% of patients may require dose interruptions/delays/reductions, but discontinuation rates due to adverse events are relatively low (9%) 4
• The median number of cycles administered in real-world practice is approximately 3, with median progression-free survival of 3.2 months 7
• Lonsurf can be given before or after regorafenib or fruquintinib; no data inform the best order of these therapies 3

This administration regimen has been validated in multiple clinical trials, including the pivotal phase III RECOURSE trial that demonstrated improved overall survival compared to placebo 5.