What is the administration route and dosing schedule of Lonsurf (trifluridine/tipiracil)?

Administration of Lonsurf (Trifluridine/Tipiracil)

Lonsurf is administered orally at a dose of 35 mg/m² twice daily (maximum single dose 80mg) on days 1-5 and days 8-12 of each 28-day cycle. 1

Detailed Administration Protocol

Dosing Schedule

• Route: Oral administration
• Standard Dose: 35 mg/m² twice daily (maximum 80mg per dose)
• Schedule:
  • Days 1-5: Take twice daily with food
  • Days 6-7: Rest period (no medication)
  • Days 8-12: Take twice daily with food
  • Days 13-28: Rest period (no medication)
• Cycle Length: 28 days (4 weeks)

Administration Instructions

• Take Lonsurf with food 2
• Swallow tablets whole 2
• If you miss a dose or vomit after taking a dose, do not take additional doses to make up for it; contact your healthcare provider for instructions 2
• Caregivers should wear gloves when handling Lonsurf tablets 2
• Wash hands after handling the tablets 2

Alternative Regimen with Bevacizumab

Lonsurf can also be administered in combination with bevacizumab using one of two schedules:

1. Standard schedule with bevacizumab:

   • Trifluridine/Tipiracil: 35 mg/m² (maximum 80mg per dose) orally twice daily on days 1-5 and 8-12
   • Bevacizumab: 5 mg/kg intravenous infusion on day 1
   • Repeat every 28 days 1

2. Modified schedule with bevacizumab:

   • Trifluridine/Tipiracil: 35 mg/m² (maximum 80mg per dose) orally twice daily on days 1-5
   • Bevacizumab: 5 mg/kg intravenous infusion on day 1
   • Repeat every 14 days 1

Important Considerations

Monitoring and Dose Adjustments

• Regular monitoring of complete blood counts is essential as myelosuppression is common 3
• Dose reductions, temporary interruptions, or administration of granulocyte-colony stimulating factor may be necessary to manage adverse events 4
• Over 50% of patients may require dose interruptions, delays, or reductions during treatment 3

Common Side Effects

• Most common adverse events include:
  • Hematologic: neutropenia, anemia, thrombocytopenia, and leukopenia 4
  • Gastrointestinal: nausea, decreased appetite, diarrhea, vomiting, abdominal pain 2
  • General: fatigue and weakness 2

Special Populations

• Male patients should use a condom during sex with female partners who can become pregnant during treatment and for 3 months after the last dose 2
• Breastfeeding is not recommended during treatment and for 1 day after the last dose 2

Storage Information

• Store Lonsurf at room temperature between 68°F and 77°F (20°C and 25°C) 2
• If stored outside the original bottle, unused tablets should be discarded after 30 days 2

The combination of trifluridine/tipiracil with bevacizumab is preferred over trifluridine/tipiracil alone based on the SUNLIGHT trial data showing improved overall survival (10.8 vs 7.5 months) 1.