trifluridine and tipiracil (Lonsurf®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

Colorectal cancer, metastatic

  • Treatment of metastatic colorectal cancer (mCRC) in patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy (e.g., Avastin® [bevacizumab intravenous injection]), and if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy (i.e., Erbitux® [cetuximab solution for intravenous infusion], Vectibix® [panitumumab for intravenous infusion]

All of the following must be met as a condition for coverage

  • Patient has a diagnosis of metastatic colorectal cancer (mCRC) AND
  • Patient was previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy (e.g., Avastin® [bevacizumab intravenous injection]), and if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy (i.e., Erbitux® [cetuximab solution for intravenous infusion], Vectibix® [panitumumab for intravenous infusion]

This Medication is Not Approvable for the following condition(s):

  • Any condition not listed above as an approved indication

Dosing:

Adult

  • Usual dosage:  35 mg/m2 (based on the trifluridine component) twice daily on days 1 to 5 and days 8 to 12 of a 28-day cycle; continue until disease progression or unacceptable toxicity. The manufacturer recommends rounding each dose to the nearest 5 mg increment
  • Maximum dose: 80 mg/dose (based on the trifluridine component)
  • Dosage adjustment: A maximum of 3 dose reductions are allowed (to a minimum dose of 20 mg/m2). Do not re-escalate dose after it has been reduced

Hematologic toxicity

  • ANC less than 500/mm3 (uncomplicated or resulting in more than 1 week delay in the start of the next cycle) or febrile neutropenia: Interrupt therapy; following recovery to ANC of 1,500/mm3 or greater or resolution of febrile neutropenia, may resume therapy with the dose reduced by 5 mg/m2/dose from the previous dose
  • Platelets less than 50,000/mm3 (or resulting in more than 1 week delay in the start of the next cycle):
    • Interrupt therapy; following recovery to platelets of 75,000/mm3 or greater, may resume therapy with the dose reduced by 5 mg/m2/dose from the previous dose

Nonhematologic toxicity

  • Grade 3 or 4 toxicity: Interrupt therapy until recovery to grade 1 or less; following recovery, may resume with the dose reduced by 5 mg/m2/dose from the previous dose (excludes dose reduction for grade 3 nausea and/or vomiting controlled by antiemetic therapy or grade 3 diarrhea responsive to antidiarrheal treatment)

Pediatric

  • Safety and efficacy have not been established

Renal function impairment

  • Creatinine clearance 30 mL/minute or greater:   No initial dosage adjustment is necessary. Monitor closely; patients with moderate impairment (creatinine clearance [CrCl] 30 to 59 mL/minute) may experience greater toxicity and may require dose reduction during treatment
  • CrCl less than 30 mL/minute and end stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied)

Hepatic function impairment

  • Mild impairment (total bilirubin upper limit of normal or less and AST more than upper limit of normal or total bilirubin less than 1 to 1.5 × upper limit of normal and any AST): 
    • No dosage adjustment is necessary
  • Moderate (total bilirubin 1.5 to 3 × upper limit of normal and any AST) or severe (total bilirubin more than 3 × upper limit of normal and any AST): 
    • There are no dosage adjustments provided in the manufacturer's labeling (has not been studied)

Approval: 

One year


  

Last review date: July 24, 2016