LONSURF (trifluridine and tipiracil)

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

Rite Aid Pharmacy Patients: All Rite Aid pharmacies nationwide are closing! Please be on the lookout for information from Rite Aid pharmacies about their bankruptcy and store closures. Call your Rite Aid pharmacy for questions about your prescriptions and new pharmacy options. WHA is here to help as well. Contact Us via Phone