LuciFutib (Futibatinib)

About Futibatinib

Futibatinib blocks a protein called FGFR, which may help keep cancer cells from growing and may kill them. It is a type of tyrosine kinase inhibitor.

Cholangiocarcinoma

Indicated for previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma in adults harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements

20 mg PO qDay

Continue until disease progression or unacceptable toxicity occurs

Dosage Modifications

Dose reductions for adverse reactions

• First dose reduction: 16 mg qDay
• Second dose reduction: 12 mg qDay
• Unable to tolerate 12 mg/day: Permanently discontinue

Retinal pigment epithelial detachment (RPED)

• Continue at current dose and continue periodic ophthalmic evaluation
• If RPED resolves in ≤14 days, continue at current dose
• If not resolving in ≤14 days, withhold; once resolved, resume at previous or lower dose

Hyperphosphatemia

• Serum phosphate ≥5.5 to ≤7 mg/dL: Continue at current dose and initiate phosphate-lowering therapy; monitor serum phosphate weekly

• Serum phosphate >7 to ≤10 mg/dL

  • Initiate or adjust phosphate-lowering therapy; monitor serum phosphate weekly
  • Reduce dose to next level
  • If serum phosphate is ≤7 mg/dL within 2 weeks after dose reduction, continue at this reduced dose
  • If serum phosphate is >7 mg/dL within 2 weeks, further reduce dose to the next lower level
  • If serum phosphate is >7 mg/dL within 2 weeks after second dose reduction, withhold until serum phosphate is ≤7 mg/dL and resume at dose before suspending

• Serum phosphate >10 mg/dL

  • Initiate or adjust phosphate lowering therapy and monitor serum phosphate weekly
  • Withhold until phosphate is ≤7 mg/dL and resume at next lower dose
  • Permanently discontinue if serum phosphate is >7 mg/dL within 2 weeks following 2 dose interruptions and reductions

Other adverse reactions

• Grade 3: Withhold until toxicity resolves to Grade 1 or baseline
• Resume for hematologic toxicities resolving ≤1 week, at dose before suspending
• Resume for other adverse reactions at next lower dose
• Grade 4: Permanently discontinue

Renal impairment

• Mild to moderate (creatinine clearance [CrCl] 30-89 mL/min): No dosage adjustment necessary
• Severe (CrCl 15- 29 mL/min), renal dialysis in end-stage renal disease (CrCl <15 mL/min): Not studied

Hepatic impairment

• Mild (total bilirubin ≤ULN and AST> ULN, or total bilirubin ≤1.5x ULN and any AST): No dosage adjustment necessary
• Moderate or severe (total bilirubin >1.5x ULN and any AST): Not studied