- Details
- Description
Packaging Size:
35t/bottle
Strength:
4mg
Composition:
Futibatinib
Treatment:
Cholangiocarcinoma in adults harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions
Form:
Tablet
Brand:
LuciFutib
Quantity Unit:
4mg*35T/Bottle
Manufacturer:
Lucius Pharmaceuticals (Lao) Co.,Ltd
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
