Futibatinib Dosage
Medically reviewed by Drugs.com. Last updated on Jul 12, 2023.
Applies to the following strengths: 4 mg (12 mg daily-dose); 4 mg (16 mg daily-dose); 4 mg (20 mg daily-dose)
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Cholangiocarcinoma of biliary tract
Usual dose: 20 mg (five 4 mg tablets) taken orally once daily
Comments:
- Confirm the presence of an FGFR2 gene fusion or other rearrangement prior to initiation of treatment.
- Treatment to be continued until disease progression or unacceptable toxicity occurs.
Use: Patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
DOSE MODIFICATION FOR ADVERSE REACTIONS:
- First dose reduction: 16 mg (four 4 mg tablets) orally once daily
- Second dose reduction: 12 mg (three 4 mg tablets) orally once daily
- Permanently discontinue this drug if unable to tolerate 12 mg orally once daily.
DOSE MODIFICATION FOR RETINAL PIGMENT EPITHELIAL DETACHMENT (RPED):
- Continue this drug at the current dose and continue periodic ophthalmic evaluation:
- If resolved within 14 days, continue this drug at the current dose.
- If not resolved within 14 days, withhold this drug until resolved; then resume at previous or a lower dose.
DOSE MODIFICATION FOR HYPERPHOSPHATEMIA:
Serum phosphate 5.5 to 7 mg/dL:
- Continue this drug at the current dose and start with phosphate lowering therapy.
- Monitor serum phosphate weekly.
Serum phosphate more than 7 to 10 mg/dL:
- Initiate or adjust phosphate lowering therapy and monitor serum phosphate weekly.
- If the serum phosphate resolves to 7 mg/dL or less within 2 weeks after dose reduction, continue at this reduced dose.
- If serum phosphate is not 7 mg/dL or below within 2 weeks, further reduce to the next lower dose.
- If serum phosphate is not 7 mg/dL or below within 2 weeks after the second dose reduction, withhold this drug until serum phosphate is 7 mg/dL or below and resume at the dose prior to suspending.
Serum phosphate more than 10 mg/dL:
- Initiate or adjust phosphate lowering therapy and monitor serum phosphate weekly.
- Withhold this drug until phosphate is 7 mg/dL or below and resume at the next lower dose.
- Permanently discontinue this drug if serum phosphate is not equal to or less than 7 mg/dL within 2 weeks following 2 dose interruptions and reductions.
DOSE MODIFICATION FOR OTHER ADVERSE REACTIONS:
Grade 3:
- Withhold this drug until toxicity resolves to Grade 1 or baseline, then resume.
- For hematological toxicities that get resolved within 1 week, continue at the dose prior to suspending.
- For other adverse reactions, continue at next lower dose.
Grade 4:
- Permanently discontinue this drug.
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Administer this drug with or without food at approximately the same time each day.
- Swallow tablets whole. Do not crush, chew, split or dissolve tablets.
- If a dose is missed for more than 12 hours or if vomiting occurs, resume dosing the next day as scheduled.
Storage requirements:
- Store tablets at room temperature 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F to 86F).
Monitoring: Patients should be monitored for hyperphosphatemia throughout the treatment.
Patient advice:
- Patients should be advised to read FDA-approved patient labeling (Patient Information).
- Patients should be informed about potential adverse reactions of this drug which include ocular toxicity, hyperphosphatemia and soft tissue mineralization and immediately reach out to a health care professional if any symptoms related to these events develop.
- Patients should use artificial tears or hydrating or lubricating eye gels to prevent or treat dry eyes.
- Inform patients that this drug may cause nail disorders.
- Notify health care provider if patient is pregnant or becomes pregnant during treatment.
- Patients should be cognizant about the risk to a fetus and potential loss of pregnancy during the treatment with this drug.
- Male and female patients should use an effective method of contraception throughout treatment with this drug and for 1 week after the last dose of this drug.
- Do not breastfeed during treatment with this drug and for 1 week after the last dose.
- Do not consume grapefruit products during treatment with this drug.
- Patients are advised to inform health care professional about all concomitant medications, including prescription medicines, over-the-counter drugs, and herbal products.
More about futibatinib
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