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:

Cholangiocarcinoma of biliary tract

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

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.