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.

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.

• 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.

• Continue this drug at the current dose and start with phosphate lowering therapy.
• Monitor serum phosphate weekly.

• 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.

• 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.

• 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.

• 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.

• Store tablets at room temperature 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F to 86F).

• 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.