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Patients with unresectable locally advanced or metastatic cholangiocarcinoma who are to be treated with infigratinib are selected based on the presence of FGFR2 fusion or rearrangement (confirmed by an FDA-approved test).
The recommended dosage of infigratinib is 125 mg orally once daily, taken consecutively for 21 days followed by a 7-day drug holiday, forming a 28-day treatment cycle. Treatment should continue until disease progression or unacceptable toxicity occurs.
Instruct patients to take infigratinib on an empty stomach, at least 1 hour before or 2 hours after a meal, and at approximately the same time each day. Advise patients to swallow the capsule whole with water. Inform patients not to crush, chew, or dissolve the capsule.
If a patient misses a dose of infigratinib by more than 4 hours or experiences vomiting, instruct the patient to resume the normal daily dosing schedule the next day.
The recommended dose reduction schedule for adverse reactions is as follows: first dose reduction to 100 mg, second dose reduction to 75 mg, and third dose reduction to 50 mg.
The recommended dosage adjustment plans for specific adverse reactions are as follows:
Retinal Pigment Epithelial Detachment (RPED): Continue the current dose and conduct regular ophthalmological assessments. If resolution occurs within 14 days, continue the current dose; if resolution does not occur within 14 days, suspend administration until resolution, then resume treatment at the original or a reduced dose.
Hyperphosphatemia:
Serum phosphate between 5.5–7.5 mg/dL: Continue the current dose, and initiate or adjust the dose of phosphate binders according to the label, with weekly monitoring of serum phosphate.
Serum phosphate >7.5 mg/dL or a single value >9 mg/dL: Suspend administration until serum phosphate ≤5.5 mg/dL. Resume treatment at the original or a reduced dose based on the duration of hyperphosphatemia, and administer the maximum dose of phosphate binders.
Life-threatening hyperphosphatemia: Discontinue treatment permanently.
Other adverse reactions:
Grade 3: Suspend administration until the reaction resolves to ≤Grade 1, then resume treatment at a reduced dose. If no resolution occurs within 14 days, discontinue treatment permanently.
Grade 4: Discontinue treatment permanently.
Avoid concomitant use of proton pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists, or locally acting antacids with infigratinib. If concomitant use cannot be avoided: H2 receptor antagonists should be taken 2 hours before or 10 hours after infigratinib administration; locally acting antacids should be taken 2 hours before or 2 hours after infigratinib administration.
For patients with mild to moderate renal impairment, the recommended dosage of infigratinib is 100 mg orally once daily, taken consecutively for 21 days followed by a 7-day drug holiday, forming a 28-day treatment cycle.
For patients with mild hepatic impairment, the recommended dosage is 100 mg orally once daily; for patients with moderate hepatic impairment, the recommended dosage is 75 mg orally once daily. Both regimens involve consecutive administration for 21 days followed by a 7-day drug holiday, forming a 28-day treatment cycle.
FDA，2021.05
