Pemazyre (pemigatinib) is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma, and the presence of FGFR2 gene fusion or rearrangement must be confirmed by an FDA-approved test.

How to Use Pemazyre (Pemigatinib)

Routine Medication Regimen

(1) Dosage: The recommended dosage is 13.5 mg taken orally once daily, administered continuously for 14 days followed by a 7-day drug holiday, forming a 21-day treatment cycle.

(2) Administration Method: Swallow the tablet whole; it can be taken with or without food. It is recommended to take the drug at a fixed time every day.

(3) Treatment Course: Continue treatment until disease progression or occurrence of intolerable toxicity.

Dosage Adjustment of Pemazyre (Pemigatinib)

Dosage Adjustment for Adverse Reactions

(1) First Dose Reduction: 9 mg per day (14 days of administration + 7-day drug holiday).

(2) Second Dose Reduction: 4.5 mg per day (same cycle as above).

(3) Permanent Discontinuation: If the 4.5 mg dose cannot be tolerated, the drug must be discontinued.

Common Scenarios for Dosage Adjustment

(1) Retinopathy: When symptomatic retinal pigment epithelial detachment (RPED) occurs, the drug should be withheld; resume treatment at a reduced dose after symptoms improve.

(2) Hyperphosphatemia: When blood phosphorus level > 7 mg/dL, initiate phosphorus-lowering treatment; if blood phosphorus level > 10 mg/dL, withhold the drug and reduce the dose upon resumption.

(3) Other Grade 3 Toxicities: Withhold the drug until toxicity resolves to Grade 1, then resume at a reduced dose; Grade 4 toxicities require permanent discontinuation of the drug.

Precautions for Pemazyre (Pemigatinib) Use in Special Populations

Patients with Hepatic or Renal Impairment

(1) Mild/Moderate Hepatic Impairment: No dosage adjustment is required; for severe hepatic impairment (total bilirubin > 3 × ULN), there is no clear recommended dosage.

(2) Mild/Moderate Renal Impairment (GFR ≥ 30 mL/min): No dosage adjustment is required; severe renal impairment (GFR < 30 mL/min) requires cautious use of the drug.

Pregnant and Lactating Women

(1) Pregnancy: Pemigatinib has embryotoxicity and may cause fetal malformation or death. Pregnancy status must be confirmed before medication use; effective contraceptive measures should be taken during treatment and within 1 week after drug discontinuation.

(2) Lactation: Breastfeeding is prohibited; breastfeeding can be resumed 1 week after drug discontinuation.