Precautions of Infigratinib

Ocular Toxicity

Retinal Pigment Epithelial Detachment (RPED):

Infigratinib can cause RPED. In clinical trials, the incidence of RPED was 11%, with a median time to onset of 26 days. Perform a comprehensive ophthalmologic examination, including OCT, before initiating infigratinib treatment, at month 1 and month 3 of treatment, and every 3 months thereafter. Patients who develop visual symptoms should be referred immediately for ophthalmologic evaluation.

Dry Eye:

The incidence was 29% in clinical trials. Treatment with ocular lubricants should be administered as needed.

Hyperphosphatemia and Soft Tissue Mineralization

Infigratinib can cause hyperphosphatemia, leading to soft tissue mineralization. In clinical trials, 82% of patients developed laboratory-confirmed hyperphosphatemia, with a median time to onset of 8 days. Monitor for hyperphosphatemia throughout treatment, and initiate hypophosphatemic therapy or adjust the dose of infigratinib based on serum phosphate levels.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, infigratinib may cause fetal harm when administered to pregnant women. Inform pregnant women of the potential risk to the fetus. Advise females and males of reproductive potential to use effective contraception during treatment and for 1 month after the last dose of infigratinib.

FDA，2021.05