Precautions of Pemigatinib

1.Ocular Toxicity

pemigatinib can cause RPED, which may cause symptoms such as blurred vision, visual floaters, or photopsia. Clinical trials of pemigatinib did not conduct routine monitoring including optical coherence tomography (OCT) to detect asymptomatic RPED; therefore, the incidence of asymptomatic RPED with pemigatinib is unknown.

2.Hyperphosphatemia and Soft Tissue Mineralization

pemigatinibcan cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcification, calcinosis, and non-uremic calciphylaxis. Increases in phosphate levels are a pharmacodynamic effect of PEMAZYRE. Among 635 patients who received a starting dose of pemigatinib13.5 mg across clinical trials, hyperphosphatemia was reported in 93% of patients based on laboratory values above the upper limit of normal. The median time to onset of hyperphosphatemia was 8 days (range 1-169).Phosphate lowering therapy was required in 33% of patients receiving pemigatinib.

3.Embryo-Fetal Toxicity

Based on findings in an animal study and its mechanism of action, pemigatinib can cause fetal harm when administered to a pregnant woman. Oral administration of pemigatinib to pregnant rats during the period of organogenesis caused fetal malformations, fetal growth retardation, and embryo-fetal death at maternal exposures lower than the human exposure based on area under the curve (AUC) at the clinical dose of 13.5 mg.

from FDA，2022.08