Precautions of Selpercatinib

1.Ocular Toxicity

Retinal Pigment Epithelial Detachment (RPED) 

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

2.Hyperphosphatemia and Soft Tissue Mineralization

selpercatinib can cause hyperphosphatemia leading to soft tissue mineralization, cutaneous calcification, calcinosis, and non-uremic calciphylaxis. Increases in phosphate levels are a pharmacodynamic effect of selpercatinib.

3.Embryo-Fetal Toxicity

Based on findings in an animal study and its mechanism of action, selpercatinib can cause fetal harm when administered to a pregnant woman.Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with selpercatinib and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with selpercatinib and for 1 week after the last dose.

from FDA，2024.06