Section 4.4 — Special warnings and precautions for use

FGFR2 alteration testing Patients must have FGFR2 alterations confirmed by a validated companion diagnostic test before initiating treatment with Veraxanib (see section 4.1). Hyperphosphataemia Hyperphosphataemia is a class effect of FGFR inhibitors and was observed in the majority of patients in clinical trials. Serum phosphate levels should be monitored before starting treatment, monthly for the first 3 months, and periodically thereafter. Hyperphosphataemia should be managed with dietary phosphate restriction, phosphate binders, and, if required, dose modification or interruption (see section 4.2). Ocular toxicity Retinal pigment epithelial detachment (RPED) and central serous retinopathy have been observed with Veraxanib. Patients should undergo baseline ophthalmological examination before initiating treatment. Any new or worsening visual symptoms, including blurred vision, should prompt urgent ophthalmological re-evaluation. Dose modification or discontinuation may be required depending on severity. Hepatic toxicity Elevations in hepatic enzymes (ALT, AST) have been reported. Liver function tests should be performed before starting treatment and monitored every 4 weeks for the first 3 months, then periodically thereafter.