Precautions of Balversa

1.Ocular Disorders

Balversa can cause ocular disorders, including central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED) resulting in visual field defect.Perform monthly ophthalmological examinations during the first 4 months of treatment and every 3 months afterwards, and urgently at any time for visual symptoms. Ophthalmological examination should include assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherence tomography. 

Withhold or permanently discontinue Balversa based on severity and/or ophthalmology exam findings.

2.Hyperphosphatemia and Soft Tissue Mineralization

Monitor for hyperphosphatemia throughout treatment. Restrict dietary phosphate intake (600-800 mg daily) and avoid concomitant use of agents that may increase serum phosphate levels. 

If serum phosphate is above 7.0 mg/dL, consider adding an oral phosphate binder until serum phosphate level returns to <7.0 mg/dL.

Withhold, dose reduce, or permanently discontinue Balversa based on duration and severity of hyperphosphatemia according to Table 2.

3.Embryo-Fetal Toxicity 

Based on the mechanism of action and findings in animal reproduction studies, Balversa can cause fetal harm when administered to a pregnant woman. In an embryo-fetal toxicity study, oral administration of erdafitinib to pregnant rats during the period of organogenesis caused malformations and embryo-fetal death at maternal exposures that were less than the human exposures at the maximum human recommended dose based on area under the curve (AUC). Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with Balversa and for one month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Balversa and for one month after the last dose.

from FDA,2024.01