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Retinal Pigment Epithelial Detachment (RPED)
Futibatinib can cause RPED, which may cause symptoms such as blurred vision.
Among 318 patients who received Futibatinib across clinical trials where ophthalmologic monitoring did not routinely include optical coherence tomography (OCT), RPED occurred in 9% of patients. The median time to first onset of RPED was 40 days. RPED led to dose interruption of Futibatinib in 1.3% of patients, dose reduction in 1.6% of patients, and permanent discontinuation in 0.3% of patients.
Perform a comprehensive ophthalmological examination, including OCT of the macula, prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of Futibatinib.
Withhold or reduce the dose of Futibatinib as recommended.
Futibatinib can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification. Increases in phosphate levels are a pharmacodynamic effect of Futibatinib . Among 318 patients who received Futibatinib across clinical trials, hyperphosphatemia was reported in 88% of patients based on laboratory values above the upper limit of normal. The median time to onset of hyperphosphatemia was 5 days (range 3- 117). Phosphate binders were received by 77% of patients who received Futibatinib.
Monitor for hyperphosphatemia throughout treatment. Initiate a low phosphate diet and phosphate lowering therapy when serum phosphate level is ≥5.5 mg/dL. For serum phosphate levels >7 mg/dL, initiate or intensify phosphate lowering therapy and dose reduce, withhold, or permanently discontinue Futibatinib based on duration and severity of hyperphosphatemia.
FDA，2022.09
