Infigratinib Disease Interactions

In patients with mild (total bilirubin > upper limit of normal [ULN] to 1.5 × ULN or AST > ULN) and moderate hepatic impairment (total bilirubin > 1.5 to 3 × ULN with any AST), the AUC of infigratinib plus its active metabolites (BHS697 and CQM157) was increased by 47% to 62% and 99%, respectively as compared to patients with normal hepatic function. It is recommended to reduce the dosage of infigratinib in patients with mild or moderate hepatic impairment. The effect of severe hepatic impairment (total bilirubin > 3 × ULN with any AST) on infigratinib exposure has not been assessed. Care should be exercised when using this drug in these patients as the recommended dosage of infigratinib has not been established.

The use of infigratinib can increase serum phosphate levels due to fibroblast growth factor receptor (FGFR) inhibition. It is recommended to monitor for hyperphosphatemia during treatment and initiate phosphate lowering therapy when serum phosphate level is greater than 5.5 mg/dL. Withhold, reduce the dose, or permanently discontinue treatment based on duration and severity of hyperphosphatemia.

In patients with mild (CrCl 60 to 89 mL/min) and moderate renal impairment (CrCl 30 to 59 mL/min), the AUC of infigratinib plus its active metabolites (BHS697 and CQM157) was increased by 32% and 37%, respectively as compared to patients with normal renal function. It is recommended to reduce the dosage of infigratinib in patients with mild or moderate renal impairment. The effect of infigratinib exposure in patients with severe renal impairment (CrCl < 30 mL/min) or in with end-stage renal disease receiving dialysis has not been assessed. Care should be exercised when using this drug in these patients as the recommended dosage of infigratinib has not been established.

The use of infigratinib can cause retinal pigment epithelial detachment (RPED) which may result in symptoms such as blurred vision. It is recommended to perform comprehensive ophthalmic examination including optical coherence tomography (OCT) prior to initiating treatment and at 1 month, at 3 months, and then every 3 months thereafter during treatment. Treat patients with ocular demulcents as needed for dry eyes. Withhold therapy for 14 days until resolution or as clinically appropriate and refer patients for ophthalmic evaluation immediately for onset of visual symptoms, and follow-up every 3 weeks until resolution or discontinuation of treatment.