Balversa

Erdafitinib

Treatment of adults w/ locally advanced or metastatic urothelial carcinoma, that has susceptible FGFR3 or FGFR2 genetic alterations, & progressed during or following at least 1 line of prior platinum-containing chemotherapy, including w/in 12 mth of neoadjuvant or adjuvant platinum-containing chemotherapy.

Initially 8 mg (two 4-mg tab) once daily, increase to 9 mg (three 3-mg tab) once daily based on serum phosphate levels & tolerability at 14-21 days.

May be taken with or without food: Swallow whole.

Risk of ocular disorders, including central serous retinopathy/retinal pigment epithelial detachment. Perform mthly ophthalmological exam during the 1st 4 mth of treatment & every 3 mth afterwards, & urgently at any time for visual symptoms. Risk of hyperphosphatemia leading to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis & vascular calcification. Monitor for hyperphosphatemia throughout treatment. Higher erdafitinib plasma conc in patients w/ CYP2C9*3/*3 genotype. No data available in patients w/ severe renal impairment. Limited data available in patients w/ severe hepatic impairment. May impair fertility in females of reproductive potential. Can cause fetal harm when administered to a pregnant woman. Female patients of reproductive potential & male patients w/ female partners of reproductive potential must use effective contraception during treatment & for 1 mth after the last dose. Lactating women must not breastfeed during treatment & for 1 mth following the last dose. Safety & effectiveness in ped patients have not been established.

Increased phosphate, stomatitis, fatigue, increased creatinine, diarrhea, dry mouth, nail disorder, increased ALT, increased alkaline phosphatase, decreased Na, decreased appetite, decreased albumin, dysgeusia, decreased Hb, dry skin, increased AST, decreased Mg, dry eye, alopecia, palmar-plantar erythrodysesthesia syndrome, constipation, decreased phosphate, abdominal pain, increased Ca, nausea, musculoskeletal pain.

Increased plasma conc w/ moderate CYP2C9 or strong CYP3A4 inhibitors. Decreased plasma conc w/ strong or moderate CYP2C9 or CYP3A4 inducers. Increased or decreased serum phosphate levels w/ other serum phosphate level-altering agents. Altered plasma conc of CYP3A4 substrates. Increased plasma conc of OCT2 or P-gp substrates.

Targeted Cancer Therapy

L01EN01 - erdafitinib ; Belongs to the class of Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.

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