Adults w/ locally advanced or metastatic urothelial carcinoma (mUC), that has susceptible fibroblast growth factor receptors (FGFR) 3 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.
May cause ocular disorders, including central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED). Administer dry eye prophylaxis w/ ocular demulcents for dry eye symptoms. Perform mthly ophth exam during 1st 4 mth of treatment & every 3 mth afterwards, & urgently at any time for visual symptoms. Withhold therapy when CSR occurs & permanently discontinue if it does not resolve w/in 4 wk, or if Grade 4 in severity. Monitor for hyperphosphatemia, & patients w/ or suspected to have CYP2C9*3/*3 genotype. Female & male patients w/ female partners of reproductive potential must use effective contraception during treatment, & for 1 mth after the last dose. Pregnancy & lactation. Ped patients.
Increased plasma conc w/ moderate CYP2C9 or strong CYP3A4 inhibitors. Decreased plasma conc w/ strong & moderate CYP2C9 or CYP3A4 inducers. May increase or decrease serum phosphate levels w/ other serum phosphate level-altering agents. May alter plasma conc of CYP3A4 substrates. May increase plasma conc of OCT2 & P-gp substrates.
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