Balversa

Adults w/ locally advanced or metastatic urothelial carcinoma w/ susceptible fibroblast growth factor receptors 3 genetic alterations whose disease has progressed on or after at least 1 line of prior systemic therapy.

Initially 8 mg (two 4-mg tab) once daily, w/ dose increase to 9 mg (three 3-mg tab) once daily based on serum phosphate levels (<9 mg/dL), tolerability at 14-21 days & no ocular disorders or ≥Grade 2 adverse reactions. Continue treatment until disease progression or unacceptable toxicity occurs. Dose reduction schedule: 9 mg (three 3-mg tab) dose 1st dose reduction: 8 mg (two 4-mg tab), 2nd dose reduction: 6 mg (two 3-mg tab), 3rd dose reduction: 5 mg (one 5-mg tab), 4th dose reduction: 4 mg (one 4-mg tab). 8 mg (two 4-mg tab) dose 1st dose reduction: 6 mg (two 3-mg tab), 2nd dose reduction: 5 mg (one 5-mg tab), 3rd dose reduction: 4 mg (one 4-mg tab).

May be taken with or without food.

Not recommended for treatment of patients who are eligible for & have not received prior programmed cell death (PD)-1 or PD-ligand 1 inhibitor therapy. Withhold or permanently discontinue treatment based on severity &/or ophthalmology exam findings. Withhold, reduce dose, or permanently discontinue treatment based on duration & severity of hyperphosphatemia. Ocular disorders including central serous retinopathy/retinal pigment epithelial detachment. Hyperphosphatemia leading to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis & vascular calcification. Monitor patients for hyperphosphatemia throughout treatment; increased adverse reactions in patients w/ known or suspected to have CYP2C9*3/*3 genotype. Administer dry eye prophylaxis w/ ocular demulcents for dry eye symptoms. Perform mthly ophthalmological exam during 1st 4 mth of treatment & every 3 mth afterwards & urgently at any time for visual symptoms. Monitor phosphate levels mthly. Restrict dietary phosphate intake (600-800 mg daily) & avoid concomitant use of agents that may increase serum phosphate levels. Consider adding an oral phosphate binder if serum phosphate level returns to <7 mg/dL. Not to drive or use machine if patients experience treatment related symptoms affecting vision. Verify pregnancy status in females of reproductive potential prior to initiating treatment. Female & male patients w/ female partners of reproductive potential must use effective contraception during treatment & for 1 mth after the last dose. May impair fertility in females of reproductive potential. Pregnancy. Not to breastfeed during treatment & for 1 mth following last dose. Potential risk to fetus. Ped patients. Elderly ≥65 yr (higher incidence of adverse reactions requiring treatment discontinuation).

Nail disorders, palmar-plantar erythrodysesthesia syndrome, dry skin, alopecia; diarrhea, stomatitis, dry mouth, constipation, nausea; dysgeusia; fatigue; decreased appetite; dry eye, central serous retinopathy, blurred vision; decreased wt; UTI; increased/decreased phosphate, increased alkaline phosphatase, ALT, AST, creatinine, Ca & K, decreased Na, Mg, Hb, leukocytes, platelet & neutrophil count.

Increased plasma conc w/ moderate CYP2C9 or strong CYP3A4 inhibitors. Decreased plasma conc w/ strong & moderate CYP3A4 inducers. May increase or decrease serum phosphate levels w/ other serum phosphate level-altering agents. Increased plasma conc of 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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