"Erdafitinib, the active ingredient in BALVERSA, is a kinase inhibitor. BALVERSA (erdafitinib) is supplied as 3 mg, 4 mg or 5 mg film-coated tablets for oral administration and contains the following inactive ingredients: Tablet Core: Croscarmellose sodium, Magnesium stearate (from vegetable source), Mannitol, Meglumine, and Microcrystalline Cellulose.
Film Coating: (Opadry amb II): Glycerol monocaprylocaprate Type I, Polyvinyl alcohol-partially hydrolyzed, Sodium lauryl sulfate, Talc, Titanium dioxide, Iron oxide yellow, Iron oxide red (for the orange and brown tablets only), Ferrosoferric oxide/iron oxide black (for the brown tablets only).
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ERDAFITINIB Tablets: 3 mg, 4 mg, and 5 mg.
Recommended initial dosage: 8 mg orally once daily with a dose increase to 9 mg daily if criteria are met
BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has • susceptible FGFR3 or FGFR2 genetic alterations and • progressed during or following at least one line of prior platinumcontaining chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
