Balversa Dosage/Direction for Use

Patient Selection: Select patients for the treatment of locally advanced or metastatic urothelial carcinoma with BALVERSA based on the presence of susceptible FGFR genetic alterations in tumor specimens as detected by a validated companion diagnostic [see Pharmacology: Pharmacodynamics: Clinical Studies: Urothelial Carcinoma with Susceptible FGFR Genetic Alterations under Actions].
Recommended Dosage and Schedule: The recommended starting dose of BALVERSA is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO₄) levels and tolerability at 14 to 21 days [see Dose Modifications for Adverse Reactions as follows].
Swallow tablets whole with or without food. If vomiting occurs any time after taking BALVERSA, the next dose should be taken the next day. Treatment should continue until disease progression or unacceptable toxicity occurs.
If a dose of BALVERSA is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for BALVERSA the next day. Extra tablets should not be taken to make up for the missed dose.
Dose Increase based on Serum Phosphate Levels: Assess serum phosphate levels 14 to 21 days after initiating treatment. Increase the dose of BALVERSA to 9 mg once daily if serum phosphate level is <5.5 mg/dL and there are no ocular disorders or Grade 2 or greater adverse reactions. Monitor phosphate levels monthly for hyperphosphatemia [see Pharmacology: Pharmacodynamics under Actions].
Dose Modifications for Adverse Reactions: The recommended dose modifications for adverse reactions are listed in Table 3. (See Table 3.)

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Table 4 summarizes recommendations for dose interruption, reduction, or discontinuation of BALVERSA in the management of specific adverse reactions. (See Table 4.)

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