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 FGFR3 genetic alterations in tumor specimens as detected by a validated test [see Pharmacology: Pharmacodynamics: Clinical Studies 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 tolerability, including hyperphosphatemia, 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 <9.0 mg/dL and there are no ocular disorders or Grade 2 or greater adverse reactions. If the phosphate level is 9.0 mg/dL or higher follow the relevant dose modifications in Table 4. 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 4. (See Table 4.)

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Table 5 summarizes recommendations for dose interruption, reduction, or discontinuation of BALVERSA in the management of specific adverse reactions. (See Table 5.)

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Use in Specific Populations: Females and Males of Reproductive Potential: BALVERSA can cause fetal harm when administered to a pregnant woman [see Use in Pregnancy & Lactation].
Pregnancy Testing: Verify pregnancy status in females of reproductive potential prior to initiating treatment with BALVERSA.
Contraception: Females: Advise females of reproductive potential to use effective contraception during treatment with BALVERSA and for one month after the last dose.
Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with BALVERSA and for one month after the last dose.
Infertility: Females: Based on findings from animal studies, BALVERSA may impair fertility in females of reproductive potential [see Pharmacology: Toxicology: Preclinical Safety data under Actions].
Pediatric Use: Safety and effectiveness of BALVERSA in pediatric patients have not been established.
In 4 and 13-week repeat-dose toxicology studies in rats and dogs, toxicities in bone and teeth were observed at an exposure less than the human exposure (AUC) at the maximum recommended human dose. Chondroid dysplasia/metaplasia were reported in multiple bones in both species, and tooth abnormalities included abnormal/irregular denting in rats and dogs and discoloration and degeneration of odontoblasts in rats.
Geriatric Use: Of the 479 patients treated with BALVERSA in clinical studies, 40% of patients were less than 65 years old, 40% of patients were 65 years to 74 years old, and 20% were 75 years old and over.
Patients 65 years of age and older treated with BALVERSA experienced a higher incidence of adverse reactions requiring treatment discontinuation than younger patients. In clinical trials, the incidence of treatment discontinuations of BALVERSA due to adverse reactions was 10% in patients younger than 65 years, 20% in patients ages 65-74 years, and 35% in patients 75 years or older.
No overall difference in efficacy was observed between these patients and younger patients [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
CYP2C9 Poor Metabolizers: CYP2C9*3/*3 Genotype: Erdafitinib plasma concentrations are predicted to be higher in patients with the CYP2C9*3/*3 genotype. Monitor for increased adverse reactions in patients who are known or suspected to have CYP2C9*3/*3 genotype [see Pharmacology: Pharmacogenomics under Actions].