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Balversa Dosage

Generic name: ERDAFITINIB 3mg
Dosage form: tablet, film coated
Drug class: Multikinase inhibitors

Medically reviewed by Drugs.com. Last updated on Feb 1, 2024.

Patient Selection

Select patients for the treatment of locally advanced or metastatic urothelial carcinoma with BALVERSA based on the presence of susceptible FGFR3genetic alterations in tumor specimens as detected by an FDA-approved companion diagnostic [see Clinical Studies (14.1)] .

Information on FDA-approved tests for the detection of FGFR3genetic alterations in urothelial cancer is available at: http://www.fda.gov/CompanionDiagnostics.

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 Dosage and Administration (2.3)].

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. Monitor phosphate levels monthly for hyperphosphatemia [see Pharmacodynamics (12.2)] .

Dose Modifications for Adverse Reactions

The recommended dose modifications for adverse reactions are listed in Table 1.

Table 1: BALVERSA Dose Reduction Schedule
Dose 1 stdose reduction 2 nddose reduction 3 rddose reduction 4 thdose reduction 5 thdose reduction
9 mg ➞
(three 3 mg tablets)		 8 mg
(two 4 mg tablets)		 6 mg
(two 3 mg tablets)		 5 mg
(one 5 mg tablet)		 4 mg
(one 4 mg tablet)		 Stop
8 mg ➞
(two 4 mg tablets)		 6 mg
(two 3 mg tablets)		 5 mg
(one 5 mg tablet)		 4 mg
(one 4 mg tablet)		 Stop

Table 2 summarizes recommendations for dose interruption, reduction, or discontinuation of BALVERSA in the management of specific adverse reactions.

Table 2: Dose Modifications for Adverse Reactions
Adverse Reaction BALVERSA Dose Modification
*
Dose adjustment graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEv5.0).
Hyperphosphatemia
In all patients, restrict phosphate intake to 600–800 mg daily.
<6.99 mg/dL Continue BALVERSA at current dose.
7–8.99 mg/dL
  • Continue BALVERSA at current dose.
  • Start phosphate binder with food until phosphate level is <7 mg/dL.
  • Reduce the dose if serum phosphate remains ≥7 mg/dL for a period of 2 months or if clinically necessary.
9–10 mg/dL
  • Withhold BALVERSA with weekly reassessments until level returns to <7 mg/dL. Then restart BALVERSA at the same dose level.
  • Start phosphate binder with food until serum phosphate level returns to <7 mg/dL.
  • Reduce the dose for serum phosphate ≥9 mg/dL for a period of 1 month or if clinically necessary.
>10 mg/dL
  • Withhold BALVERSA with weekly reassessments until level returns to <7 mg/dL. Then may restart BALVERSA at the first reduced dose level.
  • If hyperphosphatemia (≥10 mg/dL) for >2 weeks, discontinue BALVERSA permanently.
  • Medical management of symptoms as clinically relevant.
Serum phosphate with life-threatening consequences; urgent intervention indicated (e.g., dialysis)
  • Discontinue BALVERSA permanently.
Central Serous Retinopathy (CSR)
Any Withhold BALVERSA and perform an ophthalmic evaluation within 2 weeks:
  • If improving within 14 days, restart BALVERSA at the current dose.
  • If not improving within 14 days, withhold BALVERSA until improving; once improving, may resume at the next lower dose level.
Upon restarting BALVERSA, monitor for recurrence every 1 to 2 weeks for a month.
If recurs or has not improved after 4 weeks of withholding BALVERSA, consider permanent discontinuation.
Other Adverse Reactions*
Grade 3 Withhold BALVERSA until resolves to Grade 1 or baseline, then may resume dose level lower.
Grade 4 Permanently discontinue.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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