BALVERSA FILM-COATED TABLETS 5MG [SIN15988P]

Product Info

BALVERSA FILM-COATED TABLETS 5MG

[SIN15988P]

Indications

BALVERSA™ is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor (FGFR) 3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy (see Pharmacodynamic Effects - Clinical studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Select patients for therapy based on a companion diagnostic for Balversa™.

Limitations of Use

BALVERSA™ is not recommended for the treatment of patients who are eligible for and have not received prior programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy.

Dosage and Administration

Dosage – Adults (≥18 years)

Recommended dose

The recommended starting dose of BALVERSA™ is 8 mg orally once daily; with individualized up-titration, based on serum phosphate concentrations and drug-related toxicity, to 9 mg daily if criteria are met (see Dosage and Administration - Dose Modifications).

Administration

Before taking BALVERSA™, patients must have confirmation of susceptible FGFR3 gene alterations as confirmed by a validated test (see Pharmacodynamic Effects - Clinical studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The tablets should be swallowed 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.

Missed dose

If a dose of BALVERSA™ is missed, it can be taken as soon as possible. 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 modifications

Individualized up-titration based on serum phosphate concentrations and drug-related toxicity

Serum phosphate (PO₄) concentrations should be assessed between 14 and 21 days after initiating treatment. Up-titrate the dose to 9 mg daily as soon as possible if that serum phosphate (PO₄) concentration is <9.0 mg/dL, and there is no drug-related toxicity. If the phosphate level is 9.0 mg/dL or higher follow the relevant dose modifications in Table 2 - Recommended dose modifications based on serum phosphate concentrations with the use of BALVERSA™ after up-titration. After day 21 the serum phosphate level should not be used to guide up-titration decision.

Dose reduction and management of adverse reactions

For possible dose reductions and management of adverse reactions see Tables 1 to 4.

Hyperphosphatemia management

Hyperphosphatemia is an expected, transient laboratory abnormality of FGFR inhibitors (see Pharmacodynamic Effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Phosphate concentrations should be monitored monthly. For elevated phosphate concentrations in patients treated with BALVERSA™ follow dose modification guidelines in Table 2. For all patients, phosphate intake should be restricted to 600–800 mg daily. For elevated phosphate concentrations (≥7.0 mg/dL) in patients treated with BALVERSA™, follow the dose modification guidelines in Table 2, and addition of a non-calcium containing phosphate binder (e.g., sevelamer carbonate) should be considered.

Eye disorder management

Prior to initiating BALVERSA™, perform a baseline ophthalmological exam including an Amsler grid test, fundoscopy, visual acuity and, if available, an optical coherence tomography (OCT).

To prevent and treat dry eyes, use artificial tear substitutes, hydrating or lubricating eye gels or ointments frequently, at least every 2 hours during waking hours. Severe treatment-related dry eye should be evaluated by an ophthalmologist.

Subsequently examine patients monthly, including an Amsler grid test, and if any abnormality is observed, follow the management guidelines in Table 3.

Dose modification for other adverse reactions

Nail, skin and mucosal changes have been observed with BALVERSA™. Follow dose modification guidelines in Table 4.

Special populations

Pediatrics (17 years of age and younger)

The safety and efficacy of erdafitinib in children have not been established. No data are available.

Elderly (65 years of age and older)

Of the 416 patients treated with BALVERSA™ in clinical studies, 45% were 65 years of age or older, and 12% were 75 years of age or older. No overall differences in safety and effectiveness were observed between elderly and younger adult patients. No specific dose adjustments are considered necessary for elderly patients (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

Based on population pharmacokinetic (PK) analyses, no dose adjustment is required for patients with mild or moderate renal impairment (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Limited data are available in patients with severe renal impairment.

Hepatic impairment

No dose adjustment is required for patients with mild or moderate hepatic impairment (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Limited data are available in patients with severe hepatic impairment.

Contraindications

None.