BALVERSA FILM-COATED TABLETS 4MG

JANSSEN CILAG SPA (ITALY)🇸🇬 Health Sciences Authority

Approval Date: Aug 7, 2020
Approval ID: 25d4e3be9df8bb10
Company: JANSSEN CILAG SPA (ITALY)
Type: Therapeutic

Approval Details

Approval Id: 25d4e3be9df8bb10
Drug Name: BALVERSA FILM-COATED TABLETS 4MG
Product Name: BALVERSA FILM-COATED TABLETS 4MG
Approval Number: SIN15987P
Approval Date: 2020-08-07
Registrant: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Licence Holder: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 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. <img src="/TGIF/Balversa-Table1_030125.png" alt="Balversa Dosage Table 1" /> 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. <img src="/TGIF/Balversa-Table2_030125.png" alt="Balversa Dosage Table 2" /> 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. <img src="/TGIF/Balversa-Table3_030125.png" alt="Balversa Dosage 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. <img src="/TGIF/Balversa-Table4_030125.png" alt="Balversa Dosage 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.
Route Of Administration: ORAL
Indication Info: 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.
Contraindications: Contraindications None.
Atc Code: Pending
Atc Item Name: xpending
Pharma Manufacturer Name: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.
Company Detail Path: /organization/johnson-and-johnson-international-singapore-pte-ltd

Active Ingredients

Erdafitinib

4.00 mg

ERDAFITINIB

4 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Aug 7, 2020

Approval ID

25d4e3be9df8bb10

Type

Therapeutic

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