What is it used for?
BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved 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 PD-1 or PD-L1 inhibitor therapy .BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved 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 PD-1 or PD-L1 inhibitor therapy .
Read the primary sourceThis source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.
Product details
- Active ingredient
- erdafitiniberdafitinib
- Form and strength
- TABLET, FILM COATED · 4 mg; TABLET, FILM COATED · 3 mg; TABLET, FILM COATED · 5 mgTABLET, FILM COATED · 4 mg; TABLET, FILM COATED · 3 mg; TABLET, FILM COATED · 5 mg
- Manufacturer / applicant
- JANSSEN PRODUCTS LPJANSSEN PRODUCTS LP
Tablets: 3 mg: Yellow, round biconvex, film-coated, debossed with "3" on one side; and "EF" on the other side. 4 mg: Orange, round biconvex, film-coated, debossed with "4" on one side; and "EF" on the other side. 5 …Tablets: 3 mg: Yellow, round biconvex, film-coated, debossed with "3" on one side; and "EF" on the other side. 4 mg: Orange, round biconvex, film-coated, debossed with "4" on one side; and "EF" on the other side. 5 …
Safety and clinical review
- Ocular DisordersOcular Disorders
- Hyperphosphatemia and Soft Tissue MineralizationHyperphosphatemia and Soft Tissue Mineralization
- Embryo-Fetal ToxicityEmbryo-Fetal Toxicity
Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.
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Include the brand or generic name, strength, dosage form, requested quantity and country where care is needed. You can attach a prescription when you continue.
Questions patients ask
What is Balversa used for?
BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved 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 PD-1 or PD-L1 inhibitor therapy .BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved 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 PD-1 or PD-L1 inhibitor therapy .
This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.
Which formulation of Balversa should I ask about?
TABLET, FILM COATED · 4 mg; TABLET, FILM COATED · 3 mg; TABLET, FILM COATED · 5 mgTABLET, FILM COATED · 4 mg; TABLET, FILM COATED · 3 mg; TABLET, FILM COATED · 5 mg
Read the primary sourceWhat determines the price of Balversa?
A current quote depends on the exact presentation, quantity, provider and access arrangements. A catalogue entry is not a stock or delivery promise. Medical charges are paid to the provider, separately from coordination fees.
What should I check before using Balversa?
Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.
Sources and review scope
FDA prescribing informationThis source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.