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erdafitinib

Balversa · ATC code L01EN01

Key facts
Active substance
erdafitinib
ATC code
L01EN01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Balversa 3 mg film-coated tablets / Balversa 4 mg film-coated tablets / Balversa 5 mg film-coated tablets
Marketing authorisation holder
770
Information as of
2026-10-27

Key facts

Erdafitinib is an oral fibroblast growth factor receptor (FGFR) kinase inhibitor used to treat adults with advanced urothelial carcinoma harbouring FGFR3 alterations.

What it is used for

  • Monotherapy for adults with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 alterations after at least one line of therapy containing a PD-1 or PD-L1 inhibitor

Dosing

  • FGFR3 alteration must be confirmed beforehand with an appropriate test
  • Starting dose 8 mg once daily; assess serum phosphate between days 14 and 21
  • Up-titrate to 9 mg once daily if phosphate is below 9.0 mg/dL and there is no drug-related toxicity
  • Check phosphate before the first dose and monthly; dose modifications and reduction steps for hyperphosphataemia and toxicity in the full text
  • Continue until progression or unacceptable toxicity; if vomiting occurs, take the next dose the next day
  • Severe renal or hepatic impairment: consider alternative treatment

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Ocular disorders including central serous retinopathy with visual field defects; baseline eye exam and close monitoring, especially from 65 years
  • Dry eye is common; use ocular demulcents as prophylaxis
  • Hyperphosphataemia is an expected effect; restrict phosphate intake and consider a phosphate binder
  • Nail, skin and mucosal changes and photosensitivity; withhold or reduce dose as needed

Side effects

  • Very common: hyperphosphataemia (78.5%), diarrhoea (55.5%), stomatitis (52.8%), dry mouth (39.9%), decreased appetite (31.7%)
  • Also common: anaemia, dry skin, central serous retinopathy, palmar-plantar erythrodysaesthesia, alopecia, nail changes, liver enzyme increases
  • Most common Grade 3 or higher: stomatitis (10.6%), hyponatraemia (8.8%), palmar-plantar erythrodysaesthesia (7.9%)

Interactions

  • Moderate CYP2C9 or strong CYP3A4 inhibitors (e.g. fluconazole, itraconazole) increase erdafitinib exposure and may increase toxicity
  • Further interactions in the full text

Pregnancy and breastfeeding

  • Can cause foetal harm; women must use highly effective contraception before, during and for 1 month after the last dose; men should use condoms
  • Breast-feeding should be discontinued during treatment and for 1 month after the last dose

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Turkey

  • BalversaJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 5 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Balversa
Liechtenstein
Balversa
Norway
Balversa

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Balversa – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.