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Enfortumab Vedotin

Padcev · ATC code L01FX13

Key facts
Active substance
Enfortumab Vedotin
ATC code
L01FX13
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Padcev 20 mg powder for concentrate for solution for infusion / Padcev 30 mg powder for concentrate for solution for infusion
Marketing authorisation holder
Astellas Pharma Europe B.V.
Information as of
2026-10-27

Key facts

Enfortumab vedotin is a Nectin-4-directed antibody-drug conjugate used in adults with urothelial cancer and muscle invasive bladder cancer.

What it is used for

  • Resectable muscle invasive bladder cancer: with pembrolizumab as neoadjuvant and, after radical cystectomy, adjuvant treatment
  • Unresectable or metastatic urothelial cancer, first-line with pembrolizumab in patients eligible for platinum chemotherapy
  • Locally advanced or metastatic urothelial cancer as monotherapy after platinum chemotherapy and a PD-1/PD-L1 inhibitor

Dosing

  • With pembrolizumab: 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) on Days 1 and 8 of a 21-day cycle.
  • Bladder cancer: number of neoadjuvant and adjuvant cycles depends on cisplatin eligibility (see full text).
  • Monotherapy: 1.25 mg/kg (up to 125 mg) on Days 1, 8 and 15 of a 28-day cycle until progression or unacceptable toxicity.
  • Stepwise dose reduction to 1.0 mg/kg, 0.75 mg/kg and 0.5 mg/kg for adverse reactions.
  • Permanently discontinue for SJS/TEN, Grade ≥3 pneumonitis or Grade ≥3 neuropathy; no adjustment for patients ≥65 years.

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Skin reactions including fatal SJS and TEN, mainly in the first cycle; monitor from the first cycle
  • Pneumonitis/interstitial lung disease
  • Hyperglycaemia and diabetic ketoacidosis, including fatal events; monitor blood glucose before dosing
  • Peripheral neuropathy
  • Ocular disorders, mainly dry eye; infusion site extravasation

Side effects

  • With pembrolizumab: pruritus (44.2%), diarrhoea (37.1%), alopecia (35.4%), fatigue (35%), peripheral sensory neuropathy (34%)
  • With pembrolizumab: decreased appetite (31.5%), anaemia (29.1%), weight decreased (29.1%), nausea (28.5%)
  • Monotherapy: alopecia (47.7%), decreased appetite (47.2%), fatigue (46.8%), diarrhoea (39.1%)
  • Hyperglycaemia, dysgeusia, dry skin, dry eye

Interactions

  • No formal drug-drug interaction studies
  • Concomitant strong CYP3A4 inhibitors may increase exposure to the MMAE component

Pregnancy and breastfeeding

  • Can cause foetal harm; not recommended in pregnancy; contraception during and for at least 6 months after treatment, men 4 months.
  • Discontinue breast-feeding during treatment and for at least 6 months 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)

  • PadcevAstellas Pharma Europe B.V. · EMEA/H/C/005392

Source: European Medicines Agency (EMA), product information

Turkey

  • PadcevASTELLAS PHARMA İLAÇ TİC. VE SAN. A.Ş. · 2 register entries

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

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

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.

Other substances in the same group

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Sources

  1. European Medicines Agency. Padcev – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/padcev-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.