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trastuzumab deruxtecan

Enhertu · ATC code L01FD04

Key facts
Active substance
trastuzumab deruxtecan
ATC code
L01FD04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Enhertu 100 mg powder for concentrate for solution for infusion
Marketing authorisation holder
Daiichi Sankyo Europe GmbH
Information as of
2026-10-27

Key facts

Trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate carrying a topoisomerase I inhibitor (DXd). It is used in HER2-positive and HER2-low/-ultralow breast cancer, HER2-mutant NSCLC, gastric cancer and other HER2-positive solid tumours.

What it is used for

  • HER2-positive unresectable or metastatic breast cancer: first-line with pertuzumab, or monotherapy after prior anti-HER2 regimens
  • HR-positive HER2-low/-ultralow or HER2-low breast cancer after endocrine therapy or chemotherapy (details in the full text)
  • Advanced NSCLC with an activating HER2 mutation after platinum-based chemotherapy
  • Advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma after a trastuzumab-based regimen
  • Other HER2-positive (IHC3+) solid tumours with no satisfactory treatment options

Dosing

  • Breast cancer, NSCLC and other solid tumours: 5.4 mg/kg by intravenous infusion every 3 weeks (21-day cycle), also with pertuzumab
  • Gastric cancer: 6.4 mg/kg every 3 weeks
  • First infusion over 90 minutes; if well tolerated, later infusions over 30 minutes
  • Until progression or unacceptable toxicity; reduce or interrupt for ILD, neutropenia or LVEF decline per the full text
  • Must not be confused or substituted with trastuzumab or trastuzumab emtansine; HER2 status must be documented

Contraindications

  • Hypersensitivity to the active substance or excipients

Important warnings

  • Interstitial lung disease/pneumonitis, including fatal cases; report cough, dyspnoea and fever immediately for evaluation
  • Neutropenia including febrile neutropenia
  • Decreased left ventricular ejection fraction; monitor LVEF
  • Embryo-foetal toxicity
  • Risk of mix-up with other trastuzumab products

Side effects

  • Very common: nausea, fatigue, vomiting, neutropenia, anaemia, alopecia, constipation, diarrhoea, decreased appetite
  • Also common: increased transaminases, musculoskeletal pain, thrombocytopenia, leukopenia
  • Serious: interstitial lung disease

Interactions

  • Ritonavir or itraconazole caused no clinically meaningful increase in exposure; no dose adjustment with CYP3A, OATP1B or P-gp inhibitors

Pregnancy and breastfeeding

  • Can cause foetal harm; women use contraception during and for at least 7 months after the last dose, men for at least 4 months
  • No breast-feeding during treatment or for 7 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 →

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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)

  • EnhertuDaiichi Sankyo Europe GmbH · EMEA/H/C/005124

Source: European Medicines Agency (EMA), product information

Turkey

  • EnhertuDAİİCHİ SANKYO İLAÇ TİC. LTD. ŞTİ. · 1 register entry

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

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

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

Sources

  1. European Medicines Agency. Enhertu – EPAR, Product Information (OF THE TEXT {DD month YYYY} Detailed information on this med). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/enhertu-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.