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dupilumab

Dupixent · ATC code D11AH05

Key facts
Active substance
dupilumab
ATC code
D11AH05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Dupixent 300 mg solution for injection in pre-filled syringe / Dupixent 300 mg solution for injection in pre-filled pen · Dupixent 200 mg solution for injection in pre-filled syringe / Dupixent 200 mg solution for injection in pre-filled pen
Marketing authorisation holder
Sanofi Winthrop Industrie
Information as of
2026-10-27

Key facts

Dupilumab (Dupixent) is a monoclonal antibody that inhibits IL-4/IL-13 signalling. It is given subcutaneously for several type 2 inflammatory diseases, including atopic dermatitis and severe asthma.

What it is used for

  • Moderate-to-severe atopic dermatitis from 12 years; severe atopic dermatitis in children from 6 months
  • Severe asthma with type 2 inflammation as add-on maintenance from 6 years
  • Severe chronic rhinosinusitis with nasal polyposis (adults)
  • Prurigo nodularis; COPD with raised blood eosinophils (adults)
  • Eosinophilic esophagitis and chronic spontaneous urticaria; further indications in the full text

Dosing

  • Atopic dermatitis, adults: initial dose 600 mg, then 300 mg every other week subcutaneously
  • Atopic dermatitis, adolescents and children: weight-based doses per the tables in the full text
  • Asthma, adults and adolescents: e.g. initial 400 mg, then 200 mg every other week; other regimens depending on comorbidity
  • Atopic dermatitis: consider stopping if no response after 16 weeks
  • Other indications (CRSwNP, EoE, COPD, CSU and more) have their own regimens: see the full product information

Contraindications

  • Hypersensitivity to the active substance or any of the excipients

Important warnings

  • Not for acute asthma or COPD symptoms or exacerbations, acute bronchospasm or status asthmaticus
  • Do not stop corticosteroids abruptly; reduce gradually under physician supervision
  • Systemic hypersensitivity including anaphylaxis, angioedema and serum sickness; discontinue immediately
  • Eosinophilic pneumonia and EGPA-type vasculitis reported in asthma patients
  • Treat pre-existing helminth infections before starting

Side effects

  • Most common: injection site reactions, conjunctivitis, allergic conjunctivitis, arthralgia, oral herpes, eosinophilia
  • Rare: serum sickness, anaphylactic reaction, ulcerative keratitis

Pregnancy and breastfeeding

  • Limited data; use in pregnancy only if the potential benefit justifies the potential risk to the foetus
  • Unknown whether excreted in human milk; weigh breast-feeding against therapy

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)

  • DupixentSanofi Winthrop Industrie · EMEA/H/C/004390

Source: European Medicines Agency (EMA), product information

Turkey

  • DupixentSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 12 register entries

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

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

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. Dupixent – 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/dupixent-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.