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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 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.

Other substances in the same group

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. 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.