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depemokimab

Exdensur · ATC code R03DX12

Key facts
Active substance
depemokimab
ATC code
R03DX12
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
EXDENSUR 100 mg solution for injection in pre-filled pen / EXDENSUR 100 mg solution for injection in pre-filled syringe
Marketing authorisation holder
GlaxoSmithKline Trading Services Limited
Information as of
2026-10-29

Key facts

Depemokimab (Exdensur) is a long-acting monoclonal antibody against interleukin-5 used as add-on treatment for severe eosinophilic asthma and severe chronic rhinosinusitis with nasal polyps.

What it is used for

  • Add-on maintenance treatment of severe asthma with type 2 inflammation (raised blood eosinophils) in adults and adolescents aged 12 years and older inadequately controlled despite high-dose inhaled corticosteroids plus another asthma controller.
  • Add-on therapy with intranasal corticosteroids in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) when systemic corticosteroids and/or surgery do not provide adequate control.

Dosing

  • Asthma (12 years and older) and CRSwNP (adults): 100 mg subcutaneously once every 6 months.
  • Long-term treatment; decide at least annually whether to continue.
  • Give a missed dose as soon as possible; if it is 1 month or more late, resume the 6-monthly schedule from that date.
  • No dose adjustment for the elderly or renal or hepatic impairment.
  • Self-injection after training is possible (abdomen or thigh).

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Hypersensitivity reactions such as anaphylaxis and angioedema, sometimes delayed (days).
  • Not for acute asthma symptoms or acute exacerbations.
  • Do not stop corticosteroids or other background treatments abruptly; reduce gradually under medical supervision.
  • Treat pre-existing helminth infections before starting therapy.

Side effects

  • Most common: local injection site reactions (2%).
  • Common: pruritus, non-allergic administration-related systemic reactions, injection site reactions.

Interactions

  • No interaction studies; the potential for interactions is considered low.

Pregnancy and breastfeeding

  • As a precaution, preferably avoid during pregnancy.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

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)

  • ExdensurGlaxoSmithKline Trading Services Limited · EMEA/H/C/006446

Source: European Medicines Agency (EMA), product information

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

EMA – Article 57 product data (EU/EEA), 2026-10-29

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

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

Sources

  1. European Medicines Agency. Exdensur – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/exdensur-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.