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mepolizumab

Nucala · ATC code R03DX09

Key facts
Active substance
mepolizumab
ATC code
R03DX09
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Nucala 100 mg solution for injection in pre-filled pen / Nucala 100 mg solution for injection in pre-filled syringe / Nucala 40 mg solution for injection in pre-filled syringe · Nucala 100 mg powder for solution for injection
Marketing authorisation holder
GlaxoSmithKline Trading Services Limited
Information as of
2026-10-27

Key facts

Mepolizumab (Nucala) is a monoclonal antibody acting on the interleukin-5 pathway. It is used as add-on treatment for severe eosinophilic asthma and other eosinophilic diseases.

What it is used for

  • Severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older (add-on)
  • Severe chronic rhinosinusitis with nasal polyps in adults, add-on to intranasal corticosteroids
  • Uncontrolled COPD with raised blood eosinophils in adults on ICS/LABA/LAMA
  • Eosinophilic granulomatosis with polyangiitis (EGPA) from 6 years
  • Inadequately controlled hypereosinophilic syndrome in adults

Dosing

  • Asthma: 12 years and older 100 mg subcutaneously every 4 weeks; children 6 to 11 years 40 mg every 4 weeks
  • CRSwNP and COPD (adults): 100 mg subcutaneously every 4 weeks
  • EGPA: 12 years and older 300 mg every 4 weeks; children 6 to 11 years ≥ 40 kg 200 mg, < 40 kg 100 mg every 4 weeks
  • Hypereosinophilic syndrome (adults): 300 mg subcutaneously every 4 weeks
  • Long-term treatment; review need at least annually; in CRSwNP consider alternatives if no response after 24 weeks

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Not for treatment of acute asthma or COPD exacerbations
  • Do not stop corticosteroids abruptly after starting; reduce gradually under physician supervision
  • Acute and delayed systemic reactions including hypersensitivity (anaphylaxis, urticaria, angioedema), possibly after long treatment
  • Treat pre-existing helminth infections before starting therapy
  • Record product name and batch number for traceability

Side effects

  • Asthma: headache (20%), injection site reactions (8%), back pain (6%)
  • EGPA: headache (32%), injection site reactions (15%), back pain (13%); systemic allergic reactions in 4%
  • Common: lower respiratory tract infection, urinary tract infection, pharyngitis, hypersensitivity reactions
  • Rare: anaphylaxis

Interactions

  • No interaction studies; potential for interactions considered low

Pregnancy and breastfeeding

  • Limited data; as a precaution preferable to avoid in pregnancy, consider only if expected benefit to the mother outweighs the risk
  • No data on excretion in human milk

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)

  • NucalaGlaxoSmithKline Trading Services Limited · EMEA/H/C/003860

Source: European Medicines Agency (EMA), product information

Turkey

  • NucalaGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 8 register entries

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

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

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. Nucala – 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/nucala-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.