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nemolizumab

Nemluvio · ATC code D11AH12

Key facts
Active substance
nemolizumab
ATC code
D11AH12
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen
Marketing authorisation holder
Galderma International
Information as of
2026-10-28

Key facts

Nemolizumab (Nemluvio) is a monoclonal antibody against the interleukin-31 receptor given by subcutaneous injection. It is used for atopic dermatitis and prurigo nodularis.

What it is used for

  • Moderate-to-severe atopic dermatitis in patients aged 12 years and older who are candidates for systemic therapy.
  • Moderate-to-severe prurigo nodularis in adults who are candidates for systemic therapy.

Dosing

  • Atopic dermatitis: initial dose 60 mg (two 30 mg injections), then 30 mg every 4 weeks; with clinical response after 16 weeks, maintenance 30 mg every 8 weeks.
  • Prurigo nodularis, < 90 kg: 60 mg initial dose, then 30 mg every 4 weeks.
  • Prurigo nodularis, ≥ 90 kg: 60 mg initial dose, then 60 mg every 4 weeks.
  • Consider discontinuation if there is no response after 16 weeks.
  • No dose adjustment in elderly patients or in hepatic or renal impairment.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.

Important warnings

  • Type 1 hypersensitivity including angioedema; discontinue immediately if a systemic reaction occurs.
  • Mild to moderate worsening of pre-existing asthma in prurigo nodularis, more frequent in patients > 90 kg on 60 mg every 4 weeks.
  • Complete age-appropriate vaccinations before starting; avoid live vaccines during treatment.
  • Record the product name and batch number.

Side effects

  • Common: type I hypersensitivity (1.1%, including urticaria), injection site reactions (1.2%).
  • In prurigo nodularis also: headache (7.0%), atopic dermatitis, eczema, superficial fungal infections and worsening of asthma (2.2%).
  • Uncommon: eosinophilia.

Interactions

  • Live vaccines should not be given concurrently.
  • Antibody responses to non-live vaccines (TdaP, meningococcal polysaccharide) were not negatively affected.

Pregnancy and breastfeeding

  • Limited data; as a precaution, preferably avoid use 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)

  • NemluvioGalderma International · EMEA/H/C/006149

Source: European Medicines Agency (EMA), product information

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

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.

Other substances in the same group

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Sources

  1. European Medicines Agency. Nemluvio – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/nemluvio-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.