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benralizumab

Fasenra · ATC code R03DX10

Key facts
Active substance
benralizumab
ATC code
R03DX10
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Fasenra 30 mg solution for injection in pre-filled syringe / Fasenra 30 mg solution for injection in pre-filled pen
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-28

Key facts

Benralizumab is a monoclonal antibody against the interleukin-5 receptor alpha (IL-5Rα) that depletes eosinophils; it is used in severe eosinophilic asthma, EGPA and hypereosinophilic syndrome (Fasenra).

What it is used for

  • Add-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
  • Add-on treatment in adults with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
  • Add-on treatment in adults and adolescents aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome (HES) without an identifiable non-haematologic secondary cause.

Dosing

  • Asthma: 30 mg subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks.
  • EGPA: 30 mg subcutaneously every 4 weeks.
  • HES (12 years and older, at least 35 kg): 30 mg subcutaneously every 4 weeks.
  • Long-term treatment; continuation should be reviewed at least annually.
  • No dose adjustment in elderly patients or in renal or hepatic impairment.
  • A missed dose should be given as soon as possible; no double dose. Self-administration after training is possible for patients with no history of anaphylaxis.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Not for treating acute asthma exacerbations.
  • Corticosteroids should not be stopped abruptly after starting; any reduction should be gradual and supervised by a physician.
  • Hypersensitivity reactions including anaphylaxis, sometimes delayed (days); discontinue permanently if they occur.
  • Treat pre-existing helminth infections before starting; if an infection does not respond, interrupt treatment until it resolves.
  • Not studied in organ- or life-threatening EGPA or life-threatening HES.

Side effects

  • Asthma: most common headache (8%) and pharyngitis (3%); in EGPA (17%) and HES (16%) the most common is headache.
  • Common: pharyngitis, hypersensitivity reactions, headache, pyrexia, injection site reactions.
  • Frequency not known: anaphylactic reaction.

Interactions

  • No interaction studies have been performed; an effect on the pharmacokinetics of other medicines is not expected.
  • Antibody responses to seasonal influenza vaccination did not appear to be affected.

Pregnancy and breastfeeding

  • As a precaution, avoid during pregnancy unless the expected benefit to the mother outweighs the risk to the foetus.
  • Breast-feeding: decide between stopping breast-feeding or the therapy based on benefit and risk.

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.

Full official text →

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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)

  • FasenraAstraZeneca AB · EMEA/H/C/004433

Source: European Medicines Agency (EMA), product information

Turkey

  • FasenraASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries

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

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

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

Sources

  1. European Medicines Agency. Fasenra – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/fasenra-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 2026-10-28 · 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.