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tezepelumab

Tezspire · ATC code R03DX11

Key facts
Active substance
tezepelumab
ATC code
R03DX11
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Tezspire 210 mg solution for injection in pre-filled syringe / Tezspire 210 mg solution for injection in pre-filled pen
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-28

Key facts

Tezepelumab (Tezspire) is a monoclonal antibody against thymic stromal lymphopoietin (TSLP) used as add-on treatment for severe asthma and severe chronic rhinosinusitis with nasal polyps.

What it is used for

  • Add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma inadequately controlled despite high-dose inhaled corticosteroids plus another maintenance medicine.
  • 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): 210 mg subcutaneously every 4 weeks.
  • Long-term treatment; decide at least annually whether to continue.
  • Give a missed dose as soon as possible; no double dose.
  • No dose adjustment for the elderly or renal or hepatic impairment.
  • Self-injection into the thigh or abdomen after training is possible.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Not for acute asthma exacerbations.
  • Do not stop corticosteroids abruptly; reduce gradually under medical supervision.
  • Hypersensitivity reactions (e.g. anaphylaxis, rash), sometimes delayed.
  • Treat serious infections before starting; pause therapy during a serious infection.
  • Numerical imbalance in serious cardiac events in a long-term study (no causal relationship established); consider helminth infections.

Side effects

  • Asthma: most common arthralgia (3.8%) and pharyngitis (4.1%); CRSwNP: pharyngitis (5.4%).
  • Common: rash, injection site reactions; hypersensitivity including anaphylaxis (frequency not known).

Interactions

  • No interaction studies; avoid live attenuated vaccines.
  • Common asthma medicines do not affect tezepelumab clearance.

Pregnancy and breastfeeding

  • As a precaution, preferably avoid in pregnancy unless the expected benefit outweighs the possible risk to the foetus.

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)

  • TezspireAstraZeneca AB · EMEA/H/C/005588

Source: European Medicines Agency (EMA), product information

Turkey

  • TezspireASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry

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

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

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. Tezspire – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tezspire-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.