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icatibant

Firazyr · ATC code B06AC02

Also known as: İkatibant · Brand names: Firazyr, Icatibant Hikma, Icatibant Ratiopharm®, Icatibant Stada, Icatibant Aliud Pharma Gmbh, Icatibant Amarox, Icatibant Axiromed, Icatibant Cipla, Icatibant Ethypharm, Icatibant Glenmark, Icatibant Gp Pharm, Icatibant Piramal, Icatibant Ratiopharm, Icatibant Viatris, Icatibant Zentiva …

Key facts
Active substance
icatibant
ATC code
B06AC02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Firazyr 30 mg solution for injection in pre-filled syringe
Marketing authorisation holder
Takeda Pharmaceuticals International AG
Information as of
2026-10-29

Key facts

Icatibant is a bradykinin B2 receptor antagonist. It is used for symptomatic treatment of acute attacks of hereditary angioedema (HAE) with C1-esterase-inhibitor deficiency from 2 years of age.

What it is used for

  • Symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase-inhibitor deficiency (Firazyr).

Dosing

  • Adults: a single subcutaneous injection of 30 mg, preferably in the abdomen, injected slowly.
  • If relief is insufficient or symptoms recur, a second injection may be given after 6 hours and a third after a further 6 hours; no more than 3 injections in 24 hours.
  • Children and adolescents (2 to 17 years) by body weight: 12-25 kg 10 mg (1.0 ml); 26-40 kg 15 mg (1.5 ml); 41-50 kg 20 mg (2.0 ml); 51-65 kg 25 mg (2.5 ml); > 65 kg 30 mg (3.0 ml).
  • No dose recommendation below 2 years or 12 kg. No dose adjustment in hepatic or renal impairment.
  • Self- or caregiver administration only after training and a decision by a physician experienced in HAE.

Contraindications

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

Important warnings

  • Patients with laryngeal attacks must be managed in an appropriate medical institution after injection.
  • Caution in acute ischaemic heart disease or unstable angina pectoris.
  • Caution in the weeks following a stroke.
  • In patients who have never received Firazyr, the first treatment should be given in a medical institution or under physician guidance.

Side effects

  • Very common: injection site reactions (skin irritation, swelling, pain, itching, erythema, burning) in almost all treated subjects, generally mild to moderate and transient.
  • Common: dizziness, headache, nausea, rash, erythema, pruritus, pyrexia; frequency unknown: urticaria.

Interactions

  • No CYP450 interactions are expected.
  • Co-administration with ACE inhibitors has not been studied; ACE inhibitors are contraindicated in HAE.

Pregnancy and breastfeeding

  • Use in pregnancy only if the potential benefit justifies the risk (e.g. potentially life-threatening laryngeal attacks).
  • Breast-feeding women should not breast-feed for 12 hours after treatment.

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 →

Common questions – ask Medelix

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)

  • FirazyrTakeda Pharmaceuticals International AG · EMEA/H/C/000899
  • Icatibant Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/005083

Source: European Medicines Agency (EMA), product information

Austria

  • Icatibant HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
  • Icatibant Ratiopharm®Teva B.V · 1 register entry
  • Icatibant StadaStada Arzneimittel Gmbh · 1 register entry

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

Germany

  • Icatibant Aliud Pharma GmbhAliud Pharma Gmbh · 1 register entry
  • Icatibant AmaroxAmarox Pharma Gmbh · 1 register entry
  • Icatibant AxiromedMedical Valley Invest Ab · 1 register entry
  • Icatibant CiplaCipla Europe Nv · 1 register entry
  • Icatibant EthypharmEthypharm · 1 register entry
  • Icatibant GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
  • Icatibant Gp PharmGp-Pharm S.A. · 1 register entry
  • Icatibant HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
  • Icatibant PiramalPiramal Critical Care B.V. · 1 register entry
  • Icatibant RatiopharmRatiopharm Gmbh · 1 register entry
  • Icatibant StadaStadapharm Gmbh · 1 register entry
  • Icatibant ViatrisViatris Germany Gmbh · 1 register entry
Show all 13 brand names
  • Icatibant ZentivaZentiva Pharma Gmbh · 2 register entries

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

Turkey

  • BradikantPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • EsterebanAROMA İLAÇ SAN. LTD. ŞTİ. · 1 register entry
  • FirazyrTAKEDA İLAÇ SAĞLIK SAN. TİC. LTD. ŞTİ. · 2 register entries
  • HeactCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • HericantNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • IcatinVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • IktuKOÇSEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

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

Brand names in 23 more European countries
Belgium
Icatibant Hikma Farmacêutica (Portugal) S.A., Icatibant Teva
Bulgaria
Icatibant Sandoz
Croatia
Ikatibant Alpha-Medical, Ikatibant Fresenius, Ikatibant Teva
Czechia
Icatibant Fresenius, Icatibant Universal Farma, Icatibant Zentiva
Denmark
Icatibant "viatris", Icatibant Adalvo, Icatibant Fresenius, Icatibant Glenmark, Icatibant Gp-Pharm, Icatibant Medical Valley, Icatibant Newbury, Icatibant Piramal, Icatibant Stada, Icatibant Sun, Icatibant Teva, Icatibant Universal Farma, Icatibant Zentiva
Estonia
Icatibant Auxilia, Icatibant Fresenius, Idanuz, Idisan
Finland
Icatibant Avansor, Icatibant Glenmark, Icatibant Ratiopharm, Icatibant Sandoz, Icatibant Stada, Icatibant Universal Farma, Icatibant Viatris
France
Icatibant Amarox, Icatibant Fresenius, Icatibant Hikma, Icatibant Piramal, Icatibant Viatris, Icatibant Zentiva
Hungary
Icatibant Fresenius, Icatibant Stada, Icatibant Universal Farma
Iceland
Firazyr, Icatibant Accord, Icatibant Medical Valley, Icatibant Stada
Italy
Icatibant
Latvia
Idanuz
Liechtenstein
Firazyr, Icatibant Accord
Lithuania
Idanuz
Malta
Icatibant Newbury, Idisan
Netherlands
Icatibant Ethypharm, Icatibant Glenmark, Icatibant Hikma Farmacêutica (Portugal) S.A., Icatibant Sandoz, Icatibant Teva, Icatibant Xiromed, Lcatibant Viatris
Norway
Firazyr, Icatibant, Kisilea
Poland
Icatibant Universal Farma, Idanuz, Ikatybant Ranbaxy
Portugal
Icatibant Fresenius, Icatibant Hikma Farmacêutica (Portugal) S.A.
Romania
Icatibant Stada, Icatibant Universal Farma, Icatibant Zentiva
Slovakia
Icatibant Zentiva
Spain
Icatibanto Cipla, Icatibanto Exeltis, Icatibanto Fresenius, Icatibanto Glenmark, Icatibanto Gp-Pharm, Icatibanto Hikma, Icatibanto Stada, Icatibanto Tarbis, Tivacoma
Sweden
Icatibant Avansor, Icatibant Glenmark, Icatibant Medical Valley, Icatibant Newbury, Icatibant Sandoz, Icatibant Stada, Icatibant Teva, Icatibant Universal Farma, Icatibant Viatris

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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Sources

  1. European Medicines Agency. Firazyr – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/firazyr-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

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.