conestat alfa
Ruconest · ATC code B06AC04
Also known as: Konestat alfa
- Key facts
- Active substance
- conestat alfa
- ATC code
- B06AC04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Ruconest 2100 Units powder for solution for injection. · Ruconest 2100 Units powder and solvent for solution for injection.
- Marketing authorisation holder
- Pharming Group N.V.
- Information as of
- 2026-10-28
Key facts
Conestat alfa (Ruconest) is a recombinant C1 esterase inhibitor obtained from the milk of transgenic rabbits, used to treat acute attacks of hereditary angioedema.
What it is used for
- Treatment of acute angioedema attacks in adults, adolescents and children aged 2 years and above with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.
Dosing
- Body weight up to 84 kg: one intravenous injection of 50 U/kg body weight.
- Body weight of 84 kg or greater: one intravenous injection of 4200 U (2 vials, 28 ml).
- If the response is insufficient, an additional dose (50 U/kg up to 4200 U) may be given after 120 minutes in adults and adolescents or after 60 minutes in children; not more than two doses within 24 hours.
- Given by a healthcare professional as a slow intravenous injection over approximately 5 minutes.
- Children 2 years and older receive the same dose per kg as adults. No dose adjustment in renal impairment; no recommendation possible in hepatic impairment.
Contraindications
- Known or suspected allergy to rabbits.
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Contains traces of rabbit protein; patients should be asked about prior exposure to rabbits and allergic symptoms before treatment.
- Hypersensitivity reactions, which can resemble angioedema attacks, cannot be excluded; patients must be closely monitored during and after administration, and emergency treatment given for anaphylaxis.
- Cross-reactivity in patients with cow's milk allergy cannot be excluded.
- Serious thromboembolic events have been reported with plasma-derived C1 esterase inhibitor products in patients with known risk factors.
Side effects
- Common: nausea (the most common adverse reaction).
- Uncommon: headache, vertigo, dizziness, hypoaesthesia, auricular swelling, throat irritation, diarrhoea, abdominal discomfort, oral paraesthesia, urticaria, anaphylaxis.
- Not known: hypersensitivity reactions.
Interactions
- Should not be administered simultaneously with tissue-type plasminogen activator (tPA).
Pregnancy and breastfeeding
- No experience in pregnancy and breast-feeding; not recommended unless the treating physician judges the benefits to outweigh the possible risks.
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.
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)
- RuconestPharming Group N.V. · EMEA/H/C/001223
Source: European Medicines Agency (EMA), product information
Turkey
- RuconestTRPHARM İLAÇ SAN. TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Ruconest
- Liechtenstein
- Ruconest
- Norway
- Ruconest
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
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Ruconest – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/ruconest-epar-product-information_en.pdf
- 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.