Conestat alfa is a prescription medicine indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). It is available as powder for injection for intravenous use. MedsAcross supplies Conestat alfa for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks.
Source: US FDA prescribing information
C1 esterase inhibitor (C1INH) is a normal constituent of human blood and is one of the serine protease inhibitors (serpins). The primary function of C1INH is to regulate the activation of the complement and contact system pathways. Regulation of these systems is performed through the formation of complexes between the protease and the inhibitor, resulting in inactivation of both and consumption of the C1INH. C1INH exerts its inhibitory effect by irreversibly binding several proteases (target proteases) of the contact and complement systems. The effect of RUCONEST on the following target proteases was assessed in vitro: activated C1s, kallikrein, factor XIIa and factor XIa. Inhibition kinetics were found to be comparable with those observed for plasma-derived human C1INH. HAE patients have low levels of endogenous or functional C1INH.
Source: US FDA prescribing information
For intravenous use after reconstitution only. For Intravenous Use Only. Reconstitute each vial (2100 U) by adding 14 mL sterile Water for Injection per vial to obtain a solution of 150 U per mL. Administer the reconstituted solution at room temperature as a slow intravenous injection over approximately 5 minutes. Appropriately trained patients may self-administer upon recognition of an HAE attack. Recommended dose of RUCONEST for an acute attack Body weight RUCONEST Dose for Intravenous Injection Volume (mL) of Reconstituted Solution (150 U/mL) to be Administered < 84 kg 50 U per kg Body weight in kg divided by 3 ≥ 84 kg 4200 U (2 vials) 28 mL If the attack symptoms persist, an additional (second) dose can be administered at the recommended dose level. Do not exceed 4200 U per dose. No more than two doses should be administered within a 24-hour period.
Source: US FDA prescribing information
RUCONEST is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products. RUCONEST is contraindicated in patients with a history of life-threatening immediate hypersensitivity reactions to C1 esterase inhibitor preparations, including anaphylaxis. Known or suspected allergy to rabbits and rabbit-derived products. History of immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations.
Source: US FDA prescribing information
Hypersensitivity reactions, including anaphylaxis may occur. Should symptoms occur, discontinue RUCONEST and administer appropriate treatment. Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with risk factors. Monitor patients with known risk factors for TE events during and after RUCONEST administration.
Source: US FDA prescribing information
The serious adverse reaction in clinical studies of RUCONEST was anaphylaxis. The most common adverse reactions (≥ 2%) reported in all clinical trials were headache, nausea, and diarrhea. The serious adverse reaction reported in clinical trials was anaphylactic reaction. The common adverse reactions (≥ 2%) reported in clinical trials were headache, nausea, and diarrhea.
Source: US FDA prescribing information
Shelf life: 48 months when stored at 36ºF - 77ºF (2ºC - 25ºC). Do not freeze. Store in the original package in order to protect from light. Any product that has been reconstituted should be used immediately, or within 8 hours stored at 36ºF - 46ºF (2ºC - 8ºC).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Conestat alfa, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ruconest 2100 units powder for injectionIntravenous | Pharming Healthcare | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Conestat alfa and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Conestat alfa, including Ruconest.
Yes. Conestat alfa has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Conestat alfa is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Conestat alfa is classified under ATC code B06AC04 (Conestat alfa).
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