Ruconest
Authorised
This medicine is authorised for use in the European Union
conestat alfa
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Ruconest. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ruconest.
Ruconest is a powder that is made up into a solution for injection. It contains the active substance conestat alfa.
Ruconest is used to treat attacks of hereditary angioedema in adults and adolescents. Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. Ruconest is used in patients with hereditary angioedema that is linked to naturally low levels of a protein called ‘C1 esterase inhibitor’.
The medicine can only be obtained with a prescription.
Treatment with Ruconest should be started under the supervision of a doctor with experience in diagnosing and treating hereditary angioedema. The medicine should only be given by a healthcare professional.
Ruconest is given by slow injection into a vein lasting around five minutes. The dose depends on the patient’s body weight. One injection is usually enough to treat an attack, but a second injection may be given if the patient does not improve enough after the first one. A patient should not be given more than two injections within any 24-hour period.
The C1 esterase inhibitor protein is required to control the ‘complement’ and ‘contact’ systems, collections of proteins in the blood that fight against infection and cause inflammation. Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema. The active substance in Ruconest, conestat alfa, is a copy of the C1 esterase inhibitor protein and works in the same way as the natural human protein. When it is given during an angioedema attack, conestat alfa stops this excessive activity, helping to relieve the patient’s symptoms.
Conestat alfa is produced by ‘recombinant DNA technology’: it is extracted from the milk of rabbits that have been given genes that make them able to produce the human protein in their milk.
Ruconest was studied in two main studies involving a total of 70 adults and adolescents with hereditary angioedema caused by low levels of C1 esterase inhibitor protein. When an attack occurred, the patients were given one of two doses of Ruconest (50 or 100 units/kg) or placebo (a dummy treatment). Patients receiving the lower dose of Ruconest had the option of receiving a second dose up to four hours after the first. The main measure of effectiveness was how long it took for the symptoms to start to improve. Improvement was measured by the patients rating the severity of their symptoms on a scale from 0 to 100.
Ruconest was more effective than placebo at improving the symptoms of patients having an attack of angioedema. Patients receiving Ruconest at doses of 50 units/kg and 100 units/kg started to improve after one and two hours, respectively. Patients receiving placebo started to improve after four hours in one study and after over eight hours in the other.
Most patients were successfully treated with the 50?unit/kg dose, with only around 10% of the patients needing a second dose. This dose had a similar success rate to the higher dose of Ruconest.
The most common side effect with Ruconest (seen in between 1 and 10 patients in 100) is headache. For the full list of all side effects reported with Ruconest, see the package leaflet.
Ruconest must not be used in patients with known or suspected allergy to rabbits. For the full list of restrictions, see the package leaflet.
The CHMP decided that Ruconest’s benefits are greater than its risks and recommended that it be given marketing authorisation.
A risk management plan has been developed to ensure that Ruconest is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ruconest, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that makes Ruconest will ensure that healthcare professionals who are expected to prescribe Ruconest are provided with an educational pack containing information on the proper use of the medicine and warnings about the risk of allergy. The company will also provide prescribers with an alert card for their patients.
The European Commission granted a marketing authorisation valid throughout the European Union for Ruconest on 28 October 2010.
For more information about treatment with Ruconest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IB/0090/G
29/08/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Ruconest
- Active substance
- Recombinant human C1-inhibitor
- International non-proprietary name (INN) or common name
- conestat alfa
- Therapeutic area (MeSH)
- Angioedemas, Hereditary
- Anatomical therapeutic chemical (ATC) code
- B06AC04
Pharmacotherapeutic group
- Drugs used in hereditary angioedema
- Other hematological agents
Therapeutic indication
Ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1-esterase-inhibitor deficiency.
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