What is Ruconest?
Ruconest is a powder for solution for injection. The active substance contained in it is conestat alfa.
What is Ruconest used for?
Ruconest is used to treat attacks of hereditary angioedema in adults (starting at 18 years of age). Patients with angioedema suffer from episodes of swelling that can occur in any part of the body, such as the face or limbs, or around the intestine, resulting in discomfort and pain. Ruconest is used in patients with hereditary angioedema related to naturally low levels of the human C1 esterase inhibitor, a protein.
The medicine can only be obtained with a prescription.
How is Ruconest used?
Treatment with Ruconest should be started under the supervision of a doctor experienced in the diagnosis and treatment of hereditary angioedema. The medicine should only be administered by a healthcare professional. Patients who have not been treated with Ruconest before should be examined to exclude the presence of antibodies against epithelial material (desquamation and hair) of rabbit in the blood; checks must therefore be negative in order to administer the medicine.
Ruconest is given by slow injection into a vein over about 5 minutes. The dose depends on the patient's body weight. Usually one injection is sufficient to treat the attack; however, a second injection is possible if the patient does not respond satisfactorily to the first one. However, no more than two injections should be administered within 24 hours.
How does Ruconest work?
The C1 esterase inhibitor protein is the main regulator of the activation of the "complement" and "contact" systems, ie those systems of blood proteins that counteract infections and cause inflammation. In patients with low levels of this protein, these two systems experience excessive activity, resulting in symptoms of angioedema. The active substance in Ruconest, conestat alfa, is a replica of the C1 esterase inhibitor protein and acts similarly to the protein naturally present in the body. Given during an angioedema attack, conestat alfa stops this excessive activity and helps improve symptoms.
Conestat alfa is produced by "recombinant DNA technology", meaning it is extracted from the milk of rabbits in which a gene has been inserted and therefore capable of producing the human protein in their milk.
How has Ruconest been studied?
The effects of Ruconest were first tested in experimental models before being studied in humans.
Ruconest has been the subject of two main studies involving a total of 73 patients with hereditary angioedema caused by low levels of the C1 esterase inhibitor protein. The patients were mostly adults. In case of attack, patients were given one of two doses of Ruconest (50 or 100 units / kg) or a placebo (a dummy treatment). Patients treated with the lower dose of Ruconest had the possibility of a second dose within 4 hours of the first. The main measure of effectiveness was how long it took to get an improvement in symptoms. The improvement was measured by the patient himself with a score from 0 to 100 corresponding to the severity of the symptoms.
What benefit has Ruconest shown during the studies?
Ruconest was more effective than placebo in improving the symptoms of angioedema attack. Patients treated with 50 and 100 units / kg of Ruconest showed the first improvements after one and two hours respectively. Patients treated with placebo began to improve after 4 hours in one study and after more than 8 hours in the other.
Most patients already had a benefit with the 50 unit / kg dose, while only 10% of patients needed a second dose. This dose showed a success rate similar to the higher dose of Ruconest.
What are the risks associated with Ruconest?
The most common side effect associated 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 should not be used in patients who may be hypersensitive (allergic) to conestat alfa or any of the other ingredients. It cannot be used in patients with a known or suspected rabbit allergy.
Why has Ruconest been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that Ruconest's benefits are greater than its risks and therefore recommended that it be given marketing authorization.
More information on Ruconest
On October 28, 2010, the European Commission issued a marketing authorization for Ruconest, valid throughout the European Union, to Pharming Group NV. The marketing authorization is valid for five years, after which it can be renewed.
For more information about treatment with Ruconest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2010.
