What is Ruconest?
Ruconest is a powder for solution for injection. The active ingredient contained in it is conestat alfa.
What is Ruconest used for?
Ruconest is used to treat hereditary angioedema attacks in adults (from 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 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 physician experienced in the diagnosis and treatment of hereditary angioedema. The medicine should only be given by healthcare professionals. Patients who have not been treated with Ruconest before should be examined for antibodies to the material. epithelial (desquamation and hair) of rabbit in the blood; controls must therefore be negative in order to administer the medicinal product.
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 enough to treat the attack; however, a second injection is possible if the patient does not respond satisfactorily to the first. However, no more than two injections should be given in a 24 hour period.
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 fight 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 ingredient in Ruconest, conestat alfa, is a replica of the C1 esterase inhibitor protein and acts similarly to the protein naturally present in the protein. When administered during an angioedema attack, conestat alfa stops this excessive activity and helps improve symptoms.
Conestat alfa is produced by "recombinant DNA technology", which means it is extracted from the milk of rabbits in which a gene has been inserted and therefore able to produce 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 studied in 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 the event of an attack, patients were given one of the 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 option of a second dose within 4 hours of the first. The main measure of effectiveness was time needed to improve 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 symptoms during an 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 benefited from the 50 units / kg dose, while only 10% of patients needed a second dose. This dose showed a similar success rate to the higher dose of Ruconest.
What are the risks associated with Ruconest?
The most common side effect associated with Ruconest (seen in 1 to 10 patients in 100) is headache. For the full list of 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 known or suspected rabbit allergy.
Why has Ruconest been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Ruconest outweigh its risks and therefore recommended that it be given marketing authorization.
Learn more about Ruconest
On October 28, 2010, the European Commission released Pharming Group N.V. a "Marketing Authorization" for Ruconest, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For more information on Ruconest therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 07-2010.
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