What is Idelvion - Albutrepenonacog alfa and what is it used for?
Idelvion is a medicine used to prevent and treat bleeding in patients with haemophilia B, an inherited bleeding disorder caused by a lack of a clotting protein called factor IX. It can be administered to patients of any age.
Because the number of patients with haemophilia B is low, the disease is considered 'rare', and Idelvion was designated an 'orphan medicine' (a medicine used in rare diseases) on 4 February 2010.
Contains the active substance albutrepenonacog alfa.
How is Idelvion - Albutrepenonacog alfa used?
Idelvion can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the treatment of haemophilia.
Idelvion is available as a powder and solvent, which when mixed together form a solution for injection into a vein. The dose and frequency of injections depend on the patient's body weight and whether Idelvion is used as a preventative or curative for bleeding, the severity of the patient's factor IX deficiency, the extent and location of the bleeding and the health condition and age of the patient. For more information on the use of the medicine, see the Summary of Product Characteristics (included in the EPAR).
How does Idelvion - Albutrepenonacog alfa work?
Patients with haemophilia B lack factor IX, a protein necessary for normal blood clotting, and as a result are easily prone to bleeding. The active substance in Idelvion, albutrepenonacog alfa, works in the body in the same way as human factor IX. It replaces the missing factor IX, helping blood to clot and allowing for temporary control of bleeding.
What benefit has Idelvion - Albutrepenonacog alfa shown during the studies?
In a study involving 80 adult and adolescent patients and another study involving 27 children under 12 years of age, Idelvion was shown to be effective in preventing bleeding and most patients had no bleeding during preventive treatment. In addition, Idelvion has been shown to be effective in treating bleeding episodes when they have occurred, with approximately 93% of bleeding episodes resolved with a single injection of Idelvion.
What is the risk associated with Idelvion - Albutrepenonacog alfa?
Hypersensitivity (allergic) reactions to Idelvion have been reported infrequently and include: swelling, burning and stinging at the injection site, chills, redness, rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, agitation, tachycardia, chest tightness and wheezing. In some cases, these reactions can manifest themselves in a severe form.
There is also a risk with factor IX medicines that some patients develop inhibitors (antibodies) against factor IX; therefore, the medicine may become ineffective, resulting in a loss of control over bleeding. Factor IX medicines can also cause problems due to the formation of blood clots in the blood vessels. For the full list of side effects reported with Idelvion, see the package leaflet.
Idelvion must not be used in patients who are hypersensitive (allergic) to the active substance or to any of the other ingredients of the medicine. It should also not be given to patients allergic to hamster proteins.
Why has Idelvion - Albutrepenonacog alfa been approved?
Studies show that Idelvion is effective in preventing and treating bleeding episodes in patients with haemophilia B and that its safety profile is comparable to that of other factor IX products. The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Idelvion's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Idelvion - Albutrepenonacog alfa?
A risk management plan has been developed to ensure that Idelvion is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Idelvion, including the appropriate precautions to be followed by healthcare professionals and patients.
More information about Idelvion - Albutrepenonacog alfa
For the complete version of Lonsurf's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Lonsurf therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
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