BeneFIX 1000 IU powder and solvent for solution forinjection

BeneFIX is a powder and solvent that are mixed together to form a solution for injection. BeneFIX contains the active substance nonacog alfa.

BeneFIX is used for the treatment and prevention of bleeding in patients with haemophilia B (an inherited bleeding disorder). BeneFIX is intended for either short-term or long-term use.

The medicine can only be obtained with a prescription.

BeneFIX should be started by a doctor who has experience in the treatment of haemophilia.

BeneFIX is given by a slow injection into a vein, usually up to 4 ml per minute. BeneFIX should not be mixed with other infusion solutions or be given using a kit other than the one supplied with the medicine. The dose and the frequency of injection depend on whether BeneFIX is used to treat or prevent bleeding, or to reduce bleeding during surgery. The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery. Full details on how to calculate the dose are included in the Package Leaflet.

Patients or their carers can give injections of BeneFIX, provided that they have been trained appropriately.

The active substance in BeneFIX, nonacog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot). Patients with haemophilia B lack a protein called factor IX, which is involved in blood clotting. The lack of factor IX causes blood-clotting problems, such as bleeding in the joints, muscles and internal organs. BeneFIX is used to replace the missing factor IX. It corrects the factor IX deficiency and gives temporary control of the bleeding disorder.

Nonacog alfa is not extracted from human blood but produced by a method known as ?recombinant DNA technology?: it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor IX.

BeneFIX has been studied in previously treated patients with moderate or severe haemophilia B, as a prevention treatment, or during and after surgery. It has also been studied in patients who have not received any treatment for their haemophilia. The studies assessed the number of bleeding episodes that occurred and rated BeneFIX?s effectiveness using a scale from ?no response? to ?excellent?.

In previously treated patients, 82% of the 693 bleeding episodes treated resolved after a single infusion of BeneFIX. Out of 972 infusions, 84% were rated as bringing about ?good? or ?excellent? responses.

Side effects are not common with BeneFIX. However, the following side effects are seen in between 1 and 10 patients in 1,000: dizziness, headache, altered taste, light-headedness, nausea (feeling sick), injection site reactions (such as burning or stinging), injection site discomfort, cellulitis (inflammation of the tissues beneath the skin), phlebitis (inflammation of a vein) and the development of antibodies (inhibitors) to factor IX. If antibodies develop, BeneFIX will not work effectively, which may result in a loss of bleeding control. Hypersensitivity (allergic reactions) has occasionally been seen in patients treated with products containing factor IX. For the full list of all side effects reported with BeneFIX, see the Package Leaflet.

BeneFIX should not be used in people who may be hypersensitive (allergic) to recombinant coagulation factor IX, to any of the other ingredients, or to hamster proteins.

The CHMP decided that BeneFIX?s benefits are greater than its risks and recommended that it be given marketing authorisation.

BeneFIX was originally authorised under ?exceptional circumstances?, because limited information was available at the time of approval. As the company had supplied the additional information requested, the ?exceptional circumstances? ended on 5 May 2010.