NovoSeven

NovoSeven can only be obtained with a prescription and treatment and should be started under the supervision of a doctor who has experience in the treatment of haemophilia or bleeding disorders. It is available as a powder and solvent that are made up into a solution to be injected into a vein.

• In haemophilia, the dose is 90 micrograms per kilogram body weight, repeated every 2 to 3 hours until the bleeding is controlled. A higher dose may be needed in children. A single dose of 270 micrograms/kg may be used in adults with a mild or moderate bleeding episode.
• In factor VII deficiency, the dose is 15 to 30 micrograms/kg every 4 to 6 hours until the bleeding is controlled.
• In Glanzmann’s thrombasthenia, the dose is 90 micrograms/kg every 2 hours, for at least three doses.

Patients or carers may be able to give NovoSeven themselves after suitable training. For more information about using NovoSeven, see the package leaflet or contact your doctor or pharmacist.

The active substance in NovoSeven, eptacog alfa, is almost identical to a human protein called factor VII. Eptacog alfa works in the same way as factor VII. In the body, factor VII is involved in blood clotting. It activates another factor called factor X, which starts the clotting process. By activating factor X, NovoSeven is able to give temporary control of the bleeding disorder.

Because factor VII acts directly on factor X, independently from factors VIII and IX, NovoSeven can be used in haemophilia patients who have developed inhibitors to factor VIII or IX. NovoSeven can also be used to replace the missing factor VII in patients with factor VII deficiency.

NovoSeven has been studied in patients with haemophilia and in patients with factor VII deficiency. The main measure of effectiveness was the number of bleeding episodes that were controlled effectively.

In a study involving 61 haemophilia patients with inhibitors, 84% of the 57 serious bleeds and 59% of the 38 surgical bleeds were controlled effectively with NovoSeven. In another study in 60 patients with mild to moderate bleeding episodes, which investigated whether NovoSeven could be used in the home setting, 90% of the bleeding episodes were controlled effectively.

Data on the use of NovoSeven in patients with Glanzmann’s thrombasthenia were obtained from a registry of patients treated with the medicine, which showed that treatment with NovoSeven was successful in 79% of the bleeding episodes (262 out of 333) and 88% of the surgeries (140 out of 159).

Side effects with NovoSeven are not common. However the following side effects may affect between 1 and 10 patients in 1,000: venous thromboembolic events (problems caused by blood clots in the veins), rash, pruritus (itching), urticaria (hives), fever and reduced effectiveness of treatment. For the full list of side effects of NovoSeven, see the package leaflet.

NovoSeven must not be used in people who are hypersensitive (allergic) to eptacog alfa, to mouse, hamster or cow proteins, or to any of the other ingredients.

The European Medicines Agency decided that NovoSeven’s benefits are greater than its risks and it can be authorised in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NovoSeven have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of NovoSeven are continuously monitored. Side effects reported with NovoSeven are carefully evaluated and any necessary action taken to protect patients.

NovoSeven received a marketing authorisation valid throughout the EU on 23 February 1996.