NovoSeven

NovoSeven is a powder and solvent that are made up into a solution for injection. It contains the active substance eptacog alfa.

NovoSeven is used for the treatment and prevention of bleeding connected with surgery in the following groups of patients:

• patients with congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop ‘inhibitors’ (antibodies) against factor VIII or IX;
• patients with acquired haemophilia (a disease caused by the spontaneous development of inhibitors to factor VIII);
• patients with congenital factor-VII deficiency;
• patients with Glanzmann’s thrombasthenia (a rare bleeding disorder) who cannot be treated with a transfusion of platelets (components that help the blood to clot).

The medicine can only be obtained with a prescription.

Treatment with NovoSeven should be started under the supervision of a doctor who has experience in the treatment of haemophilia or bleeding disorders. NovoSeven is given by injection into a vein.

• In haemophilia, the dose is 90 micrograms per kilogram body weight, repeated every two to three 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 four to six hours until the bleeding is controlled.
• In Glanzmann’s thrombasthenia, the dose is 90 micrograms/kg every two hours, for a minimum of three doses.

Patients or carers may be able to give NovoSeven themselves after suitable training. See the package leaflet for the full dosing details in all uses.

The active substance in NovoSeven, eptacog alfa (activated), 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.

Eptacog alfa is not extracted from human blood but is produced by a method known as ‘recombinant DNA technology: it is made by cells that have received a gene (DNA), which makes them able to produce eptacog alfa.

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. To find out whether the medicine could be used in the home setting, the company carried out studies in 60 patients with mild to moderate bleeding episodes. NovoSeven has also been studied in patients with Glanzmann’s thrombasthenia who could not be treated with platelets.

In the largest study, which included 61 haemophilia patients with inhibitors, 84% of the 57 serious bleeds and 59% of the 38 surgical bleeds were controlled effectively with NovoSeven.

In the study in which NovoSeven was given in the home setting, 90% of the bleeding episodes were controlled effectively.

In the study of Glanzmann’s thrombasthenia, treatment with NovoSeven was successful in 74% of the bleeds (42 out of 57).

Side effects with NovoSeven are not common. However the following side effects are seen in between 1 and 10 patients in 1,000: venous thromboembolic events (problems caused by blood clots in the veins), rash, pruritus (itching), urticaria (hives), decreased therapeutic response (lack of effectiveness of treatment) and pyrexia (fever). For the full list of all side effects reported with 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 CHMP decided that NovoSeven’s benefits are greater than its risks for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in patients with congenital haemophilia, acquired haemophilia, congenital factor VII deficiency or Glanzmann’s thrombasthenia. The Committee recommended that NovoSeven be given marketing authorisation.

A risk management plan has been developed to ensure that NovoSeven is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NovoSeven, including the appropriate precautions to be followed by healthcare professionals and patients.

The European Commission granted a marketing authorisation valid throughout the European Union for NovoSeven on 23 February 1996.

For more information about treatment with NovoSeven, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.