NovoSeven

eptacog alfa (activated)

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is NovoSeven?

NovoSeven is a powder and solvent that are made up into a solution for injection. It contains the active substance eptacog alfa. Two formulations of NovoSeven are available: the original formulation requires refrigeration and the newer formulation can be stored at room temperature.

What is NovoSeven used for?

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.

How is NovoSeven used?

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.

NovoSeven can be administered in the home setting. See the package leaflet for the full dosing details in all uses.

How does NovoSeven work?

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 a cell that has received a gene (DNA), which makes it able to produce eptacog alfa.

How has NovoSeven been studied?

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.

The company also carried out a study in 25 healthy volunteers to show that the two formulations of NovoSeven are treated in the same way by the body.

What benefit has NovoSeven shown during the studies?

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).

What is the risk associated with NovoSeven?

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

Why has NovoSeven been approved?

The Committee for Medicinal Products for Human Use (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.

Which measures are being taken to ensure the safe use of NovoSeven?

The company that makes NovoSeven will provide doctor and patient information packs that explain the differences between the two formulations of NovoSeven, to help avoid errors when calculating doses.

Other information about NovoSeven

The European Commission granted a marketing authorisation valid throughout the European Union for NovoSeven to Novo Nordisk A/S on 23 February 1996. The marketing authorisation was renewed on 23 February 2001 and on 23 February 2006.

This EPAR was last updated on 21/11/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

24/10/2012  NovoSeven -EMEA/H/C/000074 -II/0072

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antihaemorrhagics

Therapeutic indication

NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:

• in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda units (BU);
• in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-VIII or factor-IX administration;
• in patients with acquired haemophilia;
• in patients with congenital factor-VII deficiency;
• in patients with Glanzmann's thrombasthenia with antibodies to platelet glycoprotein (GP) IIb-IIIa and / or human leucocyte antigens (HLA), and with past or present refractoriness to platelet transfusions.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents