NovoEight
Authorised
This medicine is authorised for use in the European Union
turoctocog alfa
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
NovoEight is a medicine used to treat and prevent bleeding in patients with haemophilia A an inherited bleeding disorder caused by lack of factor VIII.
The medicine contains the active substance turoctocog alfa
NovoEight can only be obtained with a prescription, and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
NovoEight is available for injection into a vein. The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as the seriousness of the haemophilia, the extent and location of the bleeding and the patient’s age and condition. For continuing treatment, the doctor may adjust the dose and frequency of injection according to the blood levels of factor VIII.
Patients or their carers may be able to inject NovoEight themselves once they have been trained.
For more information about using NovoEight, see the package leaflet or contact your doctor or pharmacist.
Patients with haemophilia A lack factor VIII, which prevents blood from clotting and can cause problems such as bleeding in the joints, muscles or internal organs. The active substance in NovoEight, turoctocog alfa, works in the same way as natural factor VIII and helps the blood to clot. NovoEight is used to correct the factor VIII deficiency by replacing the missing factor VIII, thereby giving temporary control of the bleeding disorder.
NovoEight was effective at preventing and treating bleeding episodes in two main studies involving a total of 213 patients with haemophilia A. Neither study compared NovoEight with any other medicines.
In the first study involving 150 patients aged 12 years and above, adolescents who used NovoEight to prevent bleeding had an average of 5.55 bleeding episodes per year and adults had an average of 6.68 bleeding episodes per year. When used for the treatment of spontaneous bleeding, NovoEight was rated as ‘excellent’ or ‘good’ at treating 403 of 499 of the bleeding episodes. In addition, 89.4% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
In the second study involving 63 children less than 12 years of age, children treated with NovoEight had an average of 5.33 bleeding episodes per year. NovoEight was rated as ‘excellent’ or ‘good’ at treating 116 of the 126 bleeding episodes. In addition, 95.2% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
Hypersensitivity (allergic) reactions can occur rarely with NovoEight and may in some cases progress to severe allergic reactions. Some patients may develop factor VIII inhibitors, which can cause the medicine to stop working, resulting in a loss of bleeding control. These inhibitors are antibodies that the immune system (the body’s natural defences) produces against factor VIII.
NovoEight must not be used in patients who are allergic to hamster protein.
For the full list of side effects and restrictions, see the package leaflet.
The European Medicines Agency decided that NovoEight’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency concluded that NovoEight is effective for treating and preventing bleeding episodes, with effects similar to other factor VIII products. The safety profile of NovoEight was also considered similar to other factor VIII products.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NovoEight have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of NovoEight are continuously monitored. Side effects reported with NovoEight are carefully evaluated and any necessary action taken to protect patients.
NovoEight received a marketing authorisation valid throughout the European Union on 13 November 2013.
Product information
Latest procedure affecting product information:
II/0035
01/10/2020
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- NovoEight
- Active substance
- turoctocog alfa
- International non-proprietary name (INN) or common name
- turoctocog alfa
- Therapeutic area (MeSH)
- Hemophilia A
- Anatomical therapeutic chemical (ATC) code
- B02BD02
Pharmacotherapeutic group
coagulation factor VIIITherapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.
News on NovoEight
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