This document is a summary of the European public assessment report (EPAR) for Kogenate Bayer. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Kogenate Bayer.
- What is Kogenate Bayer?
Kogenate Bayer is a powder and solvent that are mixed together to make up a solution for injection. Kogenate Bayer contains the active substance human coagulation factor VIII (octocog alfa).
- What is Kogenate Bayer used for?
Kogenate Bayer is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder). Kogenate Bayer is intended for either short-term or long-term use.
The medicine can only be obtained with a prescription.
- How is Kogenate Bayer used?
Kogenate Bayer should be started by a doctor who has experience in the treatment of haemophilia.
Kogenate Bayer is given by injection into a vein lasting several minutes. The dose and frequency of injection depend on whether Kogenate Bayer 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. Kogenate Bayer can also be given continuously for up to seven days as an infusion (drip into a vein) in patients undergoing major surgery.
Full details on how to calculate the doses are included in the summary of product characteristics (also part of the EPAR).
- How does Kogenate Bayer work?
The active substance in Kogenate Bayer, human coagulation factor VIII, is a substance that helps the blood to clot. Patients with haemophilia A lack factor VIII, which causes blood clotting problems such as bleeding in the joints, muscles and internal organs. Kogenate Bayer is used to correct the factor-VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
The human coagulation factor VIII in Kogenate Bayer 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 human coagulation factor VIII.
- How has Kogenate Bayer been studied?
Kogenate Bayer is similar to another medicine that was previously authorised in the European Union (EU) called Kogenate, but it is prepared differently so that there are no human-derived proteins in the medicine. Because of this, Kogenate Bayer has been compared with Kogenate to show that the two medicines are equivalent.
Kogenate Bayer given as an injection into a vein has been studied in 66 patients who had previously been treated with recombinant human coagulation factor VIII and 61 children who had not. The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Kogenate Bayer as a continuous infusion has also been studied in 15 patients with haemophilia A undergoing major surgery. The main measure of effectiveness was the doctor’s assessment of how well bleeding was stopped.
Some patients may develop factor-VIII inhibitors, which are antibodies (proteins) that the body’s immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control. Kogenate Bayer given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
- What benefit has Kogenate Bayer shown during the studies?
In the previously treated patients, overall, 95% of bleeds responded to one or two injections of Kogenate Bayer into a vein. In the previously untreated patients, about 90% of bleeding episodes responded to treatment with one or two injections into a vein.
When given as a continuous infusion, stopping bleeding was assessed as ‘excellent’ in all 15 patients.
The data provided on immune tolerance induction in patients with inhibitors showed, that some patients benefit from the high dosage and the inhibitor could be eliminated, nevertheless the data were not considered sufficient to specifically approve the medicine for this use.
- What is the risk associated with Kogenate Bayer?
The most common side effects with Kogenate Bayer (seen in between 1 and 10 patients in 100) include the development of antibodies against factor VIII (mainly in patients who have previously not been treated with factor VIII), reactions at the infusion site and skin-associated hypersensitivity (allergic) reactions (itching, hives and rash). For the full list of all side effects reported with Kogenate Bayer, see the package leaflet.
Kogenate Bayer must not be used in people who are known to be hypersensitive (allergic) to human coagulation factor VIII or to any of the other ingredients. It must also not be used in people who are known to have allergic reactions to mouse or hamster protein.
- Why has Kogenate Bayer been approved?
The CHMP decided that Kogenate Bayer’s benefits are greater than its risks and recommended that it be given marketing authorisation.
- Other information about Kogenate Bayer
The European Commission granted a marketing authorisation valid throughout the EU for Kogenate Bayer on 4 August 2000.
For more information about treatment with Kogenate Bayer, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 13/10/2016 .
15/09/2016 Kogenate Bayer -EMEA/H/C/000275 -WS/1006
- 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.
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).
This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Changes since initial authorisation of medicine
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Kogenate Bayer : EPAR - Procedural steps taken before authorisation||SV = svenska||2006-09-08|
|Kogenate Bayer : EPAR - Scientific Discussion||SV = svenska||2006-09-08|
This medicine is approved for use in the European Union