Helixate NexGen

octocog alfa

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This is a summary of the European public assessment report (EPAR) for Helixate NexGen. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Helixate NexGen.

For practical information about using Helixate NexGen, patients should read the package leaflet or contact their doctor or pharmacist.

What is Helixate NexGen and what is it used for?

Helixate NexGen is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It contains the active substance octocog alfa (human coagulation factor VIII).

How is Helixate NexGen used?

Helixate NexGen can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia.

Helixate NexGen is available as a powder and solvent that are mixed together to make a solution for injection or infusion (drip) into a vein. The dose and duration of treatment depend on whether Helixate NexGen is used to treat or prevent bleeding or during surgery, as well as on the patient’s factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient’s condition and bodyweight. The dose may need to be adjusted if Helixate NexGen is to be given continuously as an infusion into a vein. Helixate NexGen is intended for either short-term or long-term use.

Patients or their carers may be able to administer Helixate NexGen themselves at home once they have been trained appropriately. For full details, see the package leaflet.

How does Helixate NexGen work?

The active substance in Helixate NexGen, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot. Patients with haemophilia A lack factor VIII, and this causes blood clotting problems such as bleeding in the joints, muscles and internal organs. Helixate NexGen is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.

Octocog alfa is made by a method known as ‘recombinant DNA technology’: it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.

What benefits of Helixate NexGen have been shown in studies?

Helixate NexGen is similar to another medicine that was previously authorised in the EU called Helixate, but it is prepared differently so that there are no human-derived proteins in the medicine. Because of this, Helixate NexGen has been compared with Helixate to show that the two medicines are equivalent.

Helixate NexGen 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. In the previously treated patients, overall, 95% of bleeds responded to one or two injections of Helixate NexGen into a vein. In the previously untreated patients, about 90% of bleeding episodes responded to treatment with one or two injections into a vein.

Helixate NexGen 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. Stopping bleeding was assessed as ‘excellent’ in all 15 patients.

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. Helixate NexGen 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. 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 are the risks associated with Helixate NexGen?

Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and may in some cases become severe. Skin- associated hypersensitivity reactions (itching, hives and rash) may occur commonly (in between 1 and 10 patients in 100) but a severe allergic reaction is rare (between 1 and 10 in 10,000 patients).

There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control. In such cases, a specialised haemophilia centre should be contacted.

For the full list of all side effects reported with Kogenate Bayer, see the package leaflet. Helixate NexGen must not be used in people who are known to be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein or to any of the other ingredients.

Why is Helixate NexGen approved?

The Agency decided that Helixate NexGen’s benefits are greater than its risks and recommended that it be given marketing authorisation. The Agency concluded that Helixate NexGen has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.

What measures are being taken to ensure the safe and effective use of Helixate NexGen?

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

Other information about Helixate NexGen

The European Commission granted a marketing authorisation valid throughout the EU for Helixate NexGen on 4 August 2000.

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

Name Language First published Last updated
Helixate NexGen : EPAR - Summary for the public BG = bălgarski 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public ES = español 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public CS = čeština 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public DA = dansk 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public DE = Deutsch 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public ET = eesti keel 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public EL = elliniká 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public EN = English 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public FR = français 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public IT = italiano 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public LV = latviešu valoda 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public LT = lietuvių kalba 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public HU = magyar 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public MT = Malti 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public NL = Nederlands 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public PL = polski 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public PT = português 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public RO = română 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public SK = slovenčina 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public SL = slovenščina 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public FI = suomi 2009-05-12 2018-01-15
Helixate NexGen : EPAR - Summary for the public SV = svenska 2009-05-12 2018-01-15

This EPAR was last updated on 15/01/2018 .

Authorisation details

Product details

Product details for Helixate NexGen
NameHelixate NexGen
Agency product numberEMEA/H/C/000276
Active substance

octocog alfa

International non-proprietary name (INN) or common name

octocog alfa

Therapeutic area Hemophilia A
Anatomical therapeutic chemical (ATC) code B02BD02

Publication details

Publication details for Helixate NexGen
Marketing-authorisation holder

Bayer AG


 

Revision31
Date of issue of marketing authorisation valid throughout the European Union04/08/2000

Contact address:

Bayer AG
51368 Leverkusen
Germany

Product information

Product information

16/11/2017  Helixate NexGen -EMEA/H/C/000276 -A31/0178

Name Language First published Last updated
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15
Helixate NexGen : EPAR - Product information SV = svenska 2009-11-12 2018-01-15

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.


Name Language First published Last updated
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16
Helixate NexGen : EPAR - All authorised presentations SV = svenska 2008-01-20 2015-12-16

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Helixate NexGen : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-11-12 2018-01-29
Helixate NexGen-H-C-0276-A31-0178 : EPAR - Assessment Report - Article 31 SV = svenska 2017-12-05  
Helixate NexGen-H-C-276-A20-143 : EPAR - Assessment Report - Article 20 SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation SV = svenska 2014-03-20  
Helixate NexGen-H-C-276-WS-193 : EPAR - Assessment Report - Variation SV = svenska 2012-05-21  
Helixate NexGen : EPAR - Steps taken after authorisation when a cutoff date has been used SV = svenska 2006-11-05  

Initial marketing-authorisation documents

Name Language First published Last updated
Helixate NexGen : EPAR - Procedural steps taken before authorisation SV = svenska 2006-11-05  
Helixate NexGen : EPAR - Scientific Discussion SV = svenska 2006-11-05  

Authorised

This medicine is approved for use in the European Union

News

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