Advate

octocog alfa

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Advate. 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 Advate. For practical information about using Advate, patients should read the package leaflet or contact their doctor or pharmacist.

What is Advate and what is it used for?

Advate 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 Advate used?

Advate can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia and with resuscitation equipment available in case of severe allergic reaction (anaphylaxis).

Advate is available as a powder and solvent that are mixed together to make a solution for injection into a vein. The dose and duration of treatment depend on whether Advate 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. Advate is intended for either short-term or long-term use.

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

How does Advate work?

The active substance in Advate, 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 or internal organs. Advate 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 Advate have been shown in studies?

Advate is similar to another medicine approved in the EU called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine. Because of this Advate has been compared with Recombinate to show that the two medicines are equivalent in one main study including 111 patients with haemophilia A.

The study went on to look at the number of bleeding episodes and rated Advate’s effectiveness in stopping bleeding on a scale from ‘none’ to ‘excellent’ in 107 patients, all of whom received Advate. The effectiveness of Advate was rated as ‘excellent’ or ‘good’ in 86% of 510 new bleeding episodes. In addition, 81% of these bleeding episodes required only a single treatment with Advate.

Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of 6 years. The additional studies confirmed Advate’s effectiveness, including in children under 6 years of age.

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. Advate 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 were not considered sufficient to specifically approve the medicine for this use.

What are the risks associated with Advate?

Common side effects with Advate (affecting between 1 and 10 patients in 100) are headache and pyrexia (fever).

Hypersensitivity (allergic) reactions have been reported and may in some cases become severe.

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 Advate, see the package leaflet. Advate must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.

Why is Advate approved?

The Agency decided that Advate’s benefits are greater than its risks and recommended that it be given marketing authorisation. The Agency concluded that Advate 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 Advate?

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

Other information about Advate

The European Commission granted a marketing authorisation valid throughout the EU for Advate on 2 March 2004.

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

Name Language First published Last updated
Advate : EPAR - Summary for the public BG = bălgarski 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public ES = español 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public CS = čeština 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public DA = dansk 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public DE = Deutsch 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public ET = eesti keel 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public EL = elliniká 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public EN = English 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public FR = français 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public IT = italiano 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public LV = latviešu valoda 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public LT = lietuvių kalba 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public HU = magyar 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public MT = Malti 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public NL = Nederlands 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public PL = polski 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public PT = português 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public RO = română 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public SK = slovenčina 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public SL = slovenščina 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public FI = suomi 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public SV = svenska 2009-04-16 2018-01-15
Advate : EPAR - Summary for the public HR = Hrvatski 2009-04-16 2018-01-15

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

Authorisation details

Product details

Product details for Advate
NameAdvate
Agency product numberEMEA/H/C/000520
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 Advate
Marketing-authorisation holder

Baxter AG

Revision22
Date of issue of marketing authorisation valid throughout the European Union02/03/2004

Contact address:

Baxter AG
Industriestrasse 67
A-1221 Vienna
Austria

Product information

Product information

24/11/2017  Advate -EMEA/H/C/000520 -A31/0078

Name Language First published Last updated
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 2018-01-15
Advate : EPAR - Product Information HR = Hrvatski 2009-07-14 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
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28
Advate : EPAR - All Authorised presentations HR = Hrvatski 2008-07-04 2014-08-28

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).

Advate does not contain von Willebrand factor in pharmacologically effective quantities and is therefore not indicated in von Willebrand disease.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Advate : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-07-14 2018-01-29
Advate-H-C-0520-A31-0078 : EPAR - Assessment Report - Article 31 HR = Hrvatski 2017-12-05  

Initial marketing-authorisation documents

Name Language First published Last updated
Advate : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-04-03  
Advate : EPAR - Scientific Discussion HR = Hrvatski 2006-04-03