Idelvion

albutrepenonacog alfa

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This is a summary of the European public assessment report (EPAR) for Idelvion. 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 Idelvion.

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

What is Idelvion and what is it used for?

Idelvion is a medicine used to prevent and treat bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX. It can be used in patients of all ages.

Because the number of patients with haemophilia B is low, the disease is considered ‘rare’, and Idelvion was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 4 February 2010.

Idelvion contains the active substance albutrepenonacog alfa.

How is Idelvion used?

Idelvion can only be obtained with a prescription, and treatment should be supervised by a doctor with experience in treating haemophilia.

Idelvion is available as powder and solvent that are mixed together to make a solution for injection into a vein. The dose and the frequency of the injections depend on the patient’s bodyweight and whether Idelvion is used to treat or prevent bleeding, as well as the severity of the patient’s factor IX deficiency, the extent and location of the bleeding and the patient’s age and health. For further information on how to use this medicine, see the summary of product characteristics (also part of the EPAR).

How does Idelvion work?

Patients with haemophilia B lack factor IX, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Idelvion, albutrepenonacog alfa, works in the body in the same way as human factor IX. It replaces the missing factor IX, thereby helping the blood to clot and giving temporary control of bleeding.

What benefits of Idelvion have been shown in studies?

In a study in 80 adults and adolescents and another study in 27 children aged less than 12 years, Idelvion was effective at preventing bleeding, with most patients experiencing no bleeding while on preventive treatment. Furthermore, Idelvion was effective in treating bleeding episodes when they did occur; around 93% of the bleeding episodes resolved with one Idelvion injection.

What are the risks associated with Idelvion?

Hypersensitivity (allergic) reactions can occur rarely with Idelvion and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing. In some cases these reactions can become severe.

Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control. Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels. For the full list of side effects reported with Idelvion, see the package leaflet.

Idelvion must not be used in patients who are hypersensitive (allergic) to the active substance or other ingredients of the medicine. It must also not be used in patients allergic to hamster proteins.

Why is Idelvion approved?

Studies show that Idelvion is effective at preventing and treating bleeding episodes in patients with haemophilia B, and its safety is comparable to that of other factor IX products. The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Idelvion’s benefits are greater than its risks and recommended that it be approved for use in the EU.

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

A risk management plan has been developed to ensure that Idelvion is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Idelvion, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Idelvion

The European Commission granted a marketing authorisation valid throughout the European Union for Idelvion on 11 May 2016.

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

Name Language First published Last updated
Idelvion : EPAR - Summary for the public BG = bălgarski 2016-05-27  
Idelvion : EPAR - Summary for the public ES = español 2016-05-27  
Idelvion : EPAR - Summary for the public CS = čeština 2016-05-27  
Idelvion : EPAR - Summary for the public DA = dansk 2016-05-27  
Idelvion : EPAR - Summary for the public DE = Deutsch 2016-05-27  
Idelvion : EPAR - Summary for the public ET = eesti keel 2016-05-27  
Idelvion : EPAR - Summary for the public EL = elliniká 2016-05-27  
Idelvion : EPAR - Summary for the public EN = English 2016-05-27  
Idelvion : EPAR - Summary for the public FR = français 2016-05-27  
Idelvion : EPAR - Summary for the public IT = italiano 2016-05-27  
Idelvion : EPAR - Summary for the public LV = latviešu valoda 2016-05-27  
Idelvion : EPAR - Summary for the public LT = lietuvių kalba 2016-05-27  
Idelvion : EPAR - Summary for the public HU = magyar 2016-05-27  
Idelvion : EPAR - Summary for the public MT = Malti 2016-05-27  
Idelvion : EPAR - Summary for the public NL = Nederlands 2016-05-27  
Idelvion : EPAR - Summary for the public PL = polski 2016-05-27  
Idelvion : EPAR - Summary for the public PT = português 2016-05-27  
Idelvion : EPAR - Summary for the public RO = română 2016-05-27  
Idelvion : EPAR - Summary for the public SK = slovenčina 2016-05-27  
Idelvion : EPAR - Summary for the public SL = slovenščina 2016-05-27  
Idelvion : EPAR - Summary for the public FI = suomi 2016-05-27  
Idelvion : EPAR - Summary for the public SV = svenska 2016-05-27  
Idelvion : EPAR - Summary for the public HR = Hrvatski 2016-05-27  

This EPAR was last updated on 17/11/2016 .

Authorisation details

Product details

Product details for Idelvion
NameIdelvion
Agency product numberEMEA/H/C/003955
Active substance

albutrepenonacog alfa

International non-proprietary name (INN) or common name

albutrepenonacog alfa

Therapeutic area Hemophilia B
Anatomical therapeutic chemical (ATC) code B02BD04
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Idelvion
Marketing-authorisation holder

CSL Behring GmbH

Revision1
Date of issue of marketing authorisation valid throughout the European Union11/05/2016

Contact address:

CSL Behring GmbH
Emil-von-Behring-Straße 76 
35041 Marburg 
Germany

Product information

Product information

28/09/2016  Idelvion -EMEA/H/C/003955 -N/0002

Name Language First published Last updated
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17
Idelvion : EPAR - Product Information HR = Hrvatski 2016-05-27 2016-11-17

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
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  
Idelvion : EPAR - All Authorised presentations HR = Hrvatski 2016-05-27  

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Idelvion : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-11-17  

Initial marketing-authorisation documents

Name Language First published Last updated
Idelvion : EPAR - Public assessment report HR = Hrvatski 2016-05-27  
CHMP summary of positive opinion for Idelvion HR = Hrvatski 2016-02-26  

Authorised

This medicine is approved for use in the European Union

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