Alprolix

eftrenonacog alfa

  • Email
  • Help

About

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

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

What is Alprolix and what is it used for?

Alprolix is a medicine used to treat and prevent 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 Alprolix was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 June 2007.

Alprolix contains the active substance eftrenonacog alfa.

How is Alprolix used?

Alprolix can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.

Alprolix is available as a powder and solvent that are mixed together to make a solution for injection into a vein. The dose and frequency of treatment depend on the patient’s bodyweight and whether Alprolix 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).

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

How does Alprolix 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 Alprolix, eftrenonacog 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 Alprolix have been shown in studies?

Alprolix has been shown to be effective at both preventing and treating bleeding episodes in 2 main studies in patients with haemophilia B.

In the first study involving 123 adults and adolescents aged 12 years or above, patients given Alprolix as a weekly preventive treatment had around 3 bleeding episodes a year, patients given Alprolix as an every 10 days preventive treatment had around 2 bleeding episodes per year, and patients given Alprolix for treating bleedings on demand had around 18 bleeding episodes a year. In addition, when bleeding did occur, around 90% of bleeding episodes resolved with one injection of Alprolix.

In the second study in 30 children aged below 12 years, Alprolix was similarly effective: 2 bleeding episodes occurred per year on average and around 75% of bleeding episodes resolved with one injection.

What are the risks associated with Alprolix?

Hypersensitivity (allergic) reactions are seen rarely with Alprolix 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 all side effects and restrictions with Alprolix, see the package leaflet.

Why is Alprolix approved?

Studies show that Alprolix 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 Alprolix’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 Alprolix?

A risk management plan has been developed to ensure that Alprolix 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 Alprolix, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Alprolix

The European Commission granted a marketing authorisation valid throughout the European Union for Alprolix on 12 May 2016.

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

Name Language First published Last updated
Alprolix : EPAR - Summary for the public BG = bălgarski 2016-05-25  
Alprolix : EPAR - Summary for the public ES = español 2016-05-25  
Alprolix : EPAR - Summary for the public CS = čeština 2016-05-25  
Alprolix : EPAR - Summary for the public DA = dansk 2016-05-25  
Alprolix : EPAR - Summary for the public DE = Deutsch 2016-05-25  
Alprolix : EPAR - Summary for the public ET = eesti keel 2016-05-25  
Alprolix : EPAR - Summary for the public EL = elliniká 2016-05-25  
Alprolix : EPAR - Summary for the public EN = English 2016-05-25  
Alprolix : EPAR - Summary for the public FR = français 2016-05-25  
Alprolix : EPAR - Summary for the public IT = italiano 2016-05-25  
Alprolix : EPAR - Summary for the public LV = latviešu valoda 2016-05-25  
Alprolix : EPAR - Summary for the public LT = lietuvių kalba 2016-05-25  
Alprolix : EPAR - Summary for the public HU = magyar 2016-05-25  
Alprolix : EPAR - Summary for the public MT = Malti 2016-05-25  
Alprolix : EPAR - Summary for the public NL = Nederlands 2016-05-25  
Alprolix : EPAR - Summary for the public PL = polski 2016-05-25  
Alprolix : EPAR - Summary for the public PT = português 2016-05-25  
Alprolix : EPAR - Summary for the public RO = română 2016-05-25  
Alprolix : EPAR - Summary for the public SK = slovenčina 2016-05-25  
Alprolix : EPAR - Summary for the public SL = slovenščina 2016-05-25  
Alprolix : EPAR - Summary for the public FI = suomi 2016-05-25  
Alprolix : EPAR - Summary for the public SV = svenska 2016-05-25  
Alprolix : EPAR - Summary for the public HR = Hrvatski 2016-05-25  

This EPAR was last updated on 24/11/2016 .

Authorisation details

Product details

Product details for Alprolix
NameAlprolix
Agency product numberEMEA/H/C/004142
Active substance

eftrenonacog alfa

International non-proprietary name (INN) or common name

eftrenonacog 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 Alprolix
Marketing-authorisation holder

Swedish Orphan Biovitrum AB (publ)

Revision1
Date of issue of marketing authorisation valid throughout the European Union12/05/2016

Contact address:

Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm
Sweden

Product information

Product information

26/10/2016  Alprolix -EMEA/H/C/004142 - T-0001

Name Language First published Last updated
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24
Alprolix : EPAR - Product Information HR = Hrvatski 2016-05-25 2016-11-24

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
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  
Alprolix : EPAR - All Authorised presentations HR = Hrvatski 2016-05-25  

Pharmacotherapeutic group

Vitamin k and other hemostatics, blood coagulation factors

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
Alprolix : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-11-24  

Initial marketing-authorisation documents

Name Language First published Last updated
Alprolix : EPAR - Public assessment report HR = Hrvatski 2016-05-25  
CHMP summary of opinion for Alprolix HR = Hrvatski 2016-02-26