BeneFIX

nonacog alfa

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This is a summary of the European Public Assessment Report (EPAR) for BeneFIX. 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 BeneFIX.

What is BeneFIX?

BeneFIX is a medicine that contains the active substance nonacog alfa. It is available as a powder and solvent that are mixed together to form a solution for injection.

What is BeneFIX used for?

BeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder). BeneFIX is intended for either short-term or long-term use.

The medicine can only be obtained with a prescription.

How is BeneFIX used?

BeneFIX should be started by a doctor who has experience in the treatment of haemophilia. During treatment, the doctor should regularly carry out blood tests to adjust the dose to be given.

BeneFIX is given by a slow injection into a vein, usually at up to 4 ml per minute and should not be mixed with other infusion solutions or given using a kit other than the one supplied with the medicine. The dose and the frequency of injection depend on whether BeneFIX is used to treat or prevent bleeding, or to reduce bleeding during surgery, and on the patient’s condition. The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery. Full details on how to calculate the dose are included in the summary of product characteristics.

Patients or their carers can give injections of BeneFIX, provided that they have been trained appropriately.

How does BeneFIX work?

The active substance in BeneFIX, nonacog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot). Patients with haemophilia B lack a protein called factor IX, which is involved in blood clotting. The lack of factor IX causes blood-clotting problems, such as bleeding in the joints, muscles and internal organs. BeneFIX is used to replace the missing factor IX. It corrects the factor IX deficiency and gives temporary control of the bleeding disorder.

Nonacog alfa is not extracted from human blood but produced by a method known as ‘recombinant DNA technology’: it is made by cells that have received a gene (DNA), which makes them able to produce human coagulation factor IX.

How has BeneFIX been studied?

BeneFIX has been studied in previously treated patients with moderate or severe haemophilia B for prevention or to treat bleeding episodes during and after surgery. It has also been studied in patients who have not received any treatment for their haemophilia. The studies assessed the number of bleeding episodes that occurred and rated BeneFIX’s effectiveness using a scale from ‘no response’ to ‘excellent’.

What benefit has BeneFIX shown during the studies?

In previously treated patients, 82% of the 693 bleeding episodes treated resolved after a single infusion of BeneFIX. Out of 972 infusions, 84% were rated as bringing about ‘good’ or ‘excellent’ responses.

What is the risk associated with BeneFIX?

Hypersensitivity (allergic) reactions have been seen in patients treated with products containing factor IX and may sometimes be severe. They include angioedema (swelling of the face and limbs), burning and stinging at the injection site, chills, flushing, urticaria (itchy rash), headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (fast heartbeat), tightness of the chest, tingling, vomiting and wheezing. Patients with haemophilia B may also develop neutralising antibodies (inhibitors) to factor IX. If antibodies develop, BeneFIX will not work effectively, which may result in a loss of bleeding control. For the full list of all side effects reported with BeneFIX, see the package leaflet.

BeneFIX must not be used in people who are hypersensitive (allergic) to recombinant coagulation factor IX, to any of the other ingredients, or to hamster proteins.

Why has BeneFIX been approved?

The CHMP decided that BeneFIX’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

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

Other information about BeneFIX

The European Commission granted a marketing authorisation valid throughout the European Union for BeneFIX on 27 August 1997.

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

Name Language First published Last updated
BeneFIX : EPAR - Summary for the public BG = bălgarski 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public ES = español 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public CS = čeština 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public DA = dansk 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public DE = Deutsch 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public ET = eesti keel 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public EL = elliniká 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public EN = English 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public FR = français 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public IT = italiano 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public LV = latviešu valoda 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public LT = lietuvių kalba 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public HU = magyar 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public MT = Malti 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public NL = Nederlands 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public PL = polski 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public PT = português 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public RO = română 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public SK = slovenčina 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public SL = slovenščina 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public FI = suomi 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public SV = svenska 2009-05-12 2015-10-30
BeneFIX : EPAR - Summary for the public HR = Hrvatski 2009-05-12 2015-10-30

This EPAR was last updated on 19/07/2016 .

Authorisation details

Product details

Product details for BeneFIX
NameBeneFIX
Agency product numberEMEA/H/C/000139
Active substance

nonacog alfa

International non-proprietary name (INN) or common name

nonacog alfa

Therapeutic area Hemophilia B
Anatomical therapeutic chemical (ATC) code B02BD09

Publication details

Publication details for BeneFIX
Marketing-authorisation holder

Pfizer Ltd
 

Revision33
Date of issue of marketing authorisation valid throughout the European Union27/08/1997

Contact address:

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

13/06/2016  BeneFIX -EMEA/H/C/000139 -IB/0137/G

Name Language First published Last updated
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19
BeneFIX : EPAR - Product Information HR = Hrvatski 2009-11-26 2016-07-19

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
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04
BeneFIX : EPAR - All Authorised presentations HR = Hrvatski 2008-06-06 2012-10-04

Pharmacotherapeutic group

Antihaemorrhagics

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
BeneFIX : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-12-06  
BeneFIX : EPAR - Scientific Discussion HR = Hrvatski 2005-12-06  

Authorised

This medicine is approved for use in the European Union

More information on BeneFIX