Rixubis

nonacog gamma

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

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

What is Rixubis and what is it used for?

Rixubis is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of factor IX. It can be used in patients of all ages, and for short-term or long-term use. Rixubis contains the active substance nonacog gamma.

How is Rixubis used?

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

Rixubis 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 Rixubis is used to treat or prevent bleeding, as well as the seriousness of the haemophilia, the extent and location of the bleeding and the patient’s age and health. For further information, see the summary of product characteristics (also part of the EPAR).

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

How does Rixubis work?

Patients with haemophilia B lack factor IX, which is needed for blood to clot properly. This lack causes blood clotting problems, such as bleeding in the joints, muscles or internal organs. The active substance in Rixubis, nonacog gamma, is a version of human factor IX and helps the blood to clot in the same way. Rixubis can therefore be used to replace the missing factor IX, giving temporary control of the bleeding disorder.

Nonacog gamma is not extracted from human blood but is made by a method known as ‘recombinant DNA technology’: it is made by hamster cells into which a gene (DNA) has been introduced that makes the cells able to produce the human clotting factor.

What benefits of Rixubis have been shown in studies?

The benefits of Rixubis in treating and preventing bleeding episodes have been shown in three main studies involving patients with severe or moderately severe haemophilia B. None of the studies compared the effectiveness of Rixubis directly with another medicine. Effectiveness in stopping bleeding was measured on a standard scale in which ‘excellent’ meant complete relief of pain and no signs of bleeding after a single dose of the medicine, and ‘good’ meant relief of pain and signs of improvement with a single dose, although further doses might be needed for complete resolution.

In the first study, involving 73 patients aged 12 to 59 years, 249 bleeding episodes were treated with Rixubis. The effect of treatment in stopping bleeding episodes was rated excellent in 41% of cases and good in a further 55%. With respect to prevention of bleeding, the average bleeding rate during treatment was 4.26 bleeds a year, compared with an average of about 17 per year before enrolment. A second study involved 23 children aged from just under 2 to nearly 12 years of age, who experienced 26 bleeding episodes during the study: treatment of bleeding episodes was rated as excellent in 50% of cases and good in another 46%, and the average bleeding rate was reduced from 6.8 to 2.7 bleeds per year. In a third study, Rixubis was given to 14 patients undergoing surgery; treatment with Rixubis kept blood loss during the surgery to levels expected in patients without haemophilia B.

The evaluation of these studies also indicated that Rixubis was distributed in the body similarly to another approved factor IX product.

What are the risks associated with Rixubis?

The most common side effects with Rixubis (which may affect up to 1 in 10 people) are dysgeusia (taste disturbances) and pain in the limbs. Hypersensitivity (allergic) reactions may occur rarely, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. For the full list of all side effects with Rixubis see the package leaflet.

Rixubis must not be used in patients who are hypersensitive (allergic) to nonacog gamma or any of its other ingredients, or who are known to be allergic to hamster protein.

Why is Rixubis approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Rixubis’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that Rixubis had been shown to be effective in preventing and treating bleeding episodes in adults and children with haemophilia B, and was also effective in allowing them to undergo surgery safely. The safety profile was considered acceptable and was outweighed by the beneficial effects.

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

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

Further information can be found in the summary of the risk management plan.

Other information about Rixubis

The European Commission granted a marketing authorisation valid throughout the European Union for Rixubis on 19 December 2014.

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

Name Language First published Last updated
Rixubis : EPAR - Summary for the public BG = bălgarski 2015-02-10  
Rixubis : EPAR - Summary for the public ES = español 2015-02-10  
Rixubis : EPAR - Summary for the public CS = čeština 2015-02-10  
Rixubis : EPAR - Summary for the public DA = dansk 2015-02-10  
Rixubis : EPAR - Summary for the public DE = Deutsch 2015-02-10  
Rixubis : EPAR - Summary for the public ET = eesti keel 2015-02-10  
Rixubis : EPAR - Summary for the public EL = elliniká 2015-02-10  
Rixubis : EPAR - Summary for the public EN = English 2015-02-10  
Rixubis : EPAR - Summary for the public FR = français 2015-02-10  
Rixubis : EPAR - Summary for the public IT = italiano 2015-02-10  
Rixubis : EPAR - Summary for the public LV = latviešu valoda 2015-02-10  
Rixubis : EPAR - Summary for the public LT = lietuvių kalba 2015-02-10  
Rixubis : EPAR - Summary for the public HU = magyar 2015-02-10  
Rixubis : EPAR - Summary for the public MT = Malti 2015-02-10  
Rixubis : EPAR - Summary for the public NL = Nederlands 2015-02-10  
Rixubis : EPAR - Summary for the public PL = polski 2015-02-10  
Rixubis : EPAR - Summary for the public PT = português 2015-02-10  
Rixubis : EPAR - Summary for the public RO = română 2015-02-10  
Rixubis : EPAR - Summary for the public SK = slovenčina 2015-02-10  
Rixubis : EPAR - Summary for the public SL = slovenščina 2015-02-10  
Rixubis : EPAR - Summary for the public FI = suomi 2015-02-10  
Rixubis : EPAR - Summary for the public SV = svenska 2015-02-10  
Rixubis : EPAR - Summary for the public HR = Hrvatski 2015-02-10  
Name Language First published Last updated
Rixubis : EPAR - Risk-management-plan summary (English only) 2015-02-10  

This EPAR was last updated on 18/04/2016 .

Authorisation details

Product details

Product details for Rixubis
NameRixubis
Agency product numberEMEA/H/C/003771
Active substance

nonacog gamma

International non-proprietary name (INN) or common name

nonacog gamma

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.

Publication details

Publication details for Rixubis
Marketing-authorisation holder

Baxalta Innovations GmbH

Revision4
Date of issue of marketing authorisation valid throughout the European Union19/12/2014

Contact address:

Baxalta Innovations GmbH
Industriestrasse 67 
1221 Vienna 
Austria

Product information

Product information

31/03/2016  Rixubis -EMEA/H/C/003771 -IB/0013/G

Name Language First published Last updated
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18
Rixubis : EPAR - Product Information EN = English 2015-02-10 2016-04-18

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
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  
Rixubis : EPAR - All Authorised presentations EN = English 2015-02-10  

Pharmacotherapeutic group

Antihaemorrhagics, blood coagulation factor IX

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
Rixubis : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-04-20 2016-04-18

Initial marketing-authorisation documents

Name Language First published Last updated
Rixubis : EPAR - Public assessment report EN = English 2015-02-10  
CHMP summary of positive opinion for Rixubis EN = English 2014-10-24  

Authorised

This medicine is approved for use in the European Union