Adynovi

rurioctocog alfa pegol

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

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

What is Adynovi and what is it used for?

Adynovi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII. It can be used in adults and children from 12 years of age.

Adynovi contains the active substance rurioctocog alfa pegol.

How is Adynovi used?

Adynovi 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.

Adynovi 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 whether it is used to treat or prevent bleeding, as well as on the seriousness of the haemophilia, the extent and location of the bleeding and the patient’s condition and bodyweight. Patients or their carers may be able to inject Adynovi themselves at home once they have been trained appropriately.

For further details, see the package leaflet.

How does Adynovi work?

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

What benefits of Adynovi have been shown in studies?

Adynovi has been shown in two main studies to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.

In a study involving 138 adults and adolescents aged 12 years or above, 120 patients given Adynovi as a twice-weekly preventive treatment had, on average, around 4 bleeding episodes a year, and 17 patients given Adynovi for treating bleedings ‘on demand’ had around 43 bleeding episodes a year. In addition, when bleeding did occur, Adynovi was rated excellent or good at treating around 96% of bleeding episodes. Around 96% of bleeding episodes resolved with one or two injections of Adynovi.

In the second study in 66 children aged below 12 years, all patients were given Adynovi as a twice-weekly preventive treatment for around 6 months. During this period, around 38% of patients (25 out of 66) had no bleeding episodes, and none of the patients developed antibodies against Adynovi, which can cause the medicine to stop working. When bleeding occurred, Adynovi was rated excellent or good at treating around 90% of episodes. Around 83% of bleeding episodes resolved with one injection.

What are the risks associated with Adynovi?

Hypersensitivity (allergic) reactions are uncommon with Adynovi (affecting up to 1 in 100 people) and may include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing. In some cases these reactions can become severe.

Following treatment with factor VIII products, including Adynovi, some patients may 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 see the package leaflet.

Adynovi must not be used in patients who are hypersensitive (allergic) to rurioctocog alfa pegol or the related substance octocog alfa or to any of the other ingredients of the medicine, nor in those with known allergy to mouse or hamster proteins.

Why is Adynovi approved?

The European Medicines Agency decided that Adynovi’s benefits are greater than its risks and recommended that it be approved for use in the EU. Studies show that Adynovi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products. However, part of the active substance in Adynovi (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment. Since this could potentially cause problems especially in children below 12 years of age, Adynovi is only approved for use in adults and children from 12 years of age.

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

The company that markets Adynovi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.

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

Other information about Adynovi

The European Commission granted a marketing authorisation valid throughout the European Union for Adynovi on 8 January 2018.

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

Name Language First published Last updated
Adynovi : EPAR - Summary for the public BG = bălgarski 2018-02-16  
Adynovi : EPAR - Summary for the public ES = español 2018-02-16  
Adynovi : EPAR - Summary for the public CS = čeština 2018-02-16  
Adynovi : EPAR - Summary for the public DA = dansk 2018-02-16  
Adynovi : EPAR - Summary for the public DE = Deutsch 2018-02-16  
Adynovi : EPAR - Summary for the public ET = eesti keel 2018-02-16  
Adynovi : EPAR - Summary for the public EL = elliniká 2018-02-16  
Adynovi : EPAR - Summary for the public EN = English 2018-02-16  
Adynovi : EPAR - Summary for the public FR = français 2018-02-16  
Adynovi : EPAR - Summary for the public IT = italiano 2018-02-16  
Adynovi : EPAR - Summary for the public LV = latviešu valoda 2018-02-16  
Adynovi : EPAR - Summary for the public LT = lietuvių kalba 2018-02-16  
Adynovi : EPAR - Summary for the public HU = magyar 2018-02-16  
Adynovi : EPAR - Summary for the public MT = Malti 2018-02-16  
Adynovi : EPAR - Summary for the public NL = Nederlands 2018-02-16  
Adynovi : EPAR - Summary for the public PL = polski 2018-02-16  
Adynovi : EPAR - Summary for the public PT = português 2018-02-16  
Adynovi : EPAR - Summary for the public RO = română 2018-02-16  
Adynovi : EPAR - Summary for the public SK = slovenčina 2018-02-16  
Adynovi : EPAR - Summary for the public SL = slovenščina 2018-02-16  
Adynovi : EPAR - Summary for the public FI = suomi 2018-02-16  
Adynovi : EPAR - Summary for the public SV = svenska 2018-02-16  
Adynovi : EPAR - Summary for the public HR = Hrvatski 2018-02-16  

This EPAR was last updated on 09/04/2018 .

Authorisation details

Product details

Product details for Adynovi
NameAdynovi
Agency product numberEMEA/H/C/004195
Active substance

rurioctocog alfa pegol

International non-proprietary name (INN) or common name

rurioctocog alfa pegol

Therapeutic area Hemophilia A
Anatomical therapeutic chemical (ATC) code B02BD02
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 Adynovi
Marketing-authorisation holder

Baxalta Innovations GmbH

Revision1
Date of issue of marketing authorisation valid throughout the European Union08/01/2018

Contact address:

Baxalta Innovations GmbH
Industriestrasse 67 
A-1221 Vienna 
Austria

Product information

Product information

12/03/2018  Adynovi -EMEA/H/C/004195 -IB/0001

Name Language First published Last updated
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09
Adynovi : EPAR - Product Information HR = Hrvatski 2018-02-16 2018-04-09

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
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  
Adynovi : EPAR - All Authorised presentations HR = Hrvatski 2018-02-16  

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Adynovi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2018-04-09  

Initial marketing-authorisation documents

Name Language First published Last updated
Adynovi : EPAR - Public assessment report HR = Hrvatski 2018-02-16  
CHMP summary of positive opinion for Adynovi HR = Hrvatski 2017-11-10  

Authorised

This medicine is approved for use in the European Union