ATryn

antithrombin alfa

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

What is ATryn?

ATryn is a powder that is made up into a solution for infusion (drip) into a vein. It contains the active substance antithrombin alfa.

What is ATryn used for?

ATryn is used in adults who have ‘congenital antithrombin deficiency’ (inherited low levels of the protein antithrombin). It is used when the patients are having surgery, to prevent problems due to the formation of blood clots. ATryn is normally given with heparin (another medicine that helps to prevent blood clots).

The medicine can only be obtained with a prescription.

How is ATryn used?

Treatment with ATryn should only be started by doctors who are experienced in treating patients with congenital antithrombin deficiency. The doctor needs to calculate the doses to use, based both on the patient’s weight and on the level of antithrombin activity.

The first infusion lasts 15 minutes. This is followed by a continuous infusion at a lower dose, during which the patients should be continually monitored and the infusion rate adjusted, so that the antithrombin activity is at least 80% of the normal level for the duration of treatment. See the package leaflet for full instructions.

How does ATryn work?

ATryn is an anticlotting agent. The active substance in ATryn, antithrombin alfa, is a copy of the natural blood protein antithrombin, which is produced by ‘recombinant DNA technology’: it is extracted from the milk of goats that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.

In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting. Patients who have congenital antithrombin deficiency have low blood antithrombin levels and are therefore at increased risk of having blood clots. ATryn corrects the antithrombin deficiency, and gives temporary control of the clotting disorder.

How has ATryn been studied?

One study of ATryn was carried out in 14 patients aged between 21 and 74 years who had congenital antithrombin deficiency and were at risk of blood clot formation either during surgery (five patients) or during childbirth (nine patients). The studies measured how many patients developed deep vein thrombosis (DVT, formation of a blood clot in a deep vein, usually in the leg) during the 30 days after treatment. Few patients were treated during the study because congenital antithrombin deficiency is rare - it is estimated that only about one person in 3,000 to 5,000 has the condition.

In addition, ATryn was used in five patients who received the medicine during surgery in a ‘compassionate-use programme’ (a programme through which doctors can request a medicine for one of their patients before it is authorised).

What benefit has ATryn shown during the studies?

In the study, among the 13 patients in whom the effectiveness of the treatment could be assessed, two had an episode of DVT, of which only one needed treatment. In the compassionate-use programme, no blood clots were seen in the patients receiving ATryn. Taken together, the results support the effectiveness of ATryn in preventing blood clot development in patients having surgery. However, there was not enough information to identify the most appropriate dose to use during childbirth.

What is the risk associated with ATryn?

In studies, the most common side effects with ATryn (seen in between 1 and 10 patients in 100) were dizziness, headache, haemorrhage (bleeding, including bleeding at the site of the injection or after surgery), nausea (feeling sick) and wound secretion (discharge from the surgical wound).

ATryn must not be used in people who may be hypersensitive (allergic) to goat proteins or goat milk. Because ATryn is a protein given by injection, patients could develop antibodies (proteins produced in response to the medicine), with a risk of an allergic reaction at the time of injection. However, this has not yet been seen in patients treated with ATryn. For the full list of side effects and restrictions with ATryn, see the package leaflet.

Why has ATryn been approved?

The CHMP concluded that the information provided by the company had shown that ATryn can bring the antithrombin activity up to an acceptable level when used at the recommended dose during surgery. The Committee decided that ATryn’s benefits are greater than its risks and recommended that it be given marketing authorisation.

ATryn has been authorised under ‘exceptional circumstances’. This means that because the disease is rare, it has not been possible to obtain complete information about ATryn. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for ATryn?

The company that makes ATryn has provided the results of a study looking at the use of ATryn during childbirth in women with congenital antithrombin deficiency to the Agency, and will submit an application with the aim of adding treatment during childbirth to the medicine’s marketing authorisation. The company will also put in place, before launch in any European Union (EU) Member State, programmes to ensure that doctors can report information on the patients they treat and monitor the development of antibodies against ATryn.

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

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

Other information about ATryn

The European Commission granted a marketing authorisation valid throughout the EU for ATryn on 28 July 2006.

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

Name Language First published Last updated
ATryn : EPAR - Summary for the public BG = bălgarski 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public ES = español 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public CS = čeština 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public DA = dansk 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public DE = Deutsch 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public ET = eesti keel 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public EL = elliniká 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public EN = English 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public FR = français 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public IT = italiano 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public LV = latviešu valoda 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public LT = lietuvių kalba 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public HU = magyar 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public MT = Malti 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public NL = Nederlands 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public PL = polski 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public PT = português 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public RO = română 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public SK = slovenčina 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public SL = slovenščina 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public FI = suomi 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public SV = svenska 25/08/2009 20/07/2016
ATryn : EPAR - Summary for the public HR = Hrvatski 25/08/2009 20/07/2016

This EPAR was last updated on 20/07/2016 .

Authorisation details

Product details

Product details for ATryn
NameATryn
Agency product numberEMEA/H/C/000587
Active substance

antithrombin alfa

International non-proprietary name (INN) or common name

antithrombin alfa

Therapeutic area Antithrombin III Deficiency
Anatomical therapeutic chemical (ATC) code B01AB02
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.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for ATryn
Marketing-authorisation holder

GTC Biotherapeutics UK Limited

Revision12
Date of issue of marketing authorisation valid throughout the European Union28/07/2006

Contact address:

GTC Biotherapeutics UK Limited
10 Norwich Street
London EC4A 1BD
United Kingdom

Product information

Product information

15/07/2016  ATryn -EMEA/H/C/000587 -R/0024

Name Language First published Last updated
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016
ATryn : EPAR - Product Information HR = Hrvatski 21/08/2009 20/07/2016

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
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016
ATryn : EPAR - All Authorised presentations HR = Hrvatski 11/01/2007 20/07/2016

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. ATryn is normally given in association with heparin or low molecular weight heparin.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
ATryn : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 21/08/2009 20/07/2016

Initial marketing-authorisation documents

Name Language First published Last updated
ATryn : EPAR - Procedural steps taken before authorisation HR = Hrvatski 11/01/2007  
ATryn : EPAR - Scientific Discussion HR = Hrvatski 11/01/2007  

Authorised

This medicine is approved for use in the European Union