Xagrid

anagrelide

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Xagrid?

Xagrid is a medicine that contains the active substance anagrelide. It is available as white capsules (0.5 mg).

What is Xagrid used for?

Xagrid is used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets circulating in the blood). ‘Essential’ means that the disease has no obvious cause. Xagrid is used when patients do not respond to or do not tolerate their current treatment, and when they are ‘at risk’ because of their age (over 60 years), very high platelet counts or previous clotting problems.

Because the number of people with essential thrombocythaemia is low, the disease is considered ‘rare’, and Xagrid was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 29 December 2000.

The medicine can only be obtained with a prescription.

How is Xagrid used?

Treatment with Xagrid should only be started by a doctor who has experience in the treatment of essential thrombocythaemia.

The recommended starting dose of Xagrid is one capsule twice a day. After a week, the dose is increased every week by one capsule a day, until the patient achieves a platelet count below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the level usually seen in healthy people). Results are normally seen within two or three weeks of starting treatment.

The maximum recommended dose of Xagrid is five capsules at a time. Doses of up to 20 capsules a day were used during the development and testing of the medicine.

How does Xagrid work?

Essential thrombocythaemia is a disease in which the bone marrow produces too many platelets. This puts the patient at risk of developing blood clots or bleeding problems. The active substance in Xagrid, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes’, which produce platelets. This reduces the platelet count, helping patients with the disease.

How has Xagrid been studied?

Xagrid has been studied in four main studies involving patients with various diseases in which the bone marrow produces too many cells. Almost 3,000 of the patients in the studies had essential thrombocythaemia, most of whom had previously received other medicines but needed to change treatment. Xagrid was not compared with any other medicines. Patients were treated with Xagrid for up to five years. The main measure of effectiveness was the number of patients who had a ‘complete response’, defined as a reduction in platelet counts of at least 50% from the start of treatment or to below 600 million/ml.

What benefit has Xagrid shown during the studies?

Xagrid was effective in lowering platelet counts. In the largest study, 67% of the patients with essential thrombocythaemia (628 out of 934), and 66% of those who could not tolerate or did not respond to other treatments (480 out of 725) had a complete response to Xagrid. The number of clotting and bleeding problems experienced by the patients fell during the studies, but the benefit of this was not shown convincingly.

What is the risk associated with Xagrid?

The most common side effect with Xagrid (seen in more than 1 patient in 10) is headache. For the full list of all side effects reported with Xagrid, see the package leaflet.

Xagrid should not be used in people who may be hypersensitive (allergic) to anagrelide or any of the other ingredients. Xagrid must not be used in patients with moderate or severe liver or kidney disease.

Why has Xagrid been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Xagrid had shown its effectiveness in lowering platelet counts in patients with essential thrombocythaemia. The Committee decided that Xagrid’s benefits are greater than its risks as second-line treatment in at-risk patients with essential thrombocythaemia. The Committee recommended that Xagrid be given marketing authorisation.

Xagrid has been authorised under ‘exceptional circumstances’. This means that, because the disease is rare, it has not been possible to obtain complete information about Xagrid. 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 Xagrid?

The company that markets Xagrid will carry out further studies, looking in particular at comparing Xagrid with hydroxyurea (another medicine used in essential thrombocythaemia) and at the use of Xagrid in pregnancy. It will also inform the CHMP of all information published on the effectiveness of the medicine.

Other information about Xagrid

The European Commission granted a marketing authorisation valid throughout the European Union to Shire Pharmaceutical Contracts Limited for Xagrid on 16 November 2004. The marketing authorisation was renewed on 16 November 2009.

Name Language First published Last updated
Xagrid : EPAR - Summary for the public BG = bălgarski 19/11/2009  
Xagrid : EPAR - Summary for the public ES = español 19/11/2009  
Xagrid : EPAR - Summary for the public CS = čeština 19/11/2009  
Xagrid : EPAR - Summary for the public DA = dansk 19/11/2009  
Xagrid : EPAR - Summary for the public DE = Deutsch 19/11/2009  
Xagrid : EPAR - Summary for the public ET = eesti keel 19/11/2009  
Xagrid : EPAR - Summary for the public EL = elliniká 19/11/2009  
Xagrid : EPAR - Summary for the public EN = English 19/11/2009  
Xagrid : EPAR - Summary for the public FR = français 19/11/2009  
Xagrid : EPAR - Summary for the public IT = italiano 19/11/2009  
Xagrid : EPAR - Summary for the public LV = latviešu valoda 19/11/2009  
Xagrid : EPAR - Summary for the public LT = lietuvių kalba 19/11/2009  
Xagrid : EPAR - Summary for the public HU = magyar 19/11/2009  
Xagrid : EPAR - Summary for the public MT = Malti 19/11/2009  
Xagrid : EPAR - Summary for the public NL = Nederlands 19/11/2009  
Xagrid : EPAR - Summary for the public PL = polski 19/11/2009  
Xagrid : EPAR - Summary for the public PT = português 19/11/2009  
Xagrid : EPAR - Summary for the public RO = română 19/11/2009  
Xagrid : EPAR - Summary for the public SK = slovenčina 19/11/2009  
Xagrid : EPAR - Summary for the public SL = slovenščina 19/11/2009  
Xagrid : EPAR - Summary for the public FI = suomi 19/11/2009  
Xagrid : EPAR - Summary for the public SV = svenska 19/11/2009  

This EPAR was last updated on 18/02/2014 .

Authorisation details

Product details

Product details for Xagrid
NameXagrid
Agency product numberEMEA/H/C/000480
Active substance

anagrelide

International non-proprietary name (INN) or common name

anagrelide

Therapeutic area Thrombocythemia, Essential
Anatomical therapeutic chemical (ATC) code L01XX35
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.

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 Xagrid
Marketing-authorisation holder

Shire Pharmaceutical Contracts Limited

Revision21
Date of issue of marketing authorisation valid throughout the European Union16/11/2004

Contact address:

Shire Pharmaceutical Contracts Ltd.
Hampshire International Business Park
Chineham
Basingstoke
Hants
RG24 8EP
United Kingdom

Product information

Product information

30/01/2014  Xagrid -EMEA/H/C/000480 -IA/0058/G

Name Language First published Last updated
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014
Xagrid : EPAR - Product Information SV = svenska 19/11/2009 18/02/2014

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
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  
Xagrid : EPAR - All Authorised presentations SV = svenska 24/04/2007  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Xagrid is indicated for the reduction of elevated platelet counts in at-risk essential-thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.

An at-risk patient

An at-risk ET is defined by one or more of the following features:

  • >60 years of age or;
  • a platelet count >1000 x 109/l or;
  • a history of thrombohaemorrhagic events.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Xagrid : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 19/11/2009 18/02/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Xagrid : EPAR - Procedural steps taken before authorisation SV = svenska 24/04/2007  
Xagrid : EPAR - Scientific Discussion SV = svenska 24/04/2007  

Authorised

This medicine is approved for use in the European Union