Xagrid

anagrelide

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

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

What is Xagrid and what is it used for?

Xagrid is a medicine 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.

Xagrid contains the active substance anagrelide.

How is Xagrid used?

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

Xagrid is available as capsules (0.5 mg). The recommended starting dose is 1 capsule twice a day. After a week, the dose is increased every week by 1 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 2 or 3 weeks of starting treatment.

The maximum recommended dose of Xagrid is 5 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 to improve symptoms in patients with the disease.

What benefits of Xagrid have been shown in studies?

Xagrid was effective in lowering platelet counts 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, defined as a platelet count of more than 600 million/ml. Most patients 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.

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. In the other three studies, the percentage of patients with a complete response ranged from 60% to 82%.

What are the risks 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 must not be used in patients with moderate or severe liver or kidney disease. For the full list of restrictions, see the package leaflet.

Why has Xagrid been approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Xagrid’s benefits are greater than its risks and recommended that it 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?

Since Xagrid has been approved under exceptional circumstances, the company that markets Xagrid will regularly 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 for Xagrid on 16 November 2004.

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

Name Language First published Last updated
Xagrid : EPAR - Summary for the public BG = bălgarski 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public ES = español 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public CS = čeština 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public DA = dansk 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public DE = Deutsch 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public ET = eesti keel 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public EL = elliniká 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public EN = English 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public FR = français 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public IT = italiano 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public LV = latviešu valoda 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public LT = lietuvių kalba 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public HU = magyar 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public MT = Malti 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public NL = Nederlands 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public PL = polski 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public PT = português 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public RO = română 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public SK = slovenčina 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public SL = slovenščina 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public FI = suomi 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public SV = svenska 2009-11-19 2017-03-01
Xagrid : EPAR - Summary for the public HR = Hrvatski 2009-11-19 2017-03-01

This EPAR was last updated on 18/07/2017 .

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.

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

Revision30
Date of issue of marketing authorisation valid throughout the European Union16/11/2004

Contact address:

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

Product information

Product information

16/06/2017  Xagrid -EMEA/H/C/000480 -PSUSA/208/201609

Name Language First published Last updated
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18
Xagrid : EPAR - Product Information HR = Hrvatski 2009-11-19 2017-07-18

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
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  
Xagrid : EPAR - All Authorised presentations HR = Hrvatski 2007-04-24  

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

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union

More information on Xagrid

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 29 December 2000. Xagrid was withdrawn from the Community register of orphan medicinal products in November 2016 at the end of the 12-year period of market exclusivity.