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?
- Dynepo - Shire Pharmaceutical Contracts Limited
Prescription drugs listed. Manufacturer: "Shire Pharmaceutical Contracts Limited"
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.
The full EPAR for Xagrid can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Xagrid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in