Table of contents
Exjade is a medicine used to treat chronic iron overload (an excess of iron in the body) in:
- patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin in the blood) and who receive frequent blood transfusions;
- children aged 2 to 5 years with beta thalassaemia major who receive frequent blood transfusions, when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate;
- patients from 2 years of age with beta thalassaemia major who receive infrequent blood transfusions, when deferoxamine cannot be used or is inadequate;
- patients from 2 years of age who suffer from other types of anaemia (low levels of haemoglobin in the blood) and who receive blood transfusions, when deferoxamine cannot be used or is inadequate;
- patients from 10 years of age with non-transfusion-dependent thalassaemia syndromes, when deferoxamine cannot be used or is inadequate. Non-transfusion-dependent thalassaemia syndromes are blood disorders similar to beta thalassaemia major but which do not require blood transfusions. In these patients iron overload is caused by excess absorption of iron from the gut.
Exjade contains the active substance deferasirox.
Exjade : EPAR - Medicine overview (PDF/87.56 KB)
First published: 04/09/2008
Last updated: 13/08/2018
Exjade : EPAR - Risk-management-plan summary (PDF/1.01 MB)
First published: 25/07/2019
Last updated: 22/12/2022
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This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
Novartis Europharm Limited
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25/08/2022 Exjade - EMEA/H/C/000670 - II/0082/G
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older.
Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:
- in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) aged two to five years;
- in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (< 7 ml/kg/month of packed red blood cells) aged two years and older;
- in patients with other anaemias aged two years and older.
Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.