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 6 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 2 to 5 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 2 years and older.
in patients with other anaemias aged 2 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 thalassemia syndromes aged 10 years and older.
This information is based on the European Summary of Product Characteristics. The prescribing information in your country may vary; please consult your local prescribing information and/or contact your local Novartis representative.
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Important Safety Information
Exjade may cause serious kidney problems, liver problems, and bleeding in the stomach or intestines. In some cases, these problems were fatal. Kidney problems occurred particularly in patients with multiple medical conditions and those who were very ill because of their disease. Bleeding in the stomach or intestines occurred more often in elderly patients. Liver problems were more likely to happen in elderly patients.
Exjade should not be taken by patients with pre-existing severe kidney and liver problems; high-risk myelodysplastic syndromes; advanced cancer; low platelet counts; or an allergy to Exjade.
Since Exjade has been on the market, there have been reports of serious reactions, sometimes leading to death. Severe blood disorders (including neutropenia, agranulocytosis, worsening anemia and thrombocytopenia), serious allergic reactions (including swelling of the throat), severe skin reactions (including Stevens Johnson syndrome , toxic epidermal necrolysis (TEN) and erythema multiforme), decreased hearing and vision changes have been reported. These serious reactions and deaths have happened most often when Exjade was taken by elderly patients. The most commonly reported side effects related to Exjade in clinical trials were nausea, vomiting, diarrhea, abdominal pain, increases in kidney laboratory values, and skin rash.