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Description of the preparation.

Exjade 250mg (deferazirox) – complexing remedy, is a tridentate ligand, which binds iron with high affinity in a ratio of 2 : 1. The remedy is used in the treatment of post transfusion (non-transfusion with thalassemia) chronic iron overload in patients aged 2 and 10 years, respectively. The using of Exjade 250mg showed the following ratios of excretion / intake of iron: 1.02 (normal iron balance) and 1.67 (elevated excretion of iron). The remedy was used in doses of 20 mg / kg and 30 mg / kg, while patients continued blood transfusion. A similar effect occurred when using the remedy in patients with iron overload, as well as in patients suffering from other types of anemia.

Method of application, dosage.

In chronic post-transfusion overload with iron, the using of Exjade 250mg is permissible after transfusion of more than 20 units of erythrocyte mass (approximately 100 ml / kg) or with available data that indicate the patient’s development of chronic iron overload.

Exjade 250mg is taken orally once a day on an empty stomach. Admission should be at least 30 minutes before meals at the same time.
The recommended initial dose is 20 mg / kg body weight.
Patients who receive more than 4 blood transfusions per month (14 ml / kg / month) may receive a dose of 30 mg / kg body weight.
Patients who receive more than two blood transfusions per month (7 ml / kg / month) may receive a dose of 10 mg / kg body weight.
If the patient has a good clinical response to deferoxamine treatment, half of the previous prescribed dose of deferoxamine should be given (in patients who took 40 mg / kg / day of Exjade, treatment with the remedy starts with 20 mg / kg / day).
During treatment with Exjade 250mg it is necessary to control the concentration of ferritin in the blood, based on the changes in this indicator, it is necessary to correct the dose every 3 – 6 months. The direction of dose modification depends on the individual effectiveness of treatment and therapeutic tasks (maintenance or reduction of the amount of iron).
In chronic nontransfusion overload with iron, chelating therapy can be prescribed exclusively with proven iron overload. If patients have not evaluated the iron content in the liver, chelating therapy should be used with caution in order to reduce the risk of excessive chelating.

The recommended initial dose is 10 mg / kg of body weight per day.
During treatment, it is necessary to monitor the concentration of ferritin in the blood, based on the changes in this indicator, it is necessary to correct the dose of the remedy every 3 – 6 months.

Treatment with Exjade 250mg should be discontinued with the following indicators:

– iron content 3 mg Fe / g dry matter liver;
– concentration of ferritin less than 300 μg / l.
In the future, if necessary, therapy can be resumed.
In elderly patients, there was an increase in the incidence of adverse reactions. During treatment with Exjade 250mg it is possible to reduce the dose.
Do not need to make a dose adjustment in children and adolescents from 2 to 17 years. You should consider the change in body weight during growth.

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