Posology : מינונים

4.2    Posology and method of administration

Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia.

Posology
Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight. Dose per kilogram body weight should be calculated to the nearest half tablet. See table below for recommended doses for body weights at 10 kg increments.


Dose table
To obtain a dose of about 75 mg/kg/day, use the number of tablets suggested in the following tables for the body weight of the patient. Sample body weights at 10 kg increments are listed.

Dose table for Ferriprox Tablets 500 mg

Body weight            Total daily dose                   Dose                  Number of tablets (kg)                    (mg)                  (mg, three times/day)         (three times/day) 20                     1500                           500                          1.0
30                     2250                           750                          1.5 40                     3000                          1000                          2.0
50                     3750                          1250                          2.5 60                     4500                          1500                          3.0 70                     5250                          1750                          3.5 80                     6000                          2000                          4.0 90                     6750                          2250                          4.5 
Dose table for Ferriprox Tablets 1000 mg

Number of 1000 mg tablets*
Body weight     Total daily dose
(kg)             (mg)                Morning               Midday                 Evening 
20                1500                   0.5                  0.5                   0.5
30                2250                   1.0                  0.5                   1.0 40                3000                   1.0                  1.0                   1.0
50                3750                   1.5                  1.0                   1.5 60                4500                   1.5                  1.5                   1.5 70                5250                   2.0                  1.5                   2.0 80                6000                   2.0                  2.0                   2.0 90                6750                   2.5                  2.0                   2.5 *number of tablets rounded to nearest half tablet

A total daily dose above 100 mg/kg body weight is not recommended because of the potentially increased risk of adverse reactions (see sections 4.4, 4.8, and 4.9).


Dose adjustment
The effect of Ferriprox in decreasing the body iron is directly influenced by the dose and the degree of iron overload. After starting Ferriprox therapy, it is recommended that serum ferritin concentrations, or other indicators of body iron load, be monitored every two to three months to assess the long-term effectiveness of the chelation regimen in controlling the body iron load. Dose adjustments should be tailored to the individual patient’s response and therapeutic goals (maintenance or reduction of body iron burden). Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 g/l.

Paediatric population
There are limited data available on the use of deferiprone in children between 6 and 10 years of age, and no data on deferiprone use in children under 6 years of age.
Method of administration
For oral use