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 2.5 ml.
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 volume of oral solution suggested in the following table for the body weight of the patient. Sample body weights at 10 kg increments are listed.

Body weight            Total daily dose                 Dose                   ml of oral solution (kg)                     (mg)                (mg, three times/day)          (three times/day) 20                      1500                         500                           5.0
30                      2250                         750                           7.5 40                      3000                        1000                          10.0
50                      3750                        1250                          12.5 60                      4500                        1500                          15.0 70                      5250                        1750                          17.5 80                      6000                        2000                          20.0 90                      6750                        2250                          22.5 
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).

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 measurements fall 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.