Active Ingredient: Deferoxamine
Treatment for chronic iron overload, e.g.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, between 20 milligrams deferoxamine per kilogram of body weight and 60 milligrams deferoxamine per kilogram of body weight, once daily.
Deferoxamine therapy should be commenced after the first 10-20 blood transfusions, or when serum ferritin levels reach 1000 ng/mL, indicating saturation of the transferrin. The dose and mode of administration should be individually adapted according to the degree of iron overload.
The availability of an intravenous line during blood transfusions makes it possible to administer an intravenous infusion, e.g. in patients who comply poorly with and/or do not tolerate subcutaneous infusions.
Deferoxamine therapy should be commenced after the first 10-20 blood transfusions, or when serum ferritin levels reach 1000 ng/mL, indicating saturation of the transferrin. The dose and mode of administration should be individually adapted according to the degree of iron overload.
Growth retardation may result from iron overload or excessive deferoxamine doses. If chelation is started before 3 years of age growth must be monitored carefully and the mean daily dose should not exceed 40mg/kg.
The lowest effective dose should be used. The average daily dose will probably lie between 20 and 60 mg/kg/day. Patients with serum ferritin levels of <2000 ng/mL should require about 25 mg/kg/day, and those with levels between 2000 and 3000 ng/mL about 35 mg/kg/day. Higher doses should only be employed if the benefit for the patient outweighs the risk of unwanted effects.
Patients with higher serum ferritin may require up to 55 mg/kg/day. It is inadvisable regularly to exceed an average daily dose of 50 mg/kg/day except when very intensive chelation is needed in patients who have completed growth. If ferritin values fall below 1000 ng/mL, the risk of deferoxamine toxicity increases; it is important to monitor these patients particularly carefully and perhaps to consider lowering the total weekly dose.
To assess the chelation therapy, 24 hour urinary iron excretion should initially be monitored daily. Starting with a dose of 500 mg daily the dose should be raised until a plateau of iron excretion is reached. Once the appropriate dose has been established, urinary iron excretion rates can be assessed at intervals of a few weeks.
Alternatively the mean daily dose may be adjusted based on ferritin level in order to keep the therapeutic index below 0.025 (i.e. the mean daily dose (mg/kg) of deferoxamine divided by the serum ferritin level (micro g/L) should be below 0.025). The therapeutic index is a valuable tool in protecting the patient from excess chelation, but it is not a substitute for careful clinical monitoring.
For:
Subcutaneous, between 20 milligrams deferoxamine per kilogram of body weight and 60 milligrams deferoxamine per kilogram of body weight, once daily.
Deferoxamine therapy should be commenced after the first 10-20 blood transfusions, or when serum ferritin levels reach 1000 ng/mL, indicating saturation of the transferrin. The dose and mode of administration should be individually adapted according to the degree of iron overload.
Deferoxamine therapy should be commenced after the first 10-20 blood transfusions, or when serum ferritin levels reach 1000 ng/mL, indicating saturation of the transferrin. The dose and mode of administration should be individually adapted according to the degree of iron overload.
Growth retardation may result from iron overload or excessive deferoxamine doses. If chelation is started before 3 years of age growth must be monitored carefully and the mean daily dose should not exceed 40mg/kg.
The lowest effective dose should be used. The average daily dose will probably lie between 20 and 60 mg/kg/day. Patients with serum ferritin levels of <2000 ng/mL should require about 25 mg/kg/day, and those with levels between 2000 and 3000 ng/mL about 35 mg/kg/day. Higher doses should only be employed if the benefit for the patient outweighs the risk of unwanted effects.
Patients with higher serum ferritin may require up to 55 mg/kg/day. It is inadvisable regularly to exceed an average daily dose of 50 mg/kg/day except when very intensive chelation is needed in patients who have completed growth. If ferritin values fall below 1000 ng/mL, the risk of deferoxamine toxicity increases; it is important to monitor these patients particularly carefully and perhaps to consider lowering the total weekly dose.
To assess the chelation therapy, 24 hour urinary iron excretion should initially be monitored daily. Starting with a dose of 500 mg daily the dose should be raised until a plateau of iron excretion is reached. Once the appropriate dose has been established, urinary iron excretion rates can be assessed at intervals of a few weeks.
Alternatively the mean daily dose may be adjusted based on ferritin level in order to keep the therapeutic index below 0.025 (i.e. the mean daily dose (mg/kg) of deferoxamine divided by the serum ferritin level (micro g/L) should be below 0.025). The therapeutic index is a valuable tool in protecting the patient from excess chelation, but it is not a substitute for careful clinical monitoring.
For:
Intramuscular, between 20 milligrams deferoxamine per kilogram of body weight and 60 milligrams deferoxamine per kilogram of body weight, once daily.
Since the subcutaneous infusions are more effective, intramuscular injections are given only when subcutaneous infusions are not feasible.
The main aim of therapy in well-controlled patients is to maintain an iron balance and prevent haemosiderosis, whilst in overloaded patients a negative iron balance is desirable in order to deplete the increased iron stores and to prevent the toxic effects of iron.
Deferoxamine therapy should be commenced after the first 10-20 blood transfusions, or when serum ferritin levels reach 1000 ng/mL, indicating saturation of the transferrin. The dose and mode of administration should be individually adapted according to the degree of iron overload.
Growth retardation may result from iron overload or excessive deferoxamine doses. If chelation is started before 3 years of age growth must be monitored carefully and the mean daily dose should not exceed 40mg/kg.
The lowest effective dose should be used. The average daily dose will probably lie between 20 and 60 mg/kg/day. Patients with serum ferritin levels of <2000 ng/mL should require about 25 mg/kg/day, and those with levels between 2000 and 3000 ng/mL about 35 mg/kg/day. Higher doses should only be employed if the benefit for the patient outweighs the risk of unwanted effects.
Patients with higher serum ferritin may require up to 55 mg/kg/day. It is inadvisable regularly to exceed an average daily dose of 50 mg/kg/day except when very intensive chelation is needed in patients who have completed growth. If ferritin values fall below 1000 ng/mL, the risk of The main aim of therapy in well-controlled patients is to maintain an iron balance and prevent haemosiderosis, whilst in overloaded patients a negative iron balance is desirable in order to deplete the increased iron stores and to prevent the toxic effects of iron. toxicity increases; it is important to monitor these patients particularly carefully and perhaps to consider lowering the total weekly dose.
To assess the chelation therapy, 24 hour urinary iron excretion should initially be monitored daily. Starting with a dose of 500 mg daily the dose should be raised until a plateau of iron excretion is reached. Once the appropriate dose has been established, urinary iron excretion rates can be assessed at intervals of a few weeks.
Alternatively the mean daily dose may be adjusted based on ferritin level in order to keep the therapeutic index below 0.025 (i.e. the mean daily dose (mg/kg) of deferoxamine divided by the serum ferritin level (micro g/L) should be below 0.025). The therapeutic index is a valuable tool in protecting the patient from excess chelation, but it is not a substitute for careful clinical monitoring.
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