This package insert provides additional information about Desferal.
Leaflet informs about Desferal composition, usage, dosage, side effects, interactions, indications, contraindications, overdosage instructions, adverse reactions, pharmacological properties, procedure for use, dependence possibility.
This Desferal patient brochure is not intended to be a substitute for professional medical advice, diagnosis, or treatment.
Consult your doctor or pharmacist before using Desferal.
Active substance: N-[5-(3-[(5-aminopentyl)-hydroxycarbamoyl]-propionami do)pentyl]-3-
([5-(N-hydroxyacetamido)-pentyl]-carbamoyl)propionohydroxamic acid monomethane sulphonate (= desferrioxmine methane sulphonate).
Vials containing 500 mg or 2 g dry active substance for injection.
Monotherapy iron chelation treatment for chronic iron overload, e.g.
• transfusional haemosiderosis, as seen in thalassaemia major, sideroblastic anaemia, auto-immune haemolytic anaemia, and other chronic anaemias;
• idiopathic (primary) haemochromatosis in patients in whom concomitant disorders (e.g. severe anaemia, cardiac disease, hypoproteinaemia) preclude phlebotomy.
• iron overload associated with prophyria cutanea tarda in patients unable to tolerate phlebotomy.
Treatment for acute iron poisoning.
Treatment for chronic aluminium overload in patients with end-stage renal failure (under maintenance dialysis) with
• aluminium-related bone disease
• dialysis encephalopathy or
• aluminium-related anaemia
• iron mobilization with Desferal is relatively poor in patients under the age of 3 years with relatively little iron overload. The drug should ordinarily not be given to such patients unless significant iron mobilization (e.g. 1 mg or more of iron per day) can be demonstrated.
Diagnosis of iron or aluminium overload.
Desferal dosage and administration
Treatment for chronic iron overload
The main aim of chelation therapy in iron overload in young patients is to achieve an iron balance and to prevent haemosiderosis, while in the older patients a negative iron balance is desirable in order to reduce slowly the increased iron stores and to prevent the toxic effects of iron.
Children and adults
It is recommended that therapy with Desferal® be started after the first 10-20 blood transfusions or when the serum ferritin level reached 1000 ng/mL. Growth retardation may result from iron overload or excessive Desferal doses. If chelation is begun before 3 years of age growth must be monitored carefully and the mean daily dose should not exceed 40 mg/kg. The dosage and the mode of administration may be individually determined and adapted during the course of therapy according to the severity of the patient’s iron burden. The lowest effective dosage should be used. To assess the response to 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. For estimation of the patient’s total iron stores, the best method is accurate recording of the amount of iron received through transfusions, supplemented by serum ferritin determination. Based on the amount of iron excreted in the urine, the individual iron balance can be calculated. A negative iron balance is considered to be present when the total amount of iron excreted in the urine, plus a further 50% (which roughly corresponds to the mean iron excretion in the faeces), exceeds the total iron received by blood transfusion. Chelation therapy is considered satisfactory when serum ferritin levels are close to normal (≤ 300 µg/l).