ioxamine resulted in plasma steady state levels of desferrioxamine of 7.4 micro mol/L. Elimination of desferrioxamine from plasma was biphasic with a mean distribution half-life of 0.28 hours and an apparent terminal half-life of 3.0 hours. The total plasma clearance was 0.5 L/h/kg and the volume of distribution at steady state was estimated at 1.35 L/kg. Exposure to the main iron binding metabolite was around 54% of that of desferrioxamine in terms of AUC. The apparent monoexponential elimination half-life of the metabolite was 1.3 hours.
Clinical studies
Desferrioxamine was used as a comparator in a randomized, one-year clinical trial investigating the use of another iron chelator (deferasirox) in patients with beta-thalassemia and transfusional hemosiderosis. A total of 290 patients were treated with subcutaneous desferrioxamine at starting doses of 20 to 60 mg/kg for 5 days per week. The study showed a dose-dependent effect of desferrioxamine on serum ferritin levels, liver iron concentration and iron excretion rate.
Desferrioxamine was also used as a comparator in a second open-label, randomized, one-year trial investigating the use of deferasirox in patients with sickle cell disease and transfusional hemosiderosis. A total of 63 patients were treated with subcutaneous desferrioxamine at starting doses of 20 to 60 mg/kg at least 5 days per week. At the end of the study, the mean change in liver iron concentration (LIC) was -0.7 mg Fe/g dry weight.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
6. Pharmaceutical particulars
6.1 List of excipients
None present.
6.2 Incompatibilities
None known.
6.3 Shelf life
18 months.
6.4 Special precautions for storage
Vial: Do not store above 30°C.
Reconstituted solution : Single use only.
From a microbiological point of view, the product should be used immediately after reconstitution (commencement of treatment within 3 hours). When the reconstitution is carried out under validated aseptic conditions the reconstituted solution may be stored for a maximum of 24 hours at room temperature (25°C or below) before administration. If not used immediately, in-use storage times and conditions prior to administration are the responsibility of the user. Unused solution should be discarded.
6.5 Nature and contents of container
Each vial contains a white to practically white lyophilisate supplied in a clear glass vial in a pack size of 10 (500 mg) or 1 (2 g).
6.6 Special precautions for disposal and other handling
None stated.
7. Marketing authorisation holder
Novartis Pharmaceuticals UK Limited
Trading as Ciba Laboratories
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
8. Marketing authorisation number(s)
PL 00101/0523.
9. Date of first authorisation/renewal of the authorisation
31 October 1997 / 12 December 2000
10. Date of revision of the text
03 November 2016
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