Saturday, February 16, 2013

NEWS FROM EXJADE  SURVEYS

"Exjade is dosed based on weight with an initial recommended dose of 20 mg/kg/day
 with later adjustments every 3 – 6 months in steps of 5 or 10 mg/kg/day as needed
 to control serum ferritin levels.  In patients at a dose of 30 mg/kg/day with serum ferritin
levels persistently above 2,500 μg/L, doses up to (but not beyond) 40 mg/kg/day may be
 considered.
In an open-label, noncomparative trial of efficacy and safety of Exjade, 184 patients
 (including 47 MDS patients) were treated for up to 1 year at doses of 5, 10, 20,
or 30 mg/kg/day based on baseline liver iron content (LIC).  The reduction in absolute
LIC from baseline to end of study at 1 year was 4.2 mg-Fe/g-dry weight.
In the primary study of Exjade efficacy – an open-label, randomized, active comparator
 study vs.deferoxamine, 586 patients with β-thalassemia and transfusional hemoiderosis
 were randomized with 296 patients receiving Exjade at doses of 5-30 mg/kg/day and
 treated up to 1 year.
 The following figure summarizes the changes in liver iron content and serum ferritin between
 baseline and end of study at 1 year for Exjade patients at doses of 5, 10, 20, and
30 mg/kg/day."






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