Exjade(R) Benefits Chronically Transfused Patients by Significantly Reducing Toxic Iron That Can Damage Key Organs, According to Land...(ekly during the first month after initia...),Health

Date:12/8/2008

ekly during the first month after initiation or modification of therapy and monthly thereafter. Nonprogressive increases in serum creatinine have been noted in 38% of EXJADE-treated patients, compared to 14% of deferoxamine-treated patients in Study 1 and 36% vs 22%, respectively in Study 3, and appear to be dose related. These increases were within the normal range in 94% of patients. EXJADE dosages were adjusted when serum creatinine elevations were detected during the study.

Consider dose reduction, interruption, or discontinuation for elevations in serum creatinine. For adult patients, reduce daily dose of Exjade by 10 mg/kg if rise in serum creatinine to > 33% above average of the pretreatment measurements is seen at 2 consecutive visits, and cannot be attributed to other causes. For pediatric patients, reduce dose by 10 mg/kg if serum creatinine levels rise above age-appropriate upper limit of normal at 2 consecutive visits. If there is a progressive increase in serum creatinine beyond the age-appropriate upper limit of normal, interrupt EXJADE use. Once the creatinine has returned to within the normal range, therapy with EXJADE may be reinitiated at a lower dose followed by gradual dose escalation, if the clinical benefit is expected to outweigh potential risks.

Intermittent proteinuria (urine protein/creatinine ratio >0.6 mg/mg) occurred in 18.6% of EXJADE-treated patients, compared to 7.2% of deferoxamine-treated patients in Study 1, and monthly monitoring is recommended.

There have been postmarketing reports of cytopenias (including agranulocytosis, neutropenia and thrombocytopenia) in patients treated with EXJADE. Some of these patients died. The relationship of these episodes to treatment with EXJADE is uncertain. Most of these patients had pre-existing hematologic disorders that are frequently associated with bone marrow failure. In line with standard clinical management, monitor b
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SOURCE Novartis Pharmaceuticals Corporation Copyright©2008 PR Newswire. All rights reserved

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