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More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies
Date:12/3/2008

ts 2 years of age and older. Further studies are being performed to determine the long-term benefits and risks of Exjade.

Exjade is contraindicated in patients with hypersensitivity to deferasirox or to any other component of Exjade.

Cases of acute renal failure, some with a fatal outcome, have been reported following the post-marketing use of Exjade. Most of the fatalities occurred in patients with multiple comorbidities and who were in advanced stages of their hematologic disorders. There have also been reports of renal tubulopathy in patients treated with Exjade. Give particular attention to monitoring serum creatinine in patients who: are at increased risk of complications, have pre-existing renal conditions, are elderly, have comorbid conditions, or are receiving medicinal products that depress renal function.

Assess serum creatinine in duplicate before initiating therapy to establish a reliable pretreatment baseline, due to variations in measurements. Monitor serum creatinine monthly thereafter. In patients with additional renal risk factors (those who are at increased risk of complications, have pre-existing renal conditions, are elderly, have comorbid conditions, or are receiving medicinal products that depress renal function), monitor serum creatinine weekly 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
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SOURCE Novartis Pharmaceuticals Corporation
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