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Significant potential of late- and mid-stage Novartis hematology portfolio to be showcased at upcoming ASH meeting
Date:12/2/2009

s 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 the daily dose of EXJADE by 10 mg/kg if a rise in serum creatinine to >33% above the average of the pretreatment measurements is seen at 2 consecutive visits, and cannot be attributed to other causes. For pediatric patients, reduce the dose by 10 mg/kg if serum creatinine levels rise above the 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
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