More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline... (mg/kg if rise in serum creatinine to >...)

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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

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 post-marketing 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 blood counts regularly. Consider interrupting treatment with Exjade in patients who develop unexplained cytopenia. Reintroduction of therapy with Exjade may be considered once the cause of the cytopenia has been elucidated.

There have been post-marketing reports of hepatic failure, some with a fatal outcome, in patients treated with Exjade. Most of these events occurred in patients greater than 55 years of age. Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis and multi-organ failure. Monitor liver function tests monthly during Exjade treatment and consider dose modifi
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SOURCE Novartis Pharmaceuticals Corporation
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More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline...(mg/kg if rise in serum creatinine to >...),Health