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Novartis highlights extensive data on numerous compounds at ASCO in multiple cancers, including Phase III studies in GIST and myelofibrosis
Date:5/31/2011

ngestive heart failure and left ventricle dysfunction have been reported, particularly in patients with other health issues and risk factors. Patients with heart disease or risk factors will be monitored and treated for the condition.

Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of Gleevec.

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with Ph+ CML and KIT+ GIST. GI tumor sites may be the cause of this bleeding.

In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell), e.g., HES, MDS/MPD, or ASM and heart involvement, cases of heart disease (cardiogenic shock/left ventricular dysfunction) have been associated with the initiation of Gleevec therapy. Skin reactions, such as fluid-filled blisters, have been reported with the use of Gleevec.

Clinical cases of hypothyroidism (reduction in thyroid hormones) have been reported in patients taking levothyroxine replacement with Gleevec.

Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use.

GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported.

Growth retardation has been reported in children taking Gleevec. The long-term effects of extended treatment with Gleevec on growth in children are unknown.

Cases of tumor lysis syndrome (TLS), which refers to a metabolic and electrolyte disturbance caused by the breakdown of tumor cells, have been reported and can be life-threatening in some cases.

Almost all patients treated with Gleevec experience side effects at some time. Some common side effects you may experience are fluid retention, muscle cramps or pain and bone pai
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