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FDA approves Novartis drug Gleevec® label recommending extending treatment to three years for certain GIST patients after surgery
Date:2/1/2012

patients with KIT+ GIST. GI tumor sites may be the cause of this bleeding; therefore, GI symptoms should be monitored at the start of treatment.

In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell) 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. Correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Gleevec.

Reports of motor vehicle accidents have been received in patients receiving Gleevec; patients are cautioned about driving a car or operating machinery.

Almost all patients with KIT+ GIST 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 pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.

Gleevec is sometimes associated with stomach or intestinal
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