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Positive Results Prompt US National Cancer Institute to Make,Gleevec Available To Patients in Post-Surgical Gist Study

strating a clinical benefit, such as improvement in disease-related symptoms or increased survival

Important Safety Information(1)

Severe (NCI Grades 3/4) lab abnormalities (400 mg/day; 600 mg/day)- including neutropenia (10%; 11%), anemia (3%; 9%), thrombocytopenia (0%; 1%), and hepatotoxicity (6%; 8%)-and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (eg, pleural effusion or ascites; 3%; 8%) and superficial edema (6%; 5%), hemorrhage (6%; 11%), abdominal pain (11%; 4%), nausea (6%; 4%), diarrhea (3%; 7%), and musculoskeletal pain (6%; 1%) were reported among patients receiving Gleevec

Some patients (5%) were reported to have severe GI bleeds and/or intratumoral bleeds. GI tumor sites may have been the source of GI bleeds

Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening. There have also been reports, including fatalities, of cardiac tamponade, cerebral edema, increased intracranial pressure, papilledema, and gastrointestinal (GI) perforation

Severe congestive heart failure and left ventricular dysfunction have occasionally been reported. Most of the patients with reported cardiac events have had other comorbidities and risk factors, including advanced age and previous medical history of cardiac disease. Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated

Bullous dermatologic reactions (eg, erythema multiforme and Stevens- Johnson syndrome) have also been reported. In some cases, the reaction recurred upon rechallenge. Several postmarketing reports describe patients able to tolerate the reintroduction of Gleevec at a lower dose with or without concomitant corticosteroids or antihistamines following resolution or improvement of the bullous reaction

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