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

y be necessary due to hepatotoxicity, other nonhematologic adverse events, or hematologic adverse events. Therapy with Gleevec was discontinued for adverse events in 5% of patients at both dose levels studied

Patients with severe hepatic impairment should be treated at a starting dose of 300 mg/day and should be closely monitored

Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6, and CYP2C9. Dosage of Gleevec should increase by at least 50%, and clinical response should be carefully monitored, in patients receiving Gleevec with a potent CYP3A4 inducer such as rifampin or phenytoin. Examples of commonly used drugs that may significantly interact with Gleevec include acetaminophen, warfarin, erythromycin, and phenytoin. (Please see full Prescribing Information for other potential drug interactions)

For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablet to reduce exposure to iron

Use of Gleevec tablets is contraindicated in patients with hypersensitivity to imatinib or to any other component of Gleevec tablets

Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec tablets and should be advised to avoid breast- feeding while taking Gleevec tablets because of the potential for serious adverse reactions in nursing infants

Common Side Effects of Gleevec Tablets

The majority of patients who received Gleevec in the GIST study experienced adverse events at some time. Most adverse events were mild to moderate in severity. The most frequently reported adverse events (400 mg/day; 600 mg/day) (all Grades) were superficial edema (81%; 77%), nausea (63%; 74%), muscle cramps (47%; 58%), diarrhea (59%; 70%), fatigue (48%; 53%), abdominal pain (40%; 37%), rash and related terms (38%; 53%), vomiting (38%; 35%) musculoskeletal pain (37%; 30%), and hemorrhage (26%; 34%)**

Supportive care may help management of some mild
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