(*)Numbers indicate the range of percentages in 4 studies among adult patients with Ph+ CML in blast crisis, accelerated phase, and chronic phase.
For DFSP, severe (NCI Grades 3/4) lab abnormalities included anemia (17%), thrombocytopenia (17%), neutropenia (8%) and increased creatinine (8%).
In GIST, 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.
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.
Dose adjustments may be necessary due to hepatotoxicity, other
nonhematologic adverse reactions, or hematologic adverse reactions. Therapy
with Gleevec was discontinued for drug-related adverse reactions in 2.4% to
5% of adult patients with Ph+ CML and for adverse reactions in 5% of KIT+
GIST patients. None of the 5 patients in the ASM study discontinued Gleevec
due to drug-related events or abnormal laboratory values. Complete blood
counts should be performed weekly for the first month, biweekly for the
second month, and periodically thereafter as clinically indicated (for
|SOURCE Novartis Pharmaceuticals Corporation|
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