Most Non-Hematologic Adverse Events Less Common With Gleevec®1,2

• In the Gleevec group, most adverse events were mild to moderate (grades 1/2). The most

common adverse events (all grades; ≥25%) were superficial edema (53%), nausea (43%),

muscle cramps (35%), musculoskeletal pain (34%), rash (32%), fatigue (31%), diarrhea (30%),

headache (29%), and joint pain (27%).

• No severe (grades 3/4) non-hematologic event occurred in more than 3% of patients receiving

Gleevec.

• In the IFN-α + ara-C group, the most common adverse events (all grades; ≥25%) were fatigue

(65%), nausea (61%), headache (42%), diarrhea (41%), musculoskeletal pain (41%), myalgia

(39%), pyrexia (39%), joint pain (38%), depression (35%), rigors (34%), anorexia (31%),

vomiting (27%), and rash (25%).

• Severe (grades 3/4) fatigue, depression, myalgia, and musculoskeletal pain were observed in

24%, 12%, 8%, and 8% of patients receiving IFN-α + ara-C, respectively.

• Severe lab abnormalities—including neutropenia (14%), thrombocytopenia (7%),anemia (3%), and hepatotoxicity (3%)—severe musculoskeletal pain (3%), fluid retention (including severe

superficial edema) (<1%),* and hemorrhage (<1%) were reported among some Gleevec

recipients.

*Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life threatening.

References

1. Gleevec® (imatinib mesylate) Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals

Corporation; 2003.

2. Data on file. Novartis Pharmaceuticals Corporation, East Hanover, NJ.