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Early Data Show Potential for Imatinib Mesylate Tablets to Treat Life-Threatening Form of Pulmonary Artery Disease
Date:10/8/2008

ive measures, or, in some patients, by reducing the dose of Gleevec.

Frequently reported adverse reactions (all Grades) in the seven MDS/MPD patients assessed were nausea (57%); diarrhea and muscle cramps (43% each); anemia, fatigue, arthralgiaand periorbital edema (29% each).

All ASM patients experienced at least one adverse reaction at some time. The most frequently reported adverse reactions were diarrhea, nausea, ascites, muscle cramps, dyspnea, fatigue, peripheral edema, anemia, pruritus, rash and lower respiratory tract infection.

All HES/CEL patients experienced at least one adverse reaction, the most common being gastrointestinal, cutaneous and musculoskeletal disorders. Hematologic abnormalities were also frequent, with instances of Grade 3 leukopenia, neutropenia, lymphopenia and anemia.

Frequently reported adverse reactions (all Grades) in the 12 DFSP patients assessed included nausea and fatigue (42% each); periorbital, peripheral and eye edema (33% each); diarrhea, vomiting, rash, lacrimation increased and anemia (25% each); face edema, pyrexia, exertional dyspnea, rhinitis, and anorexia (17% each).

The majority of patients who received Gleevec in the GIST study experienced adverse reactions at some time. Most adverse reactions were mild to moderate in severity. The most frequently reported adverse reactions (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-to-moderate adverse reactions so that the prescribed dose can be maintained whenever possible. However, in some cases, either a dose reduction or interruption of treatment with Gleevec may be necessary.

Gleevec tablets should be taken with food and a lar
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SOURCE Novartis Pharmaceuticals Corporation
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