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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

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 ketoconazole, 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 tablets to reduce exposure to iron.

Common side effects of Gleevec tablets

The majority of adult Ph+ CML patients who received Gleevec in clinical studies experienced adverse reactions at some time, but most were mild to moderate in severity. The most frequently reported adverse reactions (all Grades) were superficial edema (60%-74%), nausea (50%-73%), muscle cramps (28%-62%), vomiting (23%-58%), diarrhea (43%-57%), musculoskeletal pain (38%-49%) and rash and related terms (36%-47%).(+)(++)

The overall safety profile of Ph+ CML pediatric patients treated with Gleevec in 93 children studied was similar to that found in studies with adult patients, except that musculoskeletal pain was less frequent (20.5%) and peripheral edema was not reported. Nausea and vomiting were the most commonly reported individual adverse reactions with an incidence similar to that seen in adult patients.

The adverse reactions and safety profile for Ph+ ALL, MDS/MPD, ASM and HES/CEL were generally similar to the safety profile for Ph+ CML.

The most frequently reported drug-related adverse reactions reported in the Ph+ ALL studies were mild nausea, vomiting, diarrhea, myalgia, muscle cramps and rash, which were easily manageable. Superficial edemas were also a common finding in all studies and were described primarily as periorbital or lower-limb edemas. However, these edemas were rarely severe and may be managed with diuretics, other support
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SOURCE Novartis Pharmaceuticals Corporation
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