More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline... (be used for patients with severe hepatic...)

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More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

Date:12/3/2008

be used for patients with severe hepatic impairment. Patients with moderate renal impairment (CrCL = 20-39 mL/min) should receive a 50% decrease in the recommended starting dose and increased as tolerated. Doses greater than 600 mg are not recommended in patients with mild renal impairment (CrCL = 40-59 mL/min). For patients with moderate renal impairment doses greater than 400 mg are not recommended. Gleevec should be used with caution in patients with severe renal impairment.

Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening. There have also been reports, including fatalities, of cardiac tamponade, cerebral edema, acute respiratory failure and GI perforation.

Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have also been reported. In some cases, the reaction recurred upon re-challenge. Several post-marketing reports describe patients able to tolerate the reintroduction of Gleevec at a lower dose with or without concomitant corticosteroids or antihistamines following resolution or improvement of the bullous reaction.

Consider potential toxicities--specifically liver, kidney and cardiac toxicity, and immunosuppression from long-term use.

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 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 tablet to reduc
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