Cytopenias, particularly anemia, neutropenia, and thrombocytopenia, have occurred. Manage with dose reduction or dose interruption and in rare cases discontinuation of treatment. Perform complete blood counts weekly for the first month, biweekly for the second month, and periodically thereafter (5.2)

Severe congestive heart failure and left ventricular dysfunction have been reported, particularly in patients with comorbidities and risk factors. Patients with cardiac disease or risk factors for cardiac failure should be monitored and treated (5.3)

Severe hepatotoxicity including fatalities may occur. Assess liver function before initiation of treatment and monthly thereafter or as clinically indicated. Monitor liver function when combined with chemotherapy known to be associated with liver dysfunction (5.4)

Grade 3/4 hemorrhage has been reported in clinical studies in patients with newly diagnosed CML and with GIST. GI tumor sites may be the source of GI bleeds in GIST (5.5)

Gastrointestinal perforations, some fatal, have been reported (5.6)

Cardiogenic shock/left ventricular dysfunction has been associated with the initiation of Gleevec in patients with conditions associated with high eosinophil levels (e.g., HES, MDS/MPD and ASM) (5.7)

Bullous dermatologic reactions (e.g., erythema multiforme and Stevens-Johnson syndrome) have been reported with the use of Gleevec (5.8)

Hypothyroidism has been reported in thyroidectomy patients undergoing levothyroxine replacement. Closely monitor TSH levels in such patients (5.9).

Consider potential toxicities, specifically, liver, kidney, and cardiac toxicity, and immunosuppression from long-term use (5.10)

Fetal harm can occur when administered to a pregnant woman. Women should be apprised of the potential harm to the fetus (5.11, 8.1)

Growth retardation occurring in children and pre-adolescents receiving Gleevec has been reported. Close monitoring of growth in children under Gleevec treatment is recommended (5.12, 6.13)

Tumor lysis syndrome. Close monitoring is recommended (5.13)

 
ADVERSE REACTIONS
The most frequently reported adverse reactions (>30%) were edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue and abdominal pain (6.1, 6.11)

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 
DRUG INTERACTIONS
CYP3A4 inducers may decrease Gleevec Cmax and AUC (2.9, 7.1)

CYP3A4 inhibitors may increase Gleevec Cmax and AUC (7.2)

Gleevec is an inhibitor of CYP3A4 and CYP2D6 which may increase the Cmax and AUC of other drugs (7.3, 7.4)

Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin (7.3)

 
USE IN SPECIFIC POPULATIONS
There is no experience in children less than 2 years of age (8.4)

See 17 for PATIENT COUNSELING INFORMATION 

Revised: 04/2011
 

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