- KIT+ GIST
- Ph+ CML
- Rare Diseases
Always consider benefits and risks when making a treatment decision
|Serious adverse reactions to GLEEVEC® (imatinib mesylate)|
|Fluid retention and edema||Patients should be weighed and monitored regularly for signs and symptoms of edema or serious fluid retention. Severe fluid retention was reported in 9% to 13.1% of patients with KIT+ GIST. If severe fluid retention occurs, manage with diuretic therapy and withhold GLEEVEC until the event has resolved and then resume depending on the initial severity of the event.|
|Hematologic toxicity||Cytopenias, including anemia, neutropenia, and thrombocytopenia, have been reported. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (eg, every 2-3 months). Dose reduction, treatment interruption, or in rare cases discontinuation of treatment may be required for severe neutropenia or thrombocytopenia.|
|Severe congestive heart failure and left ventricular dysfunction||Severe congestive heart failure and left ventricular dysfunction have been reported in patients taking GLEEVEC. Patients with cardiac disease or renal failure, risk factors for cardiac failure, or history of renal failure should be monitored carefully. Patients with signs or symptoms should be evaluated and treated.|
|Hepatotoxicity||Severe hepatotoxicity, including fatalities, may occur with both short-term and long-term use. Assess liver function before initiation of treatment and monitor monthly thereafter, or as clinically indicated. Dose adjustments or drug interruption may be required. A 25% decrease in the recommended dose should be used for patients with severe hepatic impairment.|
|Hemorrhage||In the Phase 3 unresectable or metastatic GIST studies, 13% of patients reported NCI Grades 3/4 hemorrhage at any site. In the Phase 2 unresectable or metastatic GIST study, 5% of patients reported severe gastrointestinal (GI) and/or intratumoral bleeds. GI tumor sites may have been the source of GI bleeds; therefore, GI symptoms should be monitored at the start of therapy.|
|Gastrointestinal disorders||GLEEVEC should be taken with food and a large glass of water to minimize possible GI irritation. There have been rare reports, including fatalities, of GI perforation.|
|Hypereosinophilic cardiac toxicity||In patients with hypereosinophilic syndrome with occult infiltration of HES cells within the myocardium, cardiogenic shock and left ventricular dysfunction have been associated with HES cell degranulation upon initiation of GLEEVEC. The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures, and temporarily withholding GLEEVEC.|
|Dermatologic toxicities||Bullous dermatologic reactions, including erythema multiforme and Stevens-Johnson syndrome, have been reported.|
|Hypothyroidism||Hypothyroidism has been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with GLEEVEC. TSH levels should be closely monitored.|
|Toxicities from long-term use||Consider potential toxicities—specifically liver, kidney, and cardiac toxicity—and immunosuppression.|
|Fetal harm||Fetal harm can occur when administered to a pregnant woman; therefore, women of reproductive potential should be advised to not become pregnant and use highly effective contraception while taking GLEEVEC. Breastfeeding should be avoided while taking GLEEVEC because of the potential for serious adverse reactions in nursing infants.|
|Growth retardation||Growth retardation has been reported in children and preadolescents receiving GLEEVEC. The long-term effects of prolonged treatment with GLEEVEC on growth in children are unknown; therefore, monitoring of growth in children taking GLEEVEC is recommended.|
|Tumor lysis syndrome||Cases of tumor lysis syndrome (TLS), including fatal cases, have been reported. Patients with tumors having a high proliferative rate or high tumor burden prior to treatment should be monitored closely for TLS. Correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of GLEEVEC.|
|Dizziness, blurred vision, and somnolence||Motor vehicle accidents involving patients receiving GLEEVEC have been reported. Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision, or somnolence during treatment with GLEEVEC. Caution should be recommended when driving a car or operating machinery.|
GLEEVEC® (imatinib mesylate) tablets are indicated for:
Important Safety Information
Common Side Effects of GLEEVEC Tablets
*For more detailed study information, please see full Prescribing Information.
†Numbers indicate the range of percentages in 4 studies among adult patients, with newly diagnosed Ph+ CML, patients in blast crisis, accelerated phase, and in the chronic phase after failure of interferon-alpha therapy.
Novartis offers 2 options for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Click on GLEEVEC.com to continue to learn about GLEEVEC® (imatinib mesylate) or click the box below to learn more about another option.
that is available for newly diagnosed patients in the chronic phase or patients who are no longer responding or are intolerant to GLEEVEC.