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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Edema and severe fluid retention have occurred. Weigh patients regularly and manage unexpected rapid weight gain by drug interruption and diuretics. (5.1, 6.1) • Cytopenias, particularly anemia, neutropenia, and thrombocytopenia, have occurred. Manage with dose reduction, dose interruption, or 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. Monitor and treat patients with cardiac disease or risk factors for cardiac failure. (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 (GI) perforations, some fatal, have been reported. (5.6) • Cardiogenic shock/left ventricular dysfunction has been associated with the initiation of imatinib mesylate 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 imatinib mesylate. (5.8) • Hypothyroidism has been reported in thyroidectomy patients undergoing levothyroxine replacement. Closely monitor TSH levels in such patients. (5.9) • Fetal harm can occur when administered to a pregnant woman. Apprise women of the potential harm to the fetus, and to use effective contraception. (5.10, 8.1) • Growth retardation occurring in children and pre-adolescents receiving imatinib mesylate has been reported. Close monitoring of growth in children under imatinib mesylate treatment is recommended. (5.11 , 6.2) • Tumor Lysis Syndrome. Close monitoring is recommended. (5.12) • Reports of motor vehicle accidents have been received in patients receiving imatinib mesylate. Caution patients about driving a car or operating machinery. (5.13) • Renal Toxicity. A decline in renal function...
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adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Fluid Retention and Edema [see Warnings and Precautions ( 5.1 )] • Hematologic Toxicity [see Warnings and Precautions ( 5.2 )] • Congestive Heart Failure and Left Ventricular Dysfunction [see Warnings and Precautions ( 5.3 )] • Hepatotoxicity [see Warnings and Precautions ( 5.4 )] • Hemorrhage [see Warnings and Precautions ( 5.5 )] • Gastrointestinal Disorders [see Warnings and Precautions ( 5.6 )] • Hypereosinophilic Cardiac Toxicity [see Warnings and Precautions ( 5.7 )] • Dermatologic Toxicities [see Warnings and Precautions ( 5.8 )] • Hypothyroidism [see Warnings and Precautions ( 5.9 )] • Growth Retardation in Children and Adolescents [see Warnings and Precautions ( 5.11 )] • Tumor Lysis Syndrome [see Warnings and Precautions ( 5.12 )] • Impairments Related to Driving and Using Machinery [see Warnings and Precautions ( 5.13 )] • Renal Toxicity [see Warnings and Precautions ( 5.14 )] The most frequently reported adverse reactions (greater than or equal to 30%) are edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Chronic Myeloid Leukemia The majority of imatinib mesylate-treated patients experienced adverse reactions at some time. Imatinib mesylate was discontinued due to drug-related adverse reactions in 2.4% of patients receiving imatinib mesylate in the randomized trial of newly diagnosed patients with Ph+ CML in chronic phase comparing imatinib mesylate versus IFN+Ara-C, and in 12.5% of patients receiving imatinib mesylate in the randomized trial of newly diagnosed patients with Ph+ CML in chronic phase comparing imatinib mesylate and nilotinib. Imatinib mesylate was discontinued due to drug-related adverse reactions in 4% of patients in chronic phase after failure of interferon-alpha therapy, in 4% of patients in accelerated phase and in 5% of patients in blas...