IMATINIB MESYLATE TABLETS ARE INDICATED FOR THE TREATMENT OF:
- Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
- Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
- Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
- Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements.
- Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.
- Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1 PDGFRα fusion kinase negative or unknown.
- Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
DOSAGE FORM AND STRENGTHS:
Tablets (scored): 100 mg and 400 mg
DOSAGE AND ADMINISTRATION:
Patients are to take Imatinib Mesylate Tablets exactly as directed by their doctor. For complete details about dosage and administration, please refer the Dosage and Administration section of the Full Prescribing Information.
WARNINGS AND PRECAUTIONS:
- Edema and severe fluid retention have occurred. Weigh patients regularly and manage unexpected rapid weight gain by drug interruption and diuretics.
- 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.
- 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.
- 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.
- Grade 3/4 hemorrhage has been reported in clinical studies in patients with newly diagnosed CML.
- Gastrointestinal perforations, some fatal, have been reported.
- 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).
- Bullous dermatologic reactions (e.g., erythema multiforme and Stevens- Johnson syndrome) have been reported with the use of Imatinib Mesylate.
- Hypothyroidism has been reported in thyroidectomy patients undergoing levothyroxine replacement. Closely monitor TSH levels in such patients.
- Fetal harm can occur when administered to a pregnant woman. Women should be apprised of the potential harm to the fetus.
- 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.
- Tumor lysis syndrome. Close monitoring is recommended.
- Reports of motor vehicle accidents have been received in patients receiving Imatinib Mesylate. Caution patients about driving a car or operating machinery.
PREGNANCY AND BREASTFEEDING:
Imatinib Mesylate can cause harm to the fetus when administered to a pregnant woman. Women should be advised not to become pregnant when taking Imatinib Mesylate. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be made aware of the potential hazard to the fetus. Imatinib Mesylate and its active metabolite are excreted into human milk. Because of the potential for serious adverse reactions in nursing infants from Imatinib Mesylate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Patients are advised to tell their doctor if they experience side effects during Imatinib Mesylate Tablets therapy including fever, shortness of breath, blood in their stools, jaundice, sudden weight gain, symptoms of cardiac failure, or if they have a history of cardiac disease or risk factors for cardiac failure.
The most frequently reported drug-related side effects have been edema, nausea and vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain.
COMPLETE LIST OF WARNINGS AND PRECAUTIONS:
For a complete list of warnings and precautions, adverse reactions, drug interactions, use in specific populations, and over-dosage, please refer to the Full Prescribing Information
REPORT SUSPECT OR ADVERSE SIDE EFFECTS:
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceuticals Industries Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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