Imatinib mesylate is a kinase inhibitor 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 (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy…
From the U.S. FDA-approved label for Imatinib. Full label: DailyMed.
Imatinib mesylate is a kinase inhibitor 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 (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy, Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy, Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements., Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown…
From the U.S. FDA-approved label for Imatinib. Full label: DailyMed.
Adults with Ph+ CML CP: 400 mg/day Adults with Ph+ CML AP or BC: 600 mg/day Pediatrics with Ph+ CML CP: 340 mg/m 2 /day Adults with Ph+ ALL: 600 mg/day Pediatrics with Ph+ ALL 340 mg/m 2 /day Adults with MDS/MPD: 400 mg/day Adults with ASM: 100 mg/day or 400 mg/day Adults with HES/CEL: 100 mg/day or 400 mg/day Adults with DFSP: 800 mg/day Adults with metastatic and/or unresectable GIST: 400 mg/day Adjuvant treatment of adults with GIST: 400 mg/day Patients with mild to moderate hepatic impairment: 400 mg/day Patients with severe hepatic impairment: 300 mg/day All doses of imatinib mesylate tablets should be taken with a meal and a large glass of water.
Directions from the U.S. FDA-approved label — your doctor or pharmacist may advise differently.
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, dose interruption, or 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.
Warnings and precautions excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor before use.
The following serious adverse reactions are described elsewhere in the labeling: Fluid Retention and Edema Hematologic Toxicity Congestive Heart Failure and Left Ventricular Dysfunction Hepatotoxicity Hemorrhage Gastrointestinal Disorders Hypereosinophilic Cardiac Toxicity Dermatologic Toxicities Hypothyroidism Growth Retardation in Children and Adolescents Tumor Lysis Syndrome Impairments Related to Driving and Using…
Excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor about side effects.
Store at 20ºC to 25ºC (68ºF to 77ºF); Protect from moisture.
Storage information from the U.S. FDA-approved label.
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