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These brands contain the same active ingredient (Imatinib Mesylate). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
Indications & Uses
Tyronib is indicated in- 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 in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. ... Read moreTyronib is indicated in- 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 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). Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. Adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown. Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR a fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown. Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans. Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors. Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Adults with Ph+ CML CP: 400 mg/dayAdults with Ph+ CML AP or BC: 600 mg/dayPediatrics with Ph+ CML CP: 340 mg/m2/dayAdults with Ph+ ALL: 600 mg/dayPediatrics with Ph+ ALL: 340 mg/m2/dayAdults with MDS/MPD: 400 mg/dayAdults with ASM: 100 mg/day or 400 mg/dayAdults with HES/CEL: 100 mg/day or 400 mg/dayAdults with DFSP: 800 mg/dayAdults with metastatic and/or unresectable GIST: 400 mg/dayAdjuvant treatment of adults with GIST: 400 mg/dayPatients with mild to moderate hepatic impairment: 400 mg/dayPatients with severe hepatic impairment: 300 mg/dayAll doses of Imatinib should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Imatinib can be dissolved in water or apple juice for patients having difficulty swallowing. Daily dosing of 800 mg and above should be accomplished using the 400-mg tablet to reduce exposure to iron.
Side Effects
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 Machinery Renal Toxicity
Cautions & Contraindications
Warnings & 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, 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. Monitor and treat patients with cardiac disease or risk factors for cardiac failure. 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 and with GIST. Gl tumor sites may be the source of Gl bleeds in GIST. Gastrointestinal (Gl) perforations, some fatal, have been reported. Cardiogenic shock/left ventricular dysfunction has been associated with the initiation of Tyronib 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 Tyronib. Hypothyroidism has been reported in thyroidectomy ZyvaxatX patients undergoing levothyroxine replacement. Closely monitor TSH levels in such patients. Fetal harm can occur when administered to a pregnant woman. Apprise women of the potential harm to the fetus, and to avoid pregnancy when taking Tyronib. Growth retardation occurring in children and pre-adolescents receiving Tyronib has been reported. Close monitoring of growth in children under Tyronib treatment is recommended. Tumor Lysis Syndrome. Close monitoring is recommended. Reports of motor vehicle accidents have been received in patients receiving Tyronib. Caution patients about driving a car or operating machinery. Renal Toxicity. A decline in renal function may occur in patients receiving Tyronib. Evaluate renal function at baseline and during therapy, with attention to risk factors for renal dysfunction.