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Imatinib mesylate is a small molecule protein Tyrosine Kinase Inhibitor. It inhibits the activity of several tyrosine kinases: c-KIT, the receptor for stem cell factor coded by the c-Kit proto-oncogene, the Platelet-Derived Growth Factor Receptors (PDGFR), the Abl family of non-receptor tyrosine kinases consisting of Abl and Arg (the Abl-related gene), and c-Fms, the receptor for macrophage-stimulating factor. Malignancies mediated through these pathways are the primary target for Imatinib.
Imatinib 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 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-PDGFR fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR fusion kinase negative or unknown.
- Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
- Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
- Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.
Tyronib 100 mg tablet: Each commercial box contains 30 tablets in Alu-Alu blister pack.
Tyronib 400 mg tablet: Each commercial box contains 30 tablets in Alu-Alu blister pack.