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  • IMAXEN
IMAXEN (Imatinib 400 mg)
Therapeutic Class: Hematology
Pack Size: Each HDPE container contains 14 film coated tablets each of which contains Imatinib Mesilate BP equivalent to Imatinib 400 mg

INDICATION


• 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-PDG- FRa 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.