Imatinib 400 mg as Imatinib Mesylate INN
Imatinib Mesylate INN
Generic Name: Imatinib Mesylate INN 400 mg Tablet.
Composition: Each film coated tablet contains Imatinib 400 mg as Imatinib Mesylate INN.
Indications:
Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML): Metanib is indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) after Interferon-alpha (IFN) Therapy: Metanib is indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chro nic phase after failure of interferon-alpha therapy.
Adult Patients with Ph+ Acute Lymphoblastic Leukemia (ALL): Metanib is indicated for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Pediatric Patients with Ph+ Acute Lymphoblastic Leukemia (ALL): Metanib is indicated for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
Myelodysplastic/Myeloproliferative Diseases (MDS/MPD): Metanib is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approv ed test.
Aggressive Systemic Mastocytosis (ASM): Metanib is indicated for the treatment of adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutati on as determined with an FDA-approved test.
Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL): Metanib is indicated for the treatment of adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR a fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR a fusion kinase negative or unknown.
Dermatofibrosarcoma Protuberans (DFSP): Metanib is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma pr otuberans.
Kit+ Gastrointestinal Stromal Tumors (GIST): Metanib is indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors.
Adjuvant Treatment of GIST: Metanib is indicated for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.