Imaceva^TM

Indication:
Imaceva^TM is 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 as determined with an FDA-approved test.
• Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown.
• Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα 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.

Dosage & Administration:
The recommended dose for Imatinib are: • 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/m2/day; • Adults with Ph+ALL: 600 mg/day; • Pediatrics with Ph+ALL: 340 mg/m2/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.

Preparation:
Imaceva^TM 100: Each box contains 3 blister of 10 tablets.
Imaceva^TM 400: Each box contains 3 blister of 10 tablets.