Imanix 400

Acute Lymphoblastic Leukemia
Indicated for adults with relapsed or refractory Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)
600 mg PO qDay

Myelodysplastic/Myeloproliferative Diseases
Indicated in adults with myelodysplastic/ myeloproliferative diseases associated with platelet-derived growth factor receptor gene re-arrangements as determined with an FDA-approved test
400 mg PO qDay

Hypereosinophilic Syndrome/Eosinophilic Leukemia
Indicated for adults with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFR-alpha fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR-alpha fusion kinase negative or unknown
400 mg PO qDay

In patients with demonstrated F1P1L1-PDGFR-alpha fusion kinase: 100 mg PO qDay; may increase to 400 mg qDay in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy

Chronic Myeloid Leukemia
Chronic phase
Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
400 mg PO qDay

Chronic phase after failure of interferon-alpha therapy: May increase to 600 mg/day in the absence of severe adverse drug reaction and severe nonleukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time), failure to achieve a satisfactory hematologic response after at least 3 months of treatment, failure to achieve a cytogenetic response after 6-12 months of treatment, or loss of a previously achieved hematologic or cytogenetic response

Accelerated phase or blast crisis
600 mg PO qDay
May increase to 400 mg PO q12hr in the absence of severe adverse drug reaction and severe nonleukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time), failure to achieve a satisfactory hematologic response after at least 3 months of treatment, failure to achieve a cytogenetic response after 6-12 months of treatment, or loss of a previously achieved hematologic or cytogenetic response

Dermatofibrosarcoma Protuberans
Indicated for adults with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans
400 mg PO q12hr

Mastocytosis
Indicated for adults with aggressive systemic mastocytosis without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown
Without D816V c-Kit mutation: 100 mg PO qDay
c-Kit mutational status unknown: 400 mg PO qDay if not responding to other therapies
ASM associated with eosinophilia (a clonal hematological disease related to the fusion kinase FIP1L1-PDGFR-alpha): 100 mg PO qDay initially, may increase to 400 mg/day in absence of adverse effects if response to therapy is insufficient

Gastrointestinal Stromal Tumors
Unresectable and/or metastatic malignant GIST
400 mg PO qDay; may increase to 400 mg BID in patients showing clear signs or symptoms of disease progression at a lower dose and in the absence of severe adverse drug reactions

Adjuvant treatment following complete gross resection of GIST
400 mg PO qDay x3 years

Hepatic impairment: Severe: Reduce dose by 25%.