IMATINIB / KRKA

Film-coated tablets

100mg & 400 mg

Imatinib Krka d.d. is indicated for the treatment of

• adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
• adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
• adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
• adult patients with relapsed or refractory Ph+ ALL as monotherapy.
• adult patients with myelodysplastic/ myeloproliferative diseases (MDS/ MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements.
• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
• the treatment of adult patients with Kit (CD 117) positive unresectable and/ or metastatic malignant gastrointestinal stromal tumours (GIST).
• the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
  Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
• the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.