Iclusig is a cancer medicine used to treat adults with the following types of leukaemia (cancer of white blood cells): · chronic myeloid leukaemia (CML) at any stage of the disease (chronic, accelerated or blast phase), when treatment with dasatinib or nilotinib (cancer medicines) has not worked, or when these medicines cannot be used because of side effects and imatinib (a cancer medicine) is not suitable, or when the cancer has a change in the BCR-ABL1 gene called T315I mutation; · acute lymphoblastic leukaemia (ALL) when the cancer is Philadelphia chromosome-positive (Ph+). Ph+ means that some of the patient’s genes have rearranged to form an abnormal chromosome that leads to the development of leukaemia. Iclusig is used when treatment with dasatinib has not worked, or when dasatinib cannot be used because of side effects and imatinib is not suitable, or when the cancer has a change in the BCR-ALB1 gene called T3151 mutation; · newly diagnosed acute lymphoblastic leukaemia when the cancer is Ph+. Iclusig is used together with reduced-intensity chemotherapy, which is less toxic than standard chemotherapy. Iclusig contains the active substance ponatinib.
Therapeutic Indication
### Therapeutic indication Iclusig is indicated in adult patients with - chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1). See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 situations where an alternative treatment may be considered.
Therapeutic Area (MeSH)
ATC Code
L01EA05
ATC Item
ponatinib
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
EMA Name
Iclusig
Medicine Name
Iclusig
Aliases
N/A
