Basic Information
ICLUSIG TABLET 15 MG
TABLET, FILM COATED
Regulatory Information
SIN15581P
November 19, 2018
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 4, 2025
XL01EA05
Company Information
Active Ingredients
Strength: 15 MG
Detailed Information
Contraindications
**4.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
Indication Information
**4.1 Therapeutic indications** 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. See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.