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  • FDA Date: 11/28/2016

    Iclusig (ponatinib) Tablets REMS

    Goals of the Iclusig (ponatinib) Tablets REMS Program

    The goals of the Iclusig REMS are to:

    Inform prescribers of the indications for Iclusig which are limited to:

    • Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia  chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated

    • Treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL
       Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.

    Inform prescribers of the risks of arterial occlusion and venous thromboembolism associated with Iclusig treatment

    REMS Elements

    • Communication Plan