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  • FDA Date: 05/16/2017

    Caprelsa (vandetanib) Tablets REMS

    Goals of the Caprelsa (vandetanib) Tablets REMS Program

    The goals of the CAPRELSA REMS Program are to mitigate the serious risks of QT prolongation, Torsades de pointes, and sudden death associated with use of CAPRELSA by:

    - Educating prescribers on the following:

      ° Serious risks of QT prolongation, Torsades de pointes, and sudden death associated with use of CAPRELSA.

      ° The need to monitor for QT prolongation and electrolyte abnormalities.

      ° Appropriate management of QT prolongation to minimize the occurrence of Torsades de pointes and sudden death associated with use of CAPRELSA.

    - Informing patients on the following:

    ° Serious risks of QT prolongation, Torsades de pointes, and sudden death associated with use of CAPRELSA

    REMS Elements

    • Elements to Assure Safe Use

    • Implementation System