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  • FDA Date: 11/21/2016

    Xultophy 100/3.6  (insulin degludec and liraglutide), injection
    REMS

    Goal of the Xultophy 100/3.6 (insulin degludec and liraglutide) injection REMS Program

    The goal of the XULTOPHY 100/3.6 REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with XULTOPHY 100/3.6 by:

      • Informing healthcare providers about the potential risk of medullary thyroid carcinoma associated with XULTOPHY 100/3.6.

      • Informing healthcare providers about the risk of acute pancreatitis (including necrotizing pancreatitis) associated with XULTOPHY 100/3.6.

    REMS Elements

    • Communication Plan