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FDA Date: 7/12/17
Blincyto (blinatumomab) REMS
Goals of the Blincyto (blinatumomab) REMS Program
The goals of the BLINCYTO REMS is to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe, life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
• Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
• Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
• Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated with use of BLINCYTO.
• Communication Plan