FDA Updates REMS and Black Box Warnings for Blinatumomab
![FDA Updates REMS and Black Box Warnings for Blinatumomab](/sites/default/files/2018-03/FDA-Update-700_11_6.jpg)
In May 2019, the U.S. Food and Drug Administration (FDA) added new clarifications to its risk evaluation and mitigation strategy (REMS) and black box warnings for blinatumomab (Blincyto®). Blinatumomab is a bispecific, CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with (a) B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% or (b) relapsed or refractory B-cell precursor ALL.
BOXED WARNING: Cytokine Release Syndrome (CRS)
- CRS, which may be life-threatening or fatal, occurred in patients receiving blinatumomab.
- Monitor patients for signs or symptoms of CRS.
- has been recently approved for the treatment of MRD-positive B-cell precursor ALL in adults and children.
- NEW: In patients treated for MRD-positive B-cell precursor ALL, hospitalization is recommended for the first three days of the first cycle and the first two days of the second cycle.
- In patients treated for relapsed or refractory B-cell precursor ALL, hospitalization is recommended for the first nine days of the first cycle and the first two days of the second cycle.
- NEW: Administer corticosteroids for severe or life-threatening CRS.
BOXED WARNING: Neurologic Toxicities
- In patients with ALL receiving BLINCYTO in clinical studies, neurological toxicities have occurred in approximately 65% of patients.
- NEW: Manifestations of neurological toxicity included cranial nerve disorders.
OTHER SERIOUS RISKS: Preparation and Administration Errors
- Instructions for preparation, including admixing, and administration must be strictly followed to minimize medication errors, including underdose and overdose.
For more detailed safety information, refer to the FDA-reviewed REMS Fact Sheet (http://click.hg-email.com/?qs=7a6493719ab12c8d4a285282da244d58e2ba47beca4c71e8e8cfdca90479e1849d99b64e9ea6fa025a642e53805d41f260301c8f65a9a852), the full prescribing information (https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/blincyto/blincyto_pi_hcp_english.pdf), and Amgen’s Blincyto REMS website (http://click.hg-email.com/?qs=7a6493719ab12c8d6ec66deea2b8fddaeeeb48d97c85d22e10e6dc4a42b192ca7af722008e8f8bfdfa6ff2cd6e88fab5bda2bf41487ac6f2).