FDA Updates REMS and Black Box Warnings for Blinatumomab
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).