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.