BLINATUMOMAB 35 MCG INJECTION
BLINCYTO (blinatumomab) is a bispecific CD19-directed1 CD3 T-cell engager that binds to CD19 (expressed on cells of B-lineage origin) and CD3 (expressed on T cells). BLINCYTO is produced in Chinese hamster ovary cells. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons. Each BLINCYTO package contains 1 vial BLINCYTO and 1 vial IV Solution Stabilizer. BLINCYTO is supplied in a single-dose vial as a sterile, preservative-free, white to off-white lyophilized powder for intravenous administration. Each single-dose vial of BLINCYTO contains 35 mcg blinatumomab, citric acid monohydrate (3.35 mg), lysine hydrochloride (23.23 mg), polysorbate 80 (0.64 mg), trehalose dihydrate (95.5 mg), and sodium hydroxide to adjust pH to 7.0. After reconstitution with 3 mL of preservative-free Sterile Water for Injection, USP, the resulting concentration is 12.5 mcg/mL blinatumomab
BLINCYTO (blinatumomab) injection: 35 mcg of lyophilized powder in a single-dose vial for reconstitution.
Please click here- https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf
"BLINCYTO (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with:
• 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%. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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