Active ingredients: Blinatumomab
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Powder for concentrate and solution for solution for infusion.
BLINCYTO powder (powder for concentrate): White to off-white powder.
Solution (stabiliser): Colourless-to-slightly yellow, clear solution with a pH of 7.0.
One vial of powder contains 38.5 micrograms blinatumomab.
Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL.
Blinatumomab is produced in Chinese hamster ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
Blinatumomab is a bispecific T-cell engager antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T-cells. It activates endogenous T-cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B-cells. Blinatumomab mediates the formation of a cytolytic synapse between the T-cell and the tumour cell, releasing proteolytic enzymes to kill both proliferating and resting target cells.
Powder:
Citric acid monohydrate (E330)
Trehalose dihydrate
Lysine hydrochloride
Polysorbate 80
Sodium hydroxide (for pH-adjustment)
Solution (stabiliser):
Citric acid monohydrate (E330)
Lysine hydrochloride
Polysorbate 80
Sodium hydroxide (for pH-adjustment)
Water for injections
Each BLINCYTO pack contains 1 vial of powder for concentrate for solution for infusion and 1 vial of solution (stabiliser):
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
EU/1/15/1047/001
Date of first authorisation: 23 November 2015
Date of last renewal: 19 April 2018