Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
| Pharmaceutical Form |
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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.
| Active Ingredient | Description | |
|---|---|---|
| Blinatumomab |
Blinatumomab is a bispecific T-cell engager molecule 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. The anti-tumour activity of blinatumomab immunotherapy is not dependent on T-cells bearing a specific TCR or on peptide antigens presented by cancer cells, but is polyclonal in nature and independent of human leukocyte antigen (HLA) molecules on target 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. |
| List of Excipients |
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Powder: Citric acid monohydrate (E330) Solution (stabiliser): Citric acid monohydrate (E330) |
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: 9 March 2023
| Drug | Countries | |
|---|---|---|
| BLINCYTO | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa |
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