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BLINCYTO Powder for concentrate solution (2019)

Active ingredients: Blinatumomab

Product Name and Form

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.

Pharmaceutical form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
Blinatumomab

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.

List of excipients

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

Pack sizes and Marketing

Each BLINCYTO pack contains 1 vial of powder for concentrate for solution for infusion and 1 vial of solution (stabiliser):

  • 38.5 micrograms blinatumomab powder in a vial (type I glass) with a stopper (elastomeric rubber), seal (aluminium) and a flip off cap and
  • 10 mL solution in a vial (type I glass) with a stopper (elastomeric rubber), seal (aluminium) and a flip off cap.
Marketing authorization holder
Authorization dates

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Date of first authorisation: 23 November 2015
Date of last renewal: 19 April 2018

Marketing authorization number:

EU/1/15/1047/001