Blinatumomab

Therapeutic Blinatumomab antibody from the original Blincyto® commercial drug.

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Antigen
Molecular Class
Drug Brand
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CoA
Quantity per vial
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Expiry Date
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CD19
,
CD3
Bi-specific T-cell engager
Blincyto®
0,0125 mg/mL
0,002 mg
2-8°C/-80°C
12/2024
945,00 
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Blincyto® / Blinatumomab Reference Product

Drug nameBlyncito®
INNBlinatumomab
API typeBlinatumomab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Pharmacotherapeutic group
Antineoplastic agents, other Antineoplastic agents
ATC code
L01XC19
Target of antibody
CD19, CD3
General functionBlinatumomab is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome
positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.
Blinatumomab is indicated as monotherapy for the treatment of adults and patients aged 1 year or older with Philadelphia chromosome
negative CD19 positive B-precursor.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
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. Blinatumomab is associated with transient upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T-cells, and results in elimination of CD19+ cells.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Consistent immune-pharmacodynamic responses were observed in patients studied. During the continuous intravenous infusion over 4 weeks, the pharmacodynamic response was characterised by T-cell activation and initial redistribution, rapid peripheral B-cell depletion, and transient cytokine elevation.
Original license holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Marketing authorisation numbers
EU/1/15/1047/001
Marketing authorisation holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Name of the manufacturer of the biological active substance
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Name and address of the manufacturer(s) responsible for batch releaseAmgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
Max shelf life
5 years
Storage conditions
2°C – 8°C
List of excipients
Citric acid monohydrate (E330)
Trehalose dihydrate
Lysine hydrochloride
Polysorbate 80
Sodium hydroxide (for pH-adjustment)
Evidentic Support
+49 (0) 30 959 99 8831

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