Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Abecma 260 – 500 × 106 cells dispersion for infusion.
| Pharmaceutical Form |
|---|
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Dispersion for infusion. A colourless dispersion. |
Abecma (idecabtagene vicleucel) is a genetically modified autologous immunotherapy consisting of human T cells transduced with lentiviral vector (LVV) encoding a chimeric antigen receptor (CAR) that recognises B-cell maturation antigen.
Each patient-specific infusion bag of Abecma contains idecabtagene vicleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-BCMA chimeric antigen receptor (CAR-positive viable T cells). The finished product is packaged in one or more infusion bags containing a cell dispersion of 260 to 500 × 106 CAR-positive viable T cells.
Each infusion bag contains 10-30 mL, 30-70 mL or 55-100 mL of dispersion for infusion.
The cellular composition and the final cell number varies between individual patient batches. In addition to T cells, natural killer (NK) cells may be present. The quantitative information regarding the number of CAR-positive viable T cells/bag are presented in the release for infusion certificate (RfIC) documentation located inside the lid of the dry vapour shipper used for transport.
Excipients with known effect: This medicinal product contains 5% dimethyl sulfoxide (DMSO), up to 752 mg sodium and up to 274 mg potassium per dose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Idecabtagene vicleucel |
Idecabtagene vicleucel is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. Antigen-specific activation of idecabtagene vicleucel results in CAR-positive T cell proliferation, cytokine secretion and subsequent cytolytic killing of BCMA-expressing cells. |
| List of Excipients |
|---|
|
CryoStor CS10 |
Ethylene vinyl acetate cryopreservation bag(s) with sealed addition tube containing 10-30 mL (50 mL bag), 30-70 mL (250 mL bag) or 55-100 mL (500 mL bag) of cell dispersion.
Each cryopreservation bag is individually packed in a metal cassette.
One individual treatment dose is comprised of one or more infusion bags of the same size and fill volume.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/21/1539/001
Date of first authorisation: 18 August 2021
| Drug | Countries | |
|---|---|---|
| ABECMA | Austria, Canada, Cyprus, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United States |
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