Source: European Medicines Agency (EU) Revision Year: 2024 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 |
|---|
|
Dispersion for infusion. A colourless dispersion. |
Abecma (idecabtagene vicleucel) is a genetically modified autologous cell-based product containing T cells transduced ex-vivo using a replication incompetent lentiviral vector (LVV) encoding a chimeric antigen receptor (CAR) that recognises B-cell maturation antigen (BCMA), comprising a murinederived, anti-human BCMA single chain variable fragment (scFv) linked to a 4-1BB costimulatory domain and a CD3-zeta signalling domain.
Each patient-specific infusion bag of Abecma contains idecabtagene vicleucel 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 medicinal product is packaged in one or more infusion bags overall containing a cell dispersion of 260 to 500 × 106 CAR-positive viable T cells suspended in a cryopreservative solution.
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 of medicinal product, including the number of infusion bag(s) to be administered, is presented in the release for infusion certificate (RfIC) located inside the lid of the cryoshipper 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 (contains dimethyl sulfoxide) |
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
Date of latest renewal: 08 June 2023
| Drug | Countries | |
|---|---|---|
| ABECMA | Austria, Canada, Cyprus, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United States |
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