Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
CARVYKTI 3.2 × 106 – 1.0 × 108 cells dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Dispersion for infusion. A colourless to white, including shades of white, yellow, and pink, dispersion. |
CARVYKTI (ciltacabtagene autoleucel) is a genetically modified autologous cell-based product, containing T cells transduced ex vivo using a replication incompetent lentiviral vector encoding an anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR), comprising two single domain antibodies linked to a 4-1BB costimulatory domain and a CD3-zeta signaling domain.
Each patient-specific infusion bag of CARVYKTI contains ciltacabtagene autoleucel at a batch-dependent concentration of autologous T cells genetically modified to express an anti-BCMA chimeric antigen receptor (CAR-positive viable T cells) (see section 4.2). The medicinal product is packaged in one infusion bag containing a cell dispersion for infusion of 3.2 × 106 to 1.0 × 108 CAR-positive viable T cells suspended in a cryopreservative solution.
An infusion bag contains 30 mL or 70 mL of dispersion for infusion.
The cellular composition and the final cell number is dependent on patient body weight and varies between individual patient batches. In addition to T cells, Natural Killer (NK) cells may be present.
The quantitative information of the medicinal product including the total viable cell concentration, volume of dispersion and total number of CAR+ cells per bag and supplied dose is presented in the Lot Information Sheet included with the cryo cassette used for transport of CARVYKTI.
Excipient(s) with known effect:
Each dose of CARVYKTI contains 0.05 mL of dimethyl sulfoxide (DMSO) per mL and residual kanamycin (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ciltacabtagene autoleucel |
Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T cell immunotherapy, which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. |
| List of Excipients |
|---|
|
Cryostor CS5 (contains dimethyl sulfoxide) |
Ethylene vinyl acetate (EVA) infusion bag with sealed addition tube and two available spike ports containing either 30 mL (50 mL bag) or 70 mL (250 mL bag) of cell dispersion. Each infusion bag is packed in an aluminium cryo cassette.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/22/1648/001
| Drug | Countries | |
|---|---|---|
| CARVYKTI | Canada, Estonia, France, Croatia, Lithuania, Romania, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
