Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Kymriah 1.2 × 106 – 6 × 108 cells dispersion for infusion.
| Pharmaceutical Form |
|---|
|
Dispersion for infusion. A colourless to slightly yellow dispersion. |
Kymriah is an immunocellular therapy containing tisagenlecleucel, autologous T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
Each ethylene vinyl acetate (EVA) infusion bag of Kymriah contains tisagenlecleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells) (see section 4.2).
The concentration of CAR-positive viable T cells is dependent on indication and patient body weight (for B-cell acute lymphoblastic leukaemia [ALL]). The cellular composition and the final cell number varies between individual patient batches. In addition to T cells, NK cells may be present. The quantitative information regarding CAR-positive viable T cells/mL and total cells in the product is presented in the batch-specific documentation accompanying Kymriah.
1-3 infusion bags containing a total of 1.2 × 10 6 to 6 × 10 8 CAR-positive viable T cells.
Excipient with known effect: This medicinal product contains 2.43 mg sodium per mL and 24.3 to 121.5 mg sodium per dose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tisagenlecleucel |
Tisagenlecleucel is an autologous, immunocellular cancer therapy which involves reprogramming a patient’s own T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19 expressing cells. |
| List of Excipients |
|---|
|
Glucose |
Ethylene vinyl acetate (EVA) infusion bag with polyvinyl chloride (PVC) tubing and a luer spike interconnector closed by a luer-lock cap containing either 10–30 mL (50 mL bags) or 30–50 mL (250 mL bags) cell dispersion.
Each infusion bag is placed into an aluminum cassette, then put in a plastic overwrap bag with absorbent sheets and sealed in a protective envelope (Tyvek).
One individual treatment dose comprises 1 to 3 infusion bags.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/18/1297/001
| Drug | Countries | |
|---|---|---|
| KYMRIAH | Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom |
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