KYMRIAH Dispersion for infusion Ref.[8681] Active ingredients: Tisagenlecleucel

Kymriah (tisagenlecleucel) is a genetically modified autologous cell-based product containing T cells transduced ex vivo using a lentiviral vector expressing an anti-CD19 chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked via a human CD8 hinge and transmembrane region to an intracellular signalling chain of human 4-1BB (CD137) co-stimulatory domain and CD3-zeta signalling domain.

Each patient-specific infusion bag of Kymriah contains tisagenlecleucel at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 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 1.2 × 10⁶ to 6 × 10⁸ CAR-positive viable T cells in a cryopreservative-solution.

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.

Each infusion bag contains 10–30 mL or 30–50 mL of cell dispersion.

The quantitative information of medicinal product, including the number of infusion bags (see section 6) to be administered, is presented on the batch specific documentation accompanying the medicinal product for treatment.

Excipients with known effect

This medicinal product contains 2.43 mg sodium per mL and 24.3 to 121.5 mg sodium per dose. Each bag contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL.

For the full list of excipients, see section 6.1.