YESCARTA Dispersion for infusion Ref.[8759] Active ingredients: Axicabtagene ciloleucel

Yescarta (axicabtagene ciloleucel) is a genetically modified autologous cell-based product containing T cells transduced ex vivo using a retroviral vector expressing an anti-CD19 chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (ScFv) linked to CD28 co-stimulatory domain and CD3-zeta signalling domain.

Each patient-specific infusion bag of Yescarta contains axicabtagene ciloleucel 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 infusion bag overall containing a cell dispersion for infusion of a target dose of 2 × 10⁶ anti-CD19 CAR-positive viable T cells per kg of body weight (range: 1 × 10⁶ – 2 × 10⁶ cells/kg), with a maximum of 2 × 10⁸ anti-CD19 CAR-positive viable T cells suspended in a cryopreservative solution.

Each infusion bag contains approximately 68 mL of dispersion for infusion.

<θ>Excipients with known effect: Each infusion bag of Yescarta contains 300 mg sodium and 3.4 mL of dimethyl sulfoxide (DMSO). Yescarta may contain residual amounts of gentamicin.

For the full list of excipients, see section 6.1.