国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
tisagenlecleucel
Novartis Europharm Limited
L01XL04
tisagenlecleucel
Other antineoplastic agents
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Kymriah is indicated for the treatment of:• Paediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse.• Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy.• Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Revision: 14
Authorised
2018-08-22
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 × 10 6 – 6 × 10 8 cells dispersion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION 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. 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 × 10 6 to 6 × 10 8 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 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 × 10 6 – 6 × 10 8 cells dispersion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION 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. 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 × 10 6 to 6 × 10 8 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 完全なドキュメントを読む