All the Active Ingredient Drugs
Engineered Autologous T Cell Immunotherapy product. Tisagenlecleucel . Dispers. for IV inf. cont. 10-30 ml or 30-50 ml.
Dosage in paed. and young adlt. CD19+ B-cell ALL pts. - For pts. under 50 kg : 0.2 to 5 x 106 CAR-posit. viable T cells/kg BW. - For pts. above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T cells (non-weight based). Dosage in adlt. DLBCL and FL pts. - 0.6 to 6.0 x 108 CAR-posit. viable T cells (non-weight based).
Paed. and young adlt. pts. up to and incl. 25 years of age with CD19+ B-cell acute lymphoblastic leukaemia (ALL) refract., in relapse post-transpl. or in second or later relapse. – Adlt. pts. with relapsed or refract. diffuse large B-cell lymphoma (DLBCL) after two or more lines of syst. ther. Limit of Use: not for tmt. of pts. with prim. or second. CNS lymphoma- Adlt. pts. with relapsed or refract. follicular lymphoma (FL) after two or more lines of syst. ther.
C/I: Hypersens. Also consider C/I of the lymphodepleting chemother.
