All the Drug Class Drugs
Engineered Autologous T Cell Immunotherapy product. lisocabtagene maraleucel 1.1-70 x 10^6 cells/mL. Vial 1X 4.6 ml for IV inf.
For autologous use.
Tmt. consists of a sgle. dose containing a dispersion for inf. of CAR-positive viable T cells in one or more vials.
The target dose is 100 x 106 CAR-positive viable T cells (consisting of a target 1:1 ratio of CD4+ and CD8+ cell components) within a range of 44-120 x 106 CAR-positive viable T cells.
For adult pts. with large B-cell lymphoma (LBCL), incl. diffuse large B-cell lymphoma (DLBCL) not otherwise specified (incl. DLBCL arising from indolent lymphoma), high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have:
refractory dis. to first-line chemoimmunother. or relapse within 12 months of first-line chemoimmunother.; or
refractory dis. to first-line chemoimmunother. or relapse after first-line
chemoimmunother. and are not eligibale for hematopoetic stem cell transplant. (HSCT) due to comorbidities or age.
For adult pts. with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic ther.
C/I:Hypersens. Contraindic. of the lymphodepleting chemother. must be considered.
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.
Engineered Autologous T Cell Immunotherapy product. Axicabtagene Ciloleuce . BAG CRYOSTORE (Sol. for IV infus.):1. Dosage must be ajust. individ. See lit.
Tmt. of adult pts. with relapsed or refract. diffuse large B cell lymphoma. (DLBCL) and primary mediastin. large B cell lymphom. (PMBCL), after two or more lines of system. ther.
Limitation of Use: YESCARTA is not indicated for the tmt. of pts. with prim. or second. CNS lymphoma.
C/I: Hypersens.
Contraindications of the lymphodepleting chemother.must be considered.
