TAFACITAMAB 200 MG INJECTION
Tafasitamab-cxix is a humanized CD19-directed cytolytic monoclonal antibody that contains an IgG1/2 hybrid Fc-domain with 2 amino acid substitutions to modify the Fc-mediated functions of the antibody. It is produced by recombinant DNA technology in mammalian cells (Chinese hamster ovary). Tafasitamab-cxix has a molecular weight of approximately 150 kDa. MONJUVI (tafasitamab-cxix) for injection is supplied as a sterile, preservative-free, white to slightly yellowish lyophilized powder in a single-dose vial for intravenous use after reconstitution and further dilution. After reconstitution with 5 mL of Sterile Water for Injection, USP, the resulting concentration is 40 mg/mL with a pH of 6.0. Each single-dose vial contains 200 mg tafasitamab-cxix, citric acid monohydrate (3.7 mg), polysorbate 20 (1 mg), sodium citrate dihydrate (31.6 mg) and trehalose dihydrate (378.3 mg).
200 mg of tafasitamab-cxix as lyophilized powder in single dose vial
As per Recommendation by Company:
The recommended dosage of MONJUVI is 12 mg/kg as an intravenous
infusion according to the following dosing schedule: (2.1)
*Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle.
* Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle.
*Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle
MONJUVI is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
