LUMOXITI Powder for solution for injection Ref.[10359] Active ingredients:

Moxetumomab pasudotox-tdfk is a CD22-directed cytotoxin. Moxetumomab pasudotox-tdfk is composed of a recombinant, murine immunoglobulin variable domain genetically fused to a truncated form of Pseudomonas exotoxin, PE38, that inhibits protein synthesis. Moxetumomab pasudotox-tdfk has an approximate molecular weight of 63 kDa and is produced in E. coli cells by recombinant DNA technology. During the moxetumomab pasudotox-tdfk manufacturing process, fermentation is carried out in nutrient medium containing the antibiotic kanamycin. However, kanamycin is cleared in the manufacturing process and is not detectable in the final product.

LUMOXITI (moxetumomab pasudotox-tdfk) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized cake or powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. Each single-dose vial contains 1 mg moxetumomab pasudotox-tdfk, glycine (80 mg), polysorbate 80 (0.2 mg), sodium phosphate monobasic monohydrate (3.4 mg), sucrose (40 mg), and sodium hydroxide to adjust pH to 7.4. After reconstitution with 1.1 mL Sterile Water for Injection, USP, the resulting 1 mg/mL solution allows a withdrawal volume of 1 mL. Prior to intravenous infusion, the reconstituted vial(s) of solution are added to an infusion bag containing 50 mL of 0.9% Sodium Chloride Injection, USP and 1 mL of IV Solution Stabilizer.

IV Solution Stabilizer is a sterile, preservative-free, colorless to slightly yellow, clear solution free from visible particles and supplied in a single-dose vial. Each vial contains 1 mL solution. Each vial contains citric acid monohydrate (0.7 mg), polysorbate 80 (6.5 mg), sodium citrate dihydrate (6.4 mg), and Water for Injection, USP. The pH is 6.0.

The LUMOXITI and IV Solution Stabilizer vial stoppers are not made with natural rubber latex.