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IMJUDO (tremelimumab) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, in a single-dose vial for intravenous infusion after dilution. IMJUDO contains tremelimumab at a concentration of 20 mg/mL in either a 25 mg/1.25 mL or a 300 mg/15 mL single-dose vial.
Each mL contains 20 mg of tremelimumab.
Tremelimumab, a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking human IgG2 monoclonal antibody, is produced by recombinant DNA technology in NS0 cell suspension culture and has a molecular weight of 149 kDa.
The pH is approximately 5.5.
Excipients/Inactive Ingredients: Edetate disodium (0.09 mg), histidine (0.68 mg), L-histidine hydrochloride monohydrate (3.3 mg), polysorbate 80 (0.2 mg), trehalose (76 mg), and Water for Injection, USP.
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