Ustekinumab-stbadrug info

11. DESCRIPTION Ustekinumab-stba, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-stba is produced in a Chinese Hamster Ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-stba is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. STEQEYMA (ustekinumab-stba) injection is a sterile, preservative-free, clear to very slightly opalescent, and colorless to pale yellow solution with pH of 5.7. STEQEYMA for Subcutaneous Use Available as 45 mg of ustekinumab-stba in 0.5 mL and 90 mg of ustekinumab-stba in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-stba in 0.5 mL in a single-dose vial with a rubber stopper. The syringe is fitted with a needle safety guard and a needle cover. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-stba, histidine (0.18 mg), L-histidine monohydrochloride monohydrate (0.46 mg), polysorbate 80 (0.02 mg), sucrose (38 mg), and Water for Injection. Each 1 mL prefilled syringe delivers 90 mg ustekinumab-stba, histidine (0.36 mg), L-histidine monohydrochloride monohydrate (0.91 mg), polysorbate 80 (0.04 mg), sucrose (76 mg), and Water for Injection. STEQEYMA for Intravenous Infusion Available as 130 mg of ustekinumab-stba in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-stba, edetate disodium (0.47 mg), histidine (9.36 mg), L-histidine monohydrochloride monohydrate (23.66 mg), methionine (10.56 mg), polysorbate 80 (10.37 mg), sucrose (1,976 mg), and Water for Injection.