SPL Set ID: a6d75316-c9a7-49cf-83be-b7b6c6cecf7a

Ustekinumab-aauz, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-aauz is produced in a Chinese hamster ovary (CHO) cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-aauz is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. Ustekinumab-aauz injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly brown-yellow solution with pH of 5.7- 6.3. Ustekinumab-aauz for Subcutaneous Use Available as 45 mg of ustekinumab-aauz in 0.5 mL and 90 mg of ustekinumab-aauz in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose 3 mL Type I glass with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that is not made with natural rubber (latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-aauz, histidine (0.512 mg), Polysorbate 80 (0.02 mg), sucrose (38 mg) and hydrochloric acid (to adjust pH). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-aauz, histidine (1.024 mg), Polysorbate 80 (0.04 mg), sucrose (76 mg) and hydrochloric acid (to adjust pH). Ustekinumab-aauz for Intravenous Infusion Available as 130 mg of ustekinumab-aauz 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-aauz, edetate disodium (0.47 mg), histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg) and sucrose (2210 mg).