SPL Set ID: 12a75613-ee33-d30a-215b-2a51cfa19b00

Ustekinumab-kfce, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-kfce is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. YESINTEK (ustekinumab-kfce) injection is a sterile, preservative-free, clear and colorless to pale yellow solution with pH of 5.7- 6.3. YESINTEK for Subcutaneous Use Available as 45 mg of ustekinumab-kfce in 0.5 mL and 90 mg of ustekinumab-kfce 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-kfce in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-kfce, histidine, L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Hydrochloric acid and sodium hydroxide are used to adjust pH to 5.7- 6.3 during manufacturing. Each 1 mL prefilled syringe delivers 90 mg ustekinumab-kfce, histidine, L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). Hydrochloric acid and sodium hydroxide are used to adjust pH to 5.7- 6.3 during manufacturing. YESINTEK for Intravenous Infusion Available as 130 mg of ustekinumab-kfce in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-kfce, 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). Hydrochloric acid and sodium hydroxide added to adjust the pH to 5.7- 6.3 during manufacturing.