Stelara Description

Solution for Injection for Subcutaneous Administration (Pre-filled Syringe/Vial): Each mL of STELARA contains 90 mg of ustekinumab, 1.0 mg L histidine and L histidine hydrochloride, 76 mg sucrose, 0.04 mg polysorbate 80, and Water for Injection, USP. STELARA does not contain preservatives.
The solution is clear to slightly opalescent, colorless to light yellow with a pH of approximately 6.0.
Concentrate for Solution for Intravenous Infusion (Single-use Vial): Each mL of STELARA contains 5.0 mg of ustekinumab, 0.8 mg L-histidine, 1.1 mg L-histidine hydrochloride monohydrate, 85 mg sucrose, 0.40 mg polysorbate 80, 0.40 mg L-methionine, and 0.02 mg EDTA disodium salt dihydrate. STELARA does not contain preservatives.
The solution is clear, colorless to light yellow with a pH of approximately 6.0.
Ustekinumab is a fully human IgG1κ monoclonal antibody with an approximate molecular weight of 148600 daltons. Ustekinumab is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.
Excipients/Inactive Ingredients: Solution for Injection for Subcutaneous Administration (Pre-filled Syringe/Vial): L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, Sucrose, Water for injection.
Concentrate for Solution for Intravenous Infusion (Single-use Vial): EDTA disodium salt dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80, Sucrose, Water for injection.