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Each 100 mg Pre-filled pen contains 100 mg of guselkumab per 1 mL.
Guselkumab is a fully human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody (mAb) that binds selectively to the extracellular human interleukin 23 (IL-23) protein with high specificity and affinity. Guselkumab is produced in a mammalian cell line using recombinant DNA technology. Guselkumab is produced by a recombinant cell line of hamster origin using fed batch cell culture, and it is purified by a series of steps that includes measures to inactivate and remove viruses. No adjuvants are used.
Guselkumab (Tremfya) is essentially free of visible particulate material with a pH of approximately 5.8.
Guselkumab (Tremfya) does not contain preservatives.
Excipients/Inactive Ingredients: The excipients are L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, Sucrose and Water for injection.
