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Each 100 mg Prefilled syringe 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.
TREMFYA is a clear, colorless to light yellow solution for subcutaneous injection.
The formulation is composed of 100 mg/mL TREMFYA, containing L-Histidine, L-Histidine monohydrochloride monohydrate, sucrose, polysorbate 80 and water for injection. Each mL of TREMFYA contains 100 mg of guselkumab, 0.6 mg L-histidine and 1.5 mg L-histidine monohydrochloride monohydrate, 79 mg sucrose, 0.5 mg polysorbate 80, and Water for Injection, USP.
TREMFYA is essentially free of visible particulate material with a pH of approximately 5.8.
TREMFYA does not contain preservatives.
Excipients/Inactive Ingredients: L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, Sucrose, Water for injection.
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