TREMFYA Solution for injection Ref.[111726] Active ingredients: Guselkumab

Guselkumab, an interleukin-23 antagonist, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. Guselkumab is produced in a mammalian cell line using recombinant DNA technology and has an approximate molecular weight of approximately 147 kDa.

TREMFYA (guselkumab) injection is a sterile, preservative free, clear, and colorless to light yellow solution.

TREMFYA for Subcutaneous Injection

Available as a 100 mg/mL solution in a 1 mL or 2 mL glass prefilled syringe, in a 2 mL prefilled pen, or in a 1 mL One-Press patient-controlled injector for subcutaneous use.

Each TREMFYA 1 mL prefilled syringe or One-Press patient-controlled injector delivers 100 mg guselkumab, L-histidine (0.6 mg), L-histidine monohydrochloride monohydrate (1.5 mg), polysorbate 80 (0.5 mg), sucrose (79 mg) and water for injection at pH 5.8.

Each TREMFYA 2 mL prefilled syringe or prefilled pen (TREMFYA PEN) delivers 200 mg guselkumab, L-histidine (1.2 mg), L-histidine monohydrochloride monohydrate (3 mg), polysorbate 80 (1 mg), sucrose (158 mg) and water for injection at pH 5.8.

TREMFYA for Intravenous Infusion

Available as 10 mg/mL solution in a 20 mL single-dose vial for intravenous use.

Each TREMFYA 20 mL vial delivers 200 mg guselkumab, EDTA disodium dihydrate (0.4 mg), L-histidine (11.3 mg), L-histidine monohydrochloride monohydrate (26.6 mg), L-methionine (8 mg), polysorbate 80 (10 mg), sucrose (1700 mg) and water for injection at pH 5.8.