Simponi Description

SIMPONI is available as a solution for injection for subcutaneous administration in the following presentations: Autoinjector/pre-filled pen: Each 50mg single-use autoinjector/pre-filled pen contains 50 mg golimumab per 0.5 mL in an autoinjector/pre-filled pen.
Each 100mg single-use autoinjector/pre-filled pen contains 100 mg golimumab per 1.0 mL in an autoinjector/pre-filled pen.
SIMPONI does not contain preservatives. The solution is clear to slightly opalescent, colorless to light yellow with a pH of approximately 5.5. Each mL of SIMPONI contains 100 mg of golimumab, 0.87 mg L-histidine and L-histidine hydrochloride, 41.0 mg sorbitol, 0.15 mg polysorbate 80, and Water for Injection. SIMPONI is available in two strengths: 50 mg of golimumab in 0.5 mL and 100 mg of golimumab in 1 mL.
SIMPONI is available as a solution for intravenous (IV) infusion: Single-use vial: Each single-use vial contains 50 mg golimumab per 4 mL vial (or 12.5 mg of golimumab per mL).
SIMPONI does not contain preservatives. The solution is colorless to light yellow with a pH of approximately 5.5. Each 4 mL vial of SIMPONI contains 50 mg golimumab, 1.14 mg L-histidine and 6.42 mg L-histidine monohydrochloride monohydrate, 180 mg sorbitol, 0.6 mg polysorbate 80, and Water for Injection.
Golimumab is a human IgG1κ monoclonal antibody that exhibits multiple glycoforms with predicted molecular masses ranging from 149802 daltons to 151064 daltons. Golimumab 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: L-histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, Sorbitol, Water for injections.