Simponi Description

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 one strength: 50 mg of golimumab in 0.5 mL.
Each 50 mg single-use autoinjector contains 50 mg golimumab per 0.5 mL in an autoinjector.
SIMPONI is supplied as a single-use sterile solution in a Type 1 glass syringe with a fixed stainless steel needle. The syringe is contained in a single-use autoinjector. The syringe is stoppered with a coated stopper and the needle is covered with a needle shield to prevent leakage of the solution through the needle and to protect the needle during handling prior to administration. The fixed needle is a 5-bevel, 27G, half-inch stainless steel needle. The needle shields are manufactured using a dry natural rubber containing latex (see Immune: Allergic Reactions: Hypersensitivity Reactions: Latex Sensitivity under Precautions). SIMPONI does not contain preservatives.
SIMPONI (golimumab) is a human IgG1κ monoclonal antibody that exhibits multiple glycoforms with predicted molecular masses ranging from 149,802 daltons to 151,064 daltons. SIMPONI (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. Golimumab forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF, which prevents the binding of TNF to its receptors. Golimumab does not bind or neutralize human lymphotoxin. Golimumab inhibits TNF-induced activation of human endothelial cells and human diploid fibroblasts, and significantly reduces clinical symptoms and joint degradation in a human TNF transgenic mouse model of arthritis.
Summary Product Information: See Table 1.

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