Product Information

Description

SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: 1 Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ( 1.1) , 2 Active Psoriatic Arthritis (PsA) in patients 2 years of age and older ( 1.2) , 3 Adult patients with active Ankylosing Spondylitis (AS) ( 1.3) , 4 Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older ( 1.4) .

Golimumab is a human IgG1? monoclonal antibody specific for human tumor necrosis factor alpha (TNFa) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. Golimumab was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. 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. The SIMPONI ARIA ®(golimumab) Injection is a sterile solution of the golimumab antibody supplied in a 4-mL glass vial for intravenous infusion. SIMPONI ARIA is a preservative-free, colorless to light yellow solution with a pH of approximately 5.5. SIMPONI ARIA is not made with natural rubber latex. Each 4-mL vial of SIMPONI ARIA contains 50 mg golimumab, L-histidine (1.14 mg), L-histidine monohydrochloride monohydrate (6.42 mg), polysorbate 80 (0.6 mg), sorbitol (180 mg), and water for injection.