golimumab

FDA Drug Profile — Simponi, SIMPONI ARIA

Drug Details

Generic Name
golimumab
Brand Names
Simponi, SIMPONI ARIA
Application Number
BLA125289
Sponsor
Janssen Pharmaceutical Sciences Unlimited Company
NDC Codes
4
Dosage Forms
SOLUTION, INJECTION, SOLUTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
GOLIMUMAB

Indications and Usage

1 INDICATIONS AND USAGE SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate ( 1.1 ) adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2 ) adult patients with active ankylosing spondylitis (AS) ( 1.3 ) adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC) ( 1.4 ) 1.1 Rheumatoid Arthritis SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.2 Psoriatic Arthritis SIMPONI, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis. 1.3 Ankylosing Spondylitis SIMPONI is indicated for the treatment of adult patients with active ankylosing spondylitis. 1.4 Ulcerative Colitis SIMPONI is indicated for the treatment of adults and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis .