golimumab
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 .