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Outline
What is the generic name?
GOLIMUMAB
What is the Trade Name for GOLIMUMAB?
Simponi
What are the Indications for GOLIMUMAB?
- 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 ) Active psoriatic arthritis (PsA) alone, or in combination with methotrexate ( 1.2 ) Active ankylosing spondylitis (AS) ( 1.3 ) Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy ( 1.4 ) inducing and maintaining clinical response improving endoscopic appearance of the mucosa during induction inducing clinical remission achieving and sustaining clinical remission in induction responders 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 in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for: inducing and maintaining clinical response improving endoscopic appearance of the mucosa during induction inducing clinical remission achieving and sustaining clinical remission in induction responders [see Clinical Studies (14.4) ].
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References: https://open.fda.gov/
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