FDA label
What is Simponi used for?
Simponi contains golimumab. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Simponi lists 4 uses: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Ulcerative Colitis.
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Simponi, injection, solution
Indications and Usage, quoted from the label by Janssen Biotech, Inc. (BLA125289). Cross-references to other label sections are left out.
Rheumatoid Arthritis
SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
Psoriatic Arthritis
SIMPONI, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis.
Ankylosing Spondylitis
SIMPONI is indicated for the treatment of adult patients with active ankylosing spondylitis.
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.
Source: DailyMed label, set id f86cb4a7-c358-4136-ae57-b32bda9bba00, version 43, effective September 17, 2026. NDC 57894-070, one of 2 listings for this product.
Questions
What is Simponi used for?
The FDA label for Simponi lists 4 uses: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Ulcerative Colitis.
What drug class is Simponi?
FDA lists golimumab in the Tumor Necrosis Factor Blocker established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.