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Simponi

Simponi Indications/Uses

golimumab

Manufacturer:

Johnson & Johnson

Distributor:

DKSH
/
Four Star
Full Prescribing Info
Indications/Uses
Rheumatoid Arthritis (RA): SIMPONI, in combination with methotrexate (MTX), is indicated for: Reducing signs and symptoms and improving physical function in adult patients with moderately to severely active rheumatoid arthritis; Inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who had not previously been treated with MTX.
Psoriatic Arthritis (PsA): SIMPONI is indicated for: Reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active psoriatic arthritis. SIMPONI can be used in combination with MTX in patients who do not respond adequately to MTX alone.
Ankylosing Spondylitis (AS): SIMPONI is indicated for: Reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapies.
Non-radiographic Axial Spondyloarthritis (nr-Ax SpA): SIMPONI is indicated for: The treatment of adults with severe active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ulcerative Colitis (UC): SIMPONI is indicated in adult patients with moderately to severely active disease who have had an inadequate response to, or have medical contraindications for, conventional therapy including corticosteroids, amino salicylates, azathioprine (AZA), or 6-mercaptopurine (6-MP), for: Inducing and maintaining clinical response (reduction in signs and symptoms); Inducing clinical remission; Achieving sustained clinical remission in induction responders; Improving endoscopic appearance of the mucosa during induction (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
Geriatrics (≥65 years of age): See Use in the Elderly under Precautions; and Pharmacology: Pharmacokinetics: Special Populations and Conditions: Geriatrics under Actions.
Pediatrics (<18 years of age): The safety and efficacy of SIMPONI have not been established in pediatric patients aged 17 years and younger.
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