INDICATIONS AND USAGE（适应症）

Rheumatoid Arthritis (RA)

SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

Psoriatic Arthritis (PsA)

SIMPONI ARIA is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older.

Ankylosing Spondylitis (AS)

SIMPONI ARIA is indicated for the treatment of adult patients with active ankylosing spondylitis.

Polyarticular Juvenile Idiopathic Arthritis (pJIA)

SIMPONI ARIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

DOSAGE（服用剂量）

Dosage in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

The SIMPONI ARIA dosage regimen is 2 mg per kg given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. Follow the dilution and administration instructions for SIMPONI ARIA.

For patients with rheumatoid arthritis (RA), SIMPONI ARIA should be given in combination with methotrexate.

The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established.

Dosage in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis

The SIMPONI ARIA dosage regimen, based on body surface area (BSA), is 80 mg/m2 given as an intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter. Follow the dilution and administration instructions for SIMPONI ARIA.

ADVERSE REACTIONS（不良反应）

Serious Infections

Malignancies

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/9e260a47-55af-4c92-8d88-a86ccc767fff/spl-doc?hl=Simponi#S2.4

Simponiinformation