SIMPONI- golimumab injection, solution

JOM Pharmaceutical Services Inc.

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

Refrigerate SIMPONI at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Do not use SIMPONI beyond the expiration date (EXP) on the carton or the expiration date on the prefilled syringe (observed through the viewing window) or the prefilled SmartJect® autoinjector.

If needed, SIMPONI may be stored at room temperature up to 77°F (25°C) for a maximum single period of 30 days in the original carton to protect from light. Once a syringe or autoinjector has been stored at room temperature, do not return the product to the refrigerator. If not used within 30 days at room temperature, discard SIMPONI.