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Health Canada Approves SIMPONI(TM) (golimumab) for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Date:4/13/2009

rst once-monthly subcutaneous anti-TNF-alpha therapy, SIMPONI is approved in Canada for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, and is available either through the SIMPONI SmartJect auto injector or a prefilled syringe. SIMPONI is also being studied as an intravenous infusion therapy for the treatment of rheumatoid arthritis.

    In Canada, SIMPONI is approved for:
    -- In combination with methotrexate (MTX), reducing signs and symptoms in
       adult patients with moderately to severely active rheumatoid arthritis.
    -- Reducing signs and symptoms in adult patients with moderately to
       severely active psoriatic arthritis, alone or in combination with MTX.
       SIMPONI can be used in combination with MTX in patients who do not
       respond adequately to MTX alone.
    -- Reducing signs and symptoms in adult patients with active ankylosing
       spondylitis who have had an inadequate response to conventional
       therapies.

Important Safety Information

SIMPONI is contraindicated in patients with severe infections such as sepsis, tuberculosis and opportunistic infections and in patients who are hypersensitive to golimumab, latex or any of the excipients. Serious infections, including sepsis, pneumonia, tuberculosis, invasive fungal and other opportunistic infections have been observed with the use of TNF antagonists including SIMPONI. Some of these infections have been fatal. SIMPONI should not be given to patients with a clinically important, active infection (chronic or localized). Caution should be exercised when considering the use of SIMPONI in patients with a chronic infection or a history of recurrent infection. Patients should be monitored for signs and symptoms of infection while on or after treatment with SIMPONI. If a patient develops a serious infection or sepsis, SIMPONI the
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SOURCE Centocor Ortho Biotech Inc.; Schering-Plough Corporation
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