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ORENCIA 250 mg powder for concentrate for solution for infusion.
Powder for concentrate for solution for infusion.
The powder is a white to off-white whole or fragmented cake.
Rheumatoid arthritis
ORENCIA, in combination with methotrexate, is indicated for:
• the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
• the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.
A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.
Polyarticular juvenile idiopathic arthritis
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor.
Based on its mechanism of action, abatacept is expected to have no or negligible influence on the ability to drive and use machines. However, dizziness and reduced visual acuity have been reported as common and uncommon adverse reactions respectively from patients treated with ORENCIA, therefore if a patient experiences such symptoms, driving and use of machinery should be avoided.
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