(Approval lapsed) ORENCIA 125 mg solution for injection in pre-filled pen (Germany)

ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying antirheumatic drugs (DMARDs), such as methotrexate or tumour necrosis factor (TNF) blocking agents. A reduction in the progression of joint damage and improvement in physical function have been demonstrated during combination treatment with ORENCIA and methotrexate.

ORENCIA in combination with methotrexate is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis who have had an inadequate response to one or more diseasemodifying antirheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). (There is no clinical trial data for the use of ORENCIA subcutaneous formulation in children, therefore its use in children cannot be recommended.)

ORENCIA is indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous diseasemodifying antirheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without nonbiologic DMARDs.

ORENCIA should not be administered concurrently with other biological DMARDs (e.g. TNF inhibitors,rituximab, or anakinra).