(Approval lapsed) RoActemra tocilizumab 80mg/4mL concentrate for solution for infusion (Roche Germany)

Rheumatoid Arthritis:

Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs.

Tocilizumab is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors in combination with MTX in those not previously treated with MTX.

In the two groups of patients above, tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Tocilizumab has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate.

Polyarticular Juvenile Idiopathic Arthritis:

Tocilizumab is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). It can be given alone or in combination with MTX.

Systemic Juvenile Idiopathic Arthritis:

Tocilizumab is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

Cytokine Release Syndrome (CRS):

Tocilizumab is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.