** Actemra (Tocilizumab) 200 mg/10 ml (20 mg/ml) 1 vial of 10 ml of concentrate for solution for infusion.
** For i.v. use after dilution.
** 1 vial contains:
200 mg tocilizumab, polysorbate 80, sucrose, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dehydrate and water for injections.
** Indications:
Rheumatoid arthritis; juvenile idiopathic arthritis; Castleman’s disease.
– Rheumatoid Arthritis (RA):
ACTEMRA® (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
– Polyarticular Juvenile Idiopathic Arthritis (PJIA):
ACTEMRA® (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
– Systemic Juvenile Idiopathic Arthritis (SJIA):
ACTEMRA® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
** Pharmacotherapeutic group:
Immunosupressants, Interleukin inhibitors; ATC code: L04AC07.
** Mechanism of Action
Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.
** Medicine: keep out of reach of children.
** Dosage and administration: see package insert.
** Store between 2 – 8 degrees C, do not freeze.
Keep the container in the outer carton in order to protect from light.
** Made for: F. Hoffmann-La Roche Ltd, Basel – Switzerland
by: Chugai Pharma Manufacturing Co., Ltd., Utsunomiya-city – Japan
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