|API type||humanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology
|Immunosuppressants, Interleukin inhibitors
|Target of antibody|
|IL-6 R; Synonyms: IL6R, il-6ra, CD126, IL-6R-1, IL-6RA, IL6Q, IL6RA, IL6RQ, gp80, IL6R1, Il6ra, IL-6Ralpha, IL6R, Il6r
(Mechanism of action; Source EMA document)
|Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R). Tocilizumab has been shown to inhibit sIL-6R and mIL-6R-mediated signalling. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, monocytes and fibroblasts. IL-6 is involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, induction of hepatic acute phase protein synthesis and stimulation of haemopoiesis. IL-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia.
|Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)||In clinical studies with tocilizumab, rapid decreases in CRP, erythrocyte sedimentation rate (ESR) and serum amyloid A (SAA) were observed. Consistent with the effect on acute phase reactants, treatment with tocilizumab was associated with reduction in platelet count within the normal range. Increases in haemoglobin levels were observed, through tocilizumab decreasing the IL-6 driven effects on hepcidin production to increase iron availability. In tocilizumab-treated patients, decreases in the levels of CRP to within normal ranges were seen as early as week 2, with decreases maintained while on treatment.
In healthy subjects administered tocilizumab in doses from 2 to 28 mg/kg, absolute neutrophil counts decreased to their lowest 3 to 5 days following administration. Thereafter, neutrophils recovered towards baseline in a dose dependent manner. Rheumatoid arthritis patients demonstrated a similar pattern of absolute neutrophil counts following tocilizumab administration (see section 4.8).
|Original license holder|
|Marketing authorisation numbers|
|EU/1/08/492/001 - 008
|Marketing authorisation holder|
|Roche Registration Limited
6 Falcon Way
Welwyn Garden City
|Name of the manufacturer of the biological active substance|
|Chugai Pharma Manufacturing Co., Ltd.
16-3 Kiyohara Kogyodanchi
One Antibody Way
|Name and address of the manufacturer(s) responsible for batch release||Roche Pharma AG
|Max shelf life|
|2°C – 8°C
|List of excipients|
Disodium phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Water for injections