Tocilizumab

Therapeutic Tocilizumab antibody from the original RoActemra® commercial drug.

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Batch

Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
Quantity per vial
Storage Temperature
Expiry Date
Price
IL-6 receptor
Monoclonal Antibody
RoActemra®
20 mg/mL
2 mg
-80°C
10/2021
222,00 
view product
Max: 10
Min: 2
Step: 1
IL-6 receptor
Monoclonal Antibody
RoActemra®
20 mg/mL
2 mg
-80°C
05/2018
222,00 
view product
Max: 10
Min: 2
Step: 1
IL-6 receptor
Monoclonal Antibody
RoActemra®
20 mg/mL
2 mg
-80°C
03/2019
222,00 
view product
Max: 10
Min: 2
Step: 1
IL-6 receptor
Monoclonal Antibody
RoActemra®
20 mg/mL
2 mg
-80°C
05/2019
222,00 
view product
Max: 10
Min: 2
Step: 1
IL-6 receptor
Monoclonal Antibody
RoActemra®
20 mg/mL
2 mg
-80°C
03/2020
222,00 
view product
Max: 10
Min: 2
Step: 1

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RoActemra® / Tocilizumab Reference Product

Drug nameRoActemra®
INNTocilizumab
API typehumanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology
Pharmacotherapeutic group
Immunosuppressants, Interleukin inhibitors
ATC code
L04AC07
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
General functionTocilizumab is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not
previously treated with MTX and moderate to severe active RA in adult patients who have either responded
inadequately to, or who were intolerant to, previous therapy with one or more diseasemodifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
Short description
Pharmacodynamic properties
(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
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Name of the manufacturer of the biological active substance
Chugai Pharma Manufacturing Co., Ltd.
16-3 Kiyohara Kogyodanchi
Utsunomiya City
Tochigi, 321-3231
Japan

Genentech Inc.
One Antibody Way
Oceanside
CA 92056
USA
Name and address of the manufacturer(s) responsible for batch releaseRoche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany
Max shelf life
30 months
Storage conditions
2°C – 8°C
List of excipients
Sucrose
Polysorbate 80
Disodium phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Water for injections
Evidentic Support
+49 (0) 30 959 99 8831

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