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Tocilizumab

Generic Name
Tocilizumab
Brand Names
Actemra, RoActemra, Tyenne, Tofidence, Avtozma
Drug Type
Biotech
CAS Number
375823-41-9
Unique Ingredient Identifier
I031V2H011

Overview

Tocilizumab is a recombinant humanized monoclonal antibody IL-6 receptor inhibitor used to treat inflammatory and autoimmune conditions. It was first described in the literature in 2003 when Chugai, a subsidiary of Roche began developing IL-6 inhibiting monoclonal antibodies. Tocilizumab was granted FDA approval on 8 January 2010 to treat a number of inflammatory and autoimmune disorders, such as different types of arthritis and cytokine release syndrome. It was later approved by Health Canada on 30 April 2010. After being investigated to treat severely ill patients with COVID-19, tocilizumab was approved by the European Commission in December 2021 to treat COVID-19 in adults receiving systemic corticosteroids and supplemental oxygen or mechanical ventilation. Subsequently, it was granted approval by Health Canada and the FDA in October and December 2022, respectively. Tocilizumab-bavi, a biosimilar drug, was approved by the FDA in September 2023.

Background

Tocilizumab is a recombinant humanized monoclonal antibody IL-6 receptor inhibitor used to treat inflammatory and autoimmune conditions. It was first described in the literature in 2003 when Chugai, a subsidiary of Roche began developing IL-6 inhibiting monoclonal antibodies. Tocilizumab was granted FDA approval on 8 January 2010 to treat a number of inflammatory and autoimmune disorders, such as different types of arthritis and cytokine release syndrome. It was later approved by Health Canada on 30 April 2010. After being investigated to treat severely ill patients with COVID-19, tocilizumab was approved by the European Commission in December 2021 to treat COVID-19 in adults receiving systemic corticosteroids and supplemental oxygen or mechanical ventilation. Subsequently, it was granted approval by Health Canada and the FDA in October and December 2022, respectively. Tocilizumab-bavi, a biosimilar drug, was approved by the FDA in September 2023.

Indication

Tocilizumab is indicated to treat moderate to severe rheumatoid arthritis, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. Tocilizumab is also used to treat coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Associated Conditions

  • Coronavirus Disease 2019 (COVID‑19)
  • Cytokine Release Syndrome caused by CAR-T Cell Therapy
  • Giant Cell Arteritis (GCA)
  • Juvenile Chronic Polyarthritis
  • Moderate to Severe Rheumatoid Arthritis
  • Moderately to Severely Active Rheumatoid Arthritis
  • Polyarticular Juvenile Idiopathic Arthritis
  • Systemic Juvenile Idiopathic Arthritis (SJIA)
  • Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
  • Active systemic Juvenile idiopathic arthritis
  • Severe, active Rheumatoid arthritis

FDA Approved Products

ACTEMRA
Manufacturer:Genentech, Inc.
Route:INTRAVENOUS
Strength:200 mg in 10 mL
Approved: 2022/12/23
NDC:50242-136
Actemra ACTPen
Manufacturer:Genentech, Inc.
Route:SUBCUTANEOUS
Strength:162 mg in 0.9 mL
Approved: 2022/12/23
NDC:50242-143
Actemra
Manufacturer:Genentech, Inc.
Route:SUBCUTANEOUS
Strength:162 mg in 0.9 mL
Approved: 2022/12/23
NDC:50242-138
ACTEMRA
Manufacturer:Genentech, Inc.
Route:INTRAVENOUS
Strength:400 mg in 20 mL
Approved: 2022/12/23
NDC:50242-137
ACTEMRA
Manufacturer:Genentech, Inc.
Route:INTRAVENOUS
Strength:80 mg in 4 mL
Approved: 2022/12/23
NDC:50242-135

Singapore Approved Products

Actemra 162mg Solution for Injection in Pre-filled Syringe 162mg/0.9ml
Manufacturer:Vetter Pharma-Fertigung GmbH & Co KG
Form:INJECTION, SOLUTION
Strength:162 mg/0.9 mL
Online:Yes
Approved: 2015/08/28
Approval:SIN14837P
Actemra Concentrate for Solution for Infusion 20mg/ml
Manufacturer:Chugai Pharma Manufacturing Co., Ltd
Form:INFUSION, SOLUTION CONCENTRATE
Strength:20mg/ml
Online:Yes
Approved: 2009/11/03
Approval:SIN13723P

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