tocilizumab

FDA Drug Profile — Tocilizumab-anoh, ACTEMRA, AVTOZMA, Actemra ACTPen, Actemra

Drug Details

Generic Name
tocilizumab
Brand Names
Tocilizumab-anoh, ACTEMRA, AVTOZMA, Actemra ACTPen, Actemra
Application Number
BLA761420
Sponsor
CELLTRION USA, Inc.
NDC Codes
16
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE, INJECTION, SOLUTION, LIQUID
Routes
INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
TOCILIZUMAB

Indications and Usage

1 INDICATIONS AND USAGE Tocilizumab-anoh is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) 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). Giant Cell Arteritis (GCA) ( 1.2 ) Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.3 ) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.4 ) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release Syndrome (CRS) ( 1.5 ) Adults and pediatric patients with 2 years of age and older with chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome. Coronavirus Disease 2019 (COVID-19) ( 1.6 ) Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 1.1 Rheumatoid Arthritis (RA) Tocilizumab-anoh 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). 1.2 Giant Cell Arteritis (GCA) Tocilizumab-anoh is indicated for the treatment of giant cell arteritis (GCA) in adult patients. 1.3 Polyarticular Juvenile Idiopathic Arthritis (PJIA) Tocilizumab-anoh is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. 1.4 Systemic Juvenile Idiopathic Arthritis (SJIA) Tocilizumab-anoh is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. 1.5 Cytokine Release Syndrome (CRS) Tocilizumab-anoh is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. 1.6 Coronavirus Disease 2019 (COVID-19) Tocilizumab-anoh is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non- invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).