Tocilizumab-aazg

FDA Drug Profile — TYENNE

Drug Details

Generic Name
Tocilizumab-aazg
Brand Names
TYENNE
Application Number
BLA761275
Sponsor
Fresenius Kabi USA, LLC
NDC Codes
7
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE, INJECTION, SOLUTION
Routes
INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
TOCILIZUMAB

Indications and Usage

1 INDICATIONS AND USAGE TYENNE ® (tocilizumab-aazg) 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. 1.1 Rheumatoid Arthritis (RA) TYENNE ® (tocilizumab-aazg) 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) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. 1.3 Polyarticular Juvenile Idiopathic Arthritis (PJIA) TYENNE ® (tocilizumab-aazg) 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) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.