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Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons.
Etanercept is a TNF alpha inhibitor that binds specifically to tumor necrosis factor (TNF) and blocks its interaction with cell surface TNF receptors. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of RA patients. It plays an important role in the inflammatory processes of rheumatoid arthritis (RA), polyarticular-course juvenile rheumatoid arthritis (JRA) and the resulting joint pathology.
Etanercept is a tumor necrosis factor (TNF) blocker indicated for:
i. Adults with Rheumatoid Arthritis (RA): Etanercept indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Etanercept can be initiated in combination with methotrexate (MTX) or used alone for the treatment of active rheumatoid arthritis (RA) in adults when one or more disease modifying antirheumatic drugs (DMARDs), including methotrexate (unless contraindicated), has proved inadequate.
ii. Pediatric patients with Juvenile Idiopathic Arthritis (JIA): Etanercept indicated for the treatment of polyarticular-course juvenile idiopathic arthritis (JIA) in children and adolescents from the age of 2 years when the response to one or more DMARDs has proven inadequate.
iii. Adults with Psoriatic Arthritis (PsA): Etanercept is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Etanercept can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone.
iv. Adults with Ankylosing Spondylitis (AS): Etanercept is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).
v. Adults with Plaque Psoriasis (PsO): Etanercept is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
vi. Pediatric patients with Plaque Psoriasis (PsO): Etanercept is indicated for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years, who are inadequately controlled by or are intolerant to systemic therapies or phototherapies.
Etacept® 25 mg pre-filled syringe injection: Each box contains 1 pre-filled syringe containing 0.5 ml sterile solution of Etanercept INN 25 mg and an alcohol pad.
Etacept® 50 mg pre-filled syringe injection: Each box contains 1 pre-filled syringe containing 1 ml sterile solution of Etanercept INN 50 mg and an alcohol pad.