Biological activity of TNF is dependent upon binding to either cell surface TNFR.Įtanercept is a dimeric soluble form of the p75 TNFR that can bind to two TNF molecules. Two distinct receptors for TNF (TNFRs), a 55 kilodalton protein (p55) and a 75 kilodalton protein (p75), exist naturally as monomeric molecules on cell surfaces and in soluble forms. Elevated levels of TNF are found in the involved tissues and fluids of patients with RA, PsA, AS and plaque psoriasis. In addition, TNF plays a role in the inflammatory process of plaque psoriasis. It plays an important role in the inflammatory processes of rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), and the resulting joint pathology. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Pharmacology PharmacodynamicsĮtanercept binds specifically to the TNF and blocks its interaction with cell surface TNFRs. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. The Fc component of etanercept contains the C H2 domain, the C H3 domain and hinge region, but not the C H1 domain of IgG1. Lyophilized powder for solution for subcutaneous injection DescriptionĮtanercept is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) TNF-receptor (TNFR) linked to the Fc portion of human IgG1. (As a sterile lyophilized powder) Dosage Form Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumour necrosis factor (tnf)-blockers, including etanercept. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with etanercept, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. The risks and benefits of treatment with etanercept should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Bacterial, viral and other infections due to opportunistic pathogens, including legionella and listeria.Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis.Treatment for latent infection should be initiated prior to etanercept use. Patients should be tested for latent tuberculosis before etanercept use and during therapy. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease.
Active tuberculosis, including reactivation of latent tuberculosis.Reported infections include the following: Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate (MTX) or corticosteroids.Įtanercept should be discontinued if a patient develops a serious infection or sepsis. Patients treated with etanercept are at increased risk for developing serious infections that may lead to hospitalization or death. It helps in modifying the course of the disease and prevents further damage to the joints.ĮTACEPT is indicated in the treatment of: ETACEPT binds to TNF-α,a cytokine that plays a very important role in the inflammation and joint damage in rheumatic disorders. In such cases,biologics like etanercept play a significant role in controlling the disease activity and make a positive difference in the lives of these patients.Ĭipla launches ETACEPT the first biosimilar of etanercept in India.ĮTACEPT contains etanercept,a recombinant human tumour necrosis factor receptor produced by recombinant DNA technology. However,approximately 40% of these patients are not controlled with DMARDs. DMARDs are Disease modifying Antirheumatic drugs that halt disease progression and prevent further joint damage in rheumatic disorders. Currently available treatment options include NSAIDs and Steroids for symptomatic relief. Arthritis and disorders of the musculoskeletal system are among the most common chronic disorders that have a huge impact on quality of life and are the leading cause of disability worldwide.
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