Shieldex 50 mg/ml is a Product of the Generic Etanercept

What Is Shieldex 50 mg/ml Indications and Uses?

Adults with Rheumatoid Arthritis (RA) : Shieldex 50 mg/ml (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). Shieldex ... Read more Adults with Rheumatoid Arthritis (RA) : Shieldex 50 mg/ml (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). Shieldex 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. Pediatric patients with Juvenile Idiopathic Arthritis(JIA) : Shieldex 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. Adults with Psoriatic Arthritis (PsA) : Shieldex 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). Shieldex can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone. Adults with Ankylosing Spondylitis (AS) : Shieldexis indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). Adults with Plaque Psoriasis (PsO) : Shieldex 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. Pediatric patients with Plaque Psoriasis (PsO) : Shieldex 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.

Pharmacology (Source, Chemical and Physical Composition) Of Shieldex 50 mg/ml

Shieldex 50 mg/ml (Etanercept) is a tumor necrosis factor (TNF) blocker. This 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.

Side Effects of Shieldex 50 mg/ml

Very common : Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling). Reactions at the injection site (these do not occur as often after the first month of treatment. Some patients have developed a reaction at an injection site that was used before. Common : Allergic reactions; fever; itching; antibodies directed against normal tissue (autoantibody formation). Uncommon : Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); low blood platelet count; skin cancer (excluding melanoma); localized swelling of the skin (angio edema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); rash; inflammation or scarring of the lungs; inflammation of the blood vessels affecting multiple organs.

Precautions And Warnings for Shieldex 50 mg/ml

Special warning and special precautions for use- Allergic reactions Infections/surgery Infections/diabetes Infections/monitoring Tuberculosis Hepatitis-B Hepatitis-C Blood disorders Nervous system and eye disorders Congestive heart failure Cancer Chickenpox Latex Alcohol abuse Wegener's granulomatosis Anti-diabetic medicine

Use During Pregnancy and Lactation

The safe use of Shieldex 50 mg/ml (Etanercept) during pregnancy has not been established. Use etanercept during pregnancy only if clearly needed. The safe use of etanercept during lactation has not been established. It is not known whether etanercept is excreted in human milk. Following subcutaneous administration to lactating rats, etanercept was excreted in the milk and detected in the serum of the pups. Because immunoglobulins and many medicinal products can be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue etanercept while nursing.

Therapeutic Class

Immunosuppressant

Storage Conditions of It

Shieldex should be stored in refrigerator at 2-8°C. Do not freeze. Do not shake. Keep away from light. Keep out of reach of children. Pack Image: Shieldex 50 mg/ml SC Injection Thanks for using MedEx! How would you rate your experience so far?