Etacept

50 mg/ml

Manufactured by:

1 ml pre-filled syringe: ৳ 13, 635.44

Indication

Rheumatoid arthritis

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.

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.

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.

Adults with Ankylosing Spondylitis (AS): Etanerceptis indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

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.

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.

Pharmacology

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.

Dosage & Administration

Interaction

Side Effects

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.

Pregnancy & Lactation

The safe use of 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.

Precautions & Warnings

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 in Special Populations

Therapeutic Class

Immunosuppressant

Overdose Effects

The maximum tolerated dose of etanercept has not been established in humans. Single intravenous doses up to 60 mg/m² have been administered to healthy volunteers in an endotoxemia study without evidence of dose-limiting toxicities. The highest dose level evaluated in rheumatoid arthritis patients has been an intravenous loading dose of 32 mg/m² followed by subcutaneous doses of 16 mg/m²(25 mg) administered twice weekly. No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients. There is no known antidote to etanercept.

Storage Conditions

Etanercept 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.

Alternative Brand Names

SC Injection

Etacept

Etanercept

25 mg/0.5 ml

0.5 ml pre-filled syringe: ৳ 8, 000.00