ENBREL SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 25MG FOR SUBCUTANEOUS USE

Product Information

Registration Status: Active

ENBREL SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 25MG is approved to be sold in Singapore with effective from 2010-07-16. It is marketed by PFIZER PTE LTD, with the registration number of SIN13834P.

This product contains Etanercept 50mg/mL in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.

This product is manufactured by Vetter Pharma-Fertigung GmbH & Co. KG (Pre-filled Syringe) in BELGIUM, andPfizer Manufacturing Belgium NV (Pre-filled Syringe) in GERMANY.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Description

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.

Indication

Etanercept is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults and chronic moderate to severe plaque psoriasis in adults. It is also used to manage signs and symptoms of polyarticular idiopathic arthritis in those aged 4 to 17 after insufficient response to one or more disease-modifying anti-rheumatic drugs. Etanercept is also used to improve psoriatic arthritis and ankylosing spondylitis.

Mechanism of Action

There are two distinct receptors for TNF (TNFRs), a 55 kilodalton protein (p55) and a 75 kilodalton protein (p75). The biological activity of TNF is dependent upon binding to either cell surface receptor (p75 or p55). Etanercept is a dimeric soluble form of the p75 TNF receptor that can bind to two TNF molecules, thereby effectively removing them from circulation. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Increased levels of TNF are found in tissues and fluids of those with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (AS), and plaque psoriasis.

Pharmacokinetics

Absorption: Bioavailability following sub-Q administration is approximately 60%. Peak plasma concentrations achieved within 69 hours.
Distribution
Metabolism
Elimination

Clearance

* 160 +/- 80 mL/hr [RA patients]

Active Ingredient/Synonyms

Source of information: Drugbank (External Link). Last updated on: 3^rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.