| Drug name | Nepexto®
|
| INN | Etanercept |
| API type | Fusion protein |
Pharmacotherapeutic group
| Immunosuppressants, tumour necrosis factor-alpha (TNF-α) inhibitors |
ATC code
| L04AB01
|
Target of antibody
| TNF alpha |
| General function | |
| Short description | Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
|
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
| The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis. In plaque psoriasis, infiltration by inflammatory cells, including T-cells, leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin. Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs). Both TNFRs exist naturally in membrane-bound and soluble forms. Soluble TNFRs are thought to regulate TNF biological activity. |
Original license holder
| Mylan IRE Healthcare Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland |
Marketing authorisation numbers
| EU/1/20/1436/001-008 |
Marketing authorisation holder
| Mylan IRE Healthcare Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland |
Name of the manufacturer of the biological active substance
| Lupin Limited (Biotech Division)
Gat No. 1156, 1157, 1158, 1159 and 1160, Village Ghotawade,
Taluka Mulshi, Dist. Pune - 412 115,
Maharashtra, India |
| Name and address of the manufacturer(s) responsible for batch release | McDermott Laboratories Ltd T/A Mylan Dublin Biologics
Newenham Court
Northern Cross
Malahide Road
Dublin 17
Ireland
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany |
Max shelf life
| 2 years |
Storage conditions
| 2°C – 8°C
|
List of excipients
| Sodium citrate
Sodium dihydrogen phosphate dihydrate
Glycine
Sucrose
Sodium chloride
Water for injections |
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