Nepexto
etanercept
Table of contents
Overview
Nepexto is an anti-inflammatory medicine for treating the following immune system diseases:
- rheumatoid arthritis (a disease causing inflammation of the joints), used with another medicine, methotrexate, or alone;
- certain forms of juvenile idiopathic arthritis (diseases causing inflammation in the joints);
- plaque psoriasis (a disease causing red, scaly patches on the skin);
- psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
- axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and non-radiographic axial spondyloarthritis which is when there are clear signs of inflammation but X-ray does not show disease.
Nepexto is mostly used in adults when their condition is severe, moderately severe, or getting worse, or when patients cannot use other treatments. For more information on the use of Nepexto in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Nepexto is a ‘biosimilar medicine’. This means that Nepexto is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Nepexto is Enbrel. For more information on biosimilar medicines, see here.
Nepexto contains the active substance etanercept.
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List item
Nepexto : EPAR - Medicine overview (PDF/144.03 KB)
First published: 04/06/2020
EMA/167604/2020 -
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List item
Nepexto : EPAR - Risk-management-plan summary (PDF/199.06 KB)
First published: 04/06/2020
Last updated: 22/02/2021
Authorisation details
Product details | |
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Name |
Nepexto
|
Agency product number |
EMEA/H/C/004711
|
Active substance |
etanercept
|
International non-proprietary name (INN) or common name |
etanercept
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AB01
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Biosimilar |
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines. |
Publication details | |
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Marketing-authorisation holder |
Biosimilar Collaborations Ireland Limited
|
Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
20/05/2020
|
Contact address |
Unit 35/36 |
Product information
30/08/2023 Nepexto - EMEA/H/C/004711 - T/0026
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Rheumatoid arthritis
Nepexto in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Nepexto can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Nepexto is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Nepexto, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Juvenile idiopathic arthritis
Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Etanercept has not been studied in children aged less than 2 years.
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Axial spondyloarthritis
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Non-radiographic axial spondyloarthritis
Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
Plaque psoriasis
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).
Paediatric plaque psoriasis
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, other systemic therapies or phototherapies.