Nepexto

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etanercept

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 26/11/2020

Authorisation details

Product details
Name
Nepexto
Agency product number
EMEA/H/C/004711
Active substance
etanercept
International non-proprietary name (INN) or common name
etanercept
Therapeutic area (MeSH)
  • Arthritis, Rheumatoid
  • Arthritis, Juvenile Rheumatoid
  • Arthritis, Psoriatic
  • Spondylarthropathies
  • Spondylitis, Ankylosing
  • Psoriasis
Anatomical therapeutic chemical (ATC) code
L04AB01
Additional monitoringAdditional 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.

BiosimilarBiosimilar

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
Marketing-authorisation holder
Mylan IRE Healthcare Limited
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
20/05/2020
Contact address

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Product information

23/10/2020 Nepexto - EMEA/H/C/004711 - IAIN/0004

Contents

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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.

Assessment history

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