Orencia

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abatacept

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

Overview

Orencia is a medicine that is often used in combination with methotrexate (a medicine that acts on the immune system) to treat the following diseases:

  • moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints) in adults using it in combination with methotrexate when other medicines including methotrexate or a ‘tumour necrosis factor (TNF) blocker’ have not worked well enough;
  • highly active and progressive rheumatoid arthritis, used in combination with methotrexate in adults who have not previously been treated with methotrexate;
  • moderate to severe active polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), in adolescents and children from 2 years of age in whom other medicines have not worked well enough. It is used in combination with methotrexate, or on its own in patients who cannot take methotrexate.
  • psoriatic arthritis (arthritis combined with psoriasis, a condition causing red, scaly patches on the skin) in adults in whom treatment with other medicines, including methotrexate, has not worked well enough. It is used alone or in combination with methotrexate for patients who do not need other medicines by mouth or by injection to control their psoriasis.

Orencia contains the active substance abatacept.

This EPAR was last updated on 19/07/2019

Authorisation details

Product details
Name
Orencia
Agency product number
EMEA/H/C/000701
Active substance
Abatacept
International non-proprietary name (INN) or common name
abatacept
Therapeutic area (MeSH)
  • Arthritis, Psoriatic
  • Arthritis, Juvenile Rheumatoid
  • Arthritis, Rheumatoid
Anatomical therapeutic chemical (ATC) code
L04AA24
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
21/05/2007
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Product information

08/04/2019 Orencia - EMEA/H/C/000701 - X/0117/G

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Rheumatoid arthritis
Orencia, in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
  • the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.

A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.

Psoriatic arthritis

Orencia, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required. 

Polyarticular juvenile idiopathic arthritis

Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy.

Orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.

Assessment history

Changes since initial authorisation of medicine

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