EPARs human use - Humira//adalimumab

FICHA FARMACOLÓGICA de adalimumab. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. JUNIO 25, 2009.-

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EPARs for authorised medicinal products for human use - Humira

Active Substance
adalimumab
International Nonproprietary Name or Common Name
adalimumab
Pharmaco-therapeutic Group
Tumor necrosis factor alpha (TNF-α) inhibitors
ATC Code
L04AB04

Therapeutic Indication:
Rheumatoid arthritis
Humira in combination with methotrexate, is indicated for:

- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

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

Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Polyarticular juvenile idiopathic arthritis:
Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in adolescents aged 13 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Psoriatic arthritis:
Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti‑rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.

Ankylosing spondylitis:
Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Crohn’s disease:
Humira is indicated for treatment of severe, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. For induction treatment, Humira should be given in combination with corticosteroids. Humira can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.
Psoriasis:
Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.


Date of issue of Marketing Authorisation valid throughout the European Union
8 September 2003

Orphan medicinal product designation date
Not applicable

EPARs for authorised medicinal products for human use