EPARs - 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. Cerasale. Marzo 11, 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
Selective immunosuppressive agents
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.

Psoriatic arthritis
Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.

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 cortiocosteroids. Humira can be given as monotherapy in case of intolerance to
corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).

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