The safety and efficacy of Enbrel in children aged less than 2 years has not been established. Posology and administration are the same as for adults 18-64 years of age. The dose should be 25 mg twice weekly or 50 mg once weekly. If re-treatment with Enbrel is indicated, the same guidance on treatment duration should be followed.

Treatment should be discontinued in patients who show no response after 12 weeks. Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1). Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly. The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once weekly. Continued therapy should be carefully reconsidered in a patient not responding within this time period. The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.įor all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1). Patients treated with Enbrel should be given the Patient Card.Įnbrel is available in strengths of 10, 25 and 50 mg.Ģ5 mg Enbrel administered twice weekly is the recommended dose. 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.Įnbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric 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) (see section 5.1). 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). Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Enbrel 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. Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. 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.

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 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.

Date of first authorisation/renewal of the authorisationĮnbrel 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.Įnbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Įnbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.Įnbrel, 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.

6.6 Special precautions for disposal and other handling.

4.7 Effects on ability to drive and use machines.

4.5 Interaction with other medicinal products and other forms of interaction.

4.4 Special warnings and precautions for use.

4.2 Posology and method of administration.

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