Active Ingredient: Etanercept
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).
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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Subcutaneous, 25 milligrams etanercept, 2 times weekly, over the duration of 24 weeks.
Regimen B: Subcutaneous, 50 milligrams etanercept, once weekly, over the duration of 24 weeks.
Regimen C: Subcutaneous, 50 milligrams etanercept, 2 times weekly, over the duration of 12 weeks. Afterwards, subcutaneous, 25 milligrams etanercept, 2 times weekly, over the duration of 12 weeks.
Regimen D: Subcutaneous, 50 milligrams etanercept, 2 times weekly, over the duration of 12 weeks. Afterwards, subcutaneous, 50 milligrams etanercept, once weekly, over the duration of 12 weeks.
The recommended dose of etanercept is 25 mg administered twice weekly or 50 mg administered once weekly. 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. Treatment with etanercept should continue until remission is achieved, for up to 24 weeks. Continuous therapy beyond 24 weeks may be appropriate for some adult patients.
Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with etanercept is indicated, the same guidance on treatment duration should be followed. The dose should be 25 mg twice weekly or 50 mg once weekly.
For:
Subcutaneous, 0.8 milligrams etanercept per kilogram of body weight, once weekly, over the duration of 24 weeks.
The recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks.
If re-treatment with etanercept is indicated, the above guidance on treatment duration should be followed. The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly.
There is generally no applicable use of etanercept in children aged below 6 years in the indication plaque psoriasis.
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