Etveza Dosage/Direction for Use

Posology: Rheumatoid arthritis: 25 mg Etanercept administered twice weekly is the recommended dose. Alternatively, 50 mg administered once weekly has been shown to be safe and effective.
Psoriatic arthritis and ankylosing spondylitis: The recommended dose is 25 mg Etanercept administered twice weekly, or 50 mg administered once weekly.
Plaque psoriasis: 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.
SPECIAL POPULATIONS: Renal and hepatic impairment: No dose adjustment is required.
Older people (>65 years): No dose adjustment is required. Posology and administration are the same as for adults 18-64 years of age.
Paediatric population: Juvenile idiopathic arthritis: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Discontinuation of treatment should be considered in patients who show no response after 4 months.
No formal clinical trials have been conducted in children aged 2 to 3 years. However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously. There is generally no applicable use of Etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis.
Paediatric plaque psoriasis (age 6 years and above): 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 previously mentioned 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.
METHOD OF ADMINISTRATION: Etanercept is administered by subcutaneous injection. The injection sites could be thighs, abdomen and upper arms.
Etanercept is reconstituted with 1ml WFI before use. The reconstituted solution could be stored at 2-8°C in confined environment for 72 hours.