Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly. For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period. 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 (see section 5.1). 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. Elderly No dose adjustment is required. Posology and administration are the same as for adults 18–64 years of age.
Paediatric population Erelzi is only available as 25 mg pre-filled syringe and 50 mg pre-filled syringe and pre-filled pen. Thus, it is not possible to administer Erelzi to paediatric patients that require less than a full 25 mg or 50 mg dose. Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Erelzi. If an alternate dose is required, other etanercept products offering such an option should be used. The dose of etanercept is based on body weight for paediatric patients.
Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or the powder for solution for injection presentation (see below for dosing for specific indications). Patients weighing 62.5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen. The safety and efficacy of Erelzi in children aged less than 2 years has not been established. No data are available.
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. A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg. 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 (see section 5.1). 4