Posology : מינונים

4.2    Posology and method of administration

Erelzi 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.

Erelzi pre filled syringe is available in strengths of 25 mg and 50 mg. The Erelzi pre- filled pen is available in a 50 mg strength.

Posology
Rheumatoid arthritis
Etanercept 25 mg administered twice weekly is the recommended dose. Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).

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 dosage 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 presentations (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.

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).

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 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.


Method of administration

Erelzi is administered by subcutaneous injection (see section 6.6).

Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe” or “Instructions for use of the Erelzi SensoReady pen”.