Posology : מינונים

4.2   Posology and method of administration

Brenzys 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. Patients treated with Brenzys should be given the Patient safety information Card.
Brenzys is available in strength of 50 mg.
Other etanercept products with appropriate dosage for children are available.
Please note etanercept products are not interchangeable.

Posology

Rheumatoid arthritis
The recommended dose is 50 mg etanercept administered once weekly (see section 5.1).
Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis The recommended dose is 50 mg etanercept 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 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 50 mg once weekly.
Treatment with Brenzys 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 Brenzys is indicated, the same guidance on treatment duration should be followed. The dose should be 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
Brenzys is only available as 50 mg pre-filled syringe and 50 mg pre-filled pen.
Thus, it is not possible to administer Brenzys to paediatric patients that require less than a full 50 mg dose. Paediatric patients who require a dose other than a full 50 mg should not receive Brenzys. If an alternate dose is required, other etanercept products offering such an option should be used.

Juvenile idiopathic arthritis
The recommended dose is 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.

Intended for patients weighing 62.5 kg or more.
Paediatric plaque psoriasis (patients weighing 62.5 kg or more)
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 Brenzys 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.

Intended for patients weighing 62.5 kg or more.

Method of administration
Brenzys is for subcutaneous use (see section 6.6).
Comprehensive instructions for administration are given in the package leaflet, section 7, “Instructions for use”.