Benepali™ 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 Benepali™ should be given the Patient Card.

DOSlNG BENEPALl™ lN ADULTS1

Please refer to the BenepaliTM Summary of Product Characteristics for full information.

RHEUMATOlD ARTHRlTlS (RA)

The recommended dose is 25 mg etanercept administered twice weekly. Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see Section 5.1 of the Summary of Product Characteristics).

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.

PSORIATIC ARTHRITIS

The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.

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.

ANKYLOSING SPONDYLITIS

The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.

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.

NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS

The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.

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 a dose of 50 mg once weekly.

Treatment with Benepali™ 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 of the Summary of Product Characteristics).

Treatment should be discontinued in patients who show no response after 12 weeks.

If re-treatment with Benepali™ is indicated, the same guidance on treatment duration should be followed. The dose should be 25 mg twice weekly or 50 mg once weekly.

DOSlNG BENEPALI™ lN CHlLDREN AND ADOLESCENTS1

Benepali™ is only available as a 25 mg pre-filled syringe, a 50 mg pre-filled syringe, and a 50 mg pre-filled pen. Thus, it is not possible to administer Benepali™ 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 Benepali™.

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 powder for solution for injection presentations. Patients weighing 62.5 kg or more, may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.

JUVENlLE lDlOPATHlC ARTHRlTlS

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 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 of the Summary of Product Characteristics).

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 Benepali™ 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.

DOSlNG BENEPALI™ lN OTHER SPEClAL POPULATlONS1

ELDERLY

No dose adjustment is required. Posology and administration are the same as for adults 18-64 years of age.

RENAL AND/OR HEPATlC lMPAlRMENT

No dose adjustment is required. Please refer to the BenepaliTM Summary of Product Characteristics for full information.

CONTRAINDICATIONS1

Hypersensitivity to the active substance or to any of the excipients:

Sucrose

Sodium chloride

Sodium dihydrogen phosphate monohydrate

Disodium hydrogen phosphate heptahydrate

Water for injections

 

Sepsis or risk of sepsis.

 

Treatment with Benepali should not be initiated in patients with active infections, including chronic or localised infections.

 

See the full Summary of Product Characteristics for further information.