HiPhi Erelzi (etanercept) Summary of Product Characteristics (EN)

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1

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SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT Erelzi 25 mg solution for injection in pre-filled syringe Erelzi 50 mg solution for injection in pre-filled syringe Erelzi 50 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Erelzi 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept. Erelzi 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept. Erelzi 50 mg solution for injection in pre-filled pen Each pre-filled pen contains 50 mg of etanercept.

Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) Solution for injection (injection) in pre-filled pen (SensoReady pen) The solution is clear or slightly opalescent, colourless to slightly yellowish. 4.

CLINICAL PARTICULARS 4.1 Therapeutic indications Rheumatoid arthritis Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis 2

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SUMMARY OF PRODUCT CHARACTERISTICS

Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).

Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. 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. Patients treated with Erelzi should be given the Patient Card. Erelzi is available in strengths of 25 mg and 50 mg.

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 (see section 5.1). 3

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SUMMARY OF PRODUCT CHARACTERISTICS

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

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