NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 25 MG/0.5 ML [SIN16531P]

Product Info

NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 25 MG/0.5 ML

[SIN16531P]

Therapeutic indications

Adults with Rheumatoid arthritis

Treatment of signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis. Etanercept can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

Paediatric Patients with Juvenile Idiopathic arthritis

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.

Adults with Psoriatic Arthritis

Etanecept is indicated for reducing signs and symptoms of active arthritis in adult patients with psoriatic arthritis. Etanecept can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

Axial Spondyloarthritis

Adults with Ankylosing Spondylitis (AS)

Treatment of signs and symptoms of active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.

Adults with Non-radiographic Axial spondyloarthritis

Etanercept is indicated for the treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated CRP and/or MRI evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs).

Adults with 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 PUVA.

Pediatric Patients with Plaque Psoriasis

Etanercept is indicated for the 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.

Posology and Method of Administration

Nepexto 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 pediatric plaque psoriasis.

Use in Adults (18–64 years)

Rheumatoid arthritis

25 mg etanercept administered twice weekly (72 to 96 hours apart) is the recommended dose. Alternatively, 50 mg administered once weekly has been shown to be safe and effective. Refer to section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Apondyloarthritis

The recommended dose is 25 mg etanercept administered twice weekly (72 to 96 hours apart), or 50 mg administered once weekly.

For all 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 (72 to 96 hours apart) 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 Nepexto should continue until remission is achieved, for up to 24 weeks. Continuous therapy beyond 24 weeks may be appropriate for some adult patients.

Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Nepexto 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

Elderly (≥65 years)

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

Renal and Hepatic Impairment

No dose adjustment is required.

Use in Children

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 etanercept 25 mg/mL powder and solvent for solution for injection. Patients weighing 62.5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.

Nepexto is available as 25 mg pre-filled syringe and 50 mg pre-filled syringe. Thus, it is not possible to administer Nepexto to pediatric patients that required less than a full 25 mg or 50 mg dose. Pediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Nepexto. If an alternate dose is required, other etanercept products offering such an option should be used.

Juvenile Idiopathic Arthritis

The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly (72 to 96 hours apart) 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 Juvenile Idiopathic Arthritis (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.

There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis.

Pediatric 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 Nepexto 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

Nepexto is for subcutaneous use.

Contraindications

Hypersensitivity to etanercept or to any component of the product formulation.

Active tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see Section Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).