ENBREL SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 25MG [SIN13834P]

Product Info

ENBREL SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 25MG

[SIN13834P]

4.1 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. ENBREL 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

ENBREL is indicated for reducing signs and symptoms of active arthritis in adult patients with psoriatic arthritis. ENBREL 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

ENBREL 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 chronic plaque psoriasis who failed to respond to, or who have contraindications to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA.

Paediatric Patients with Plaque Psoriasis

ENBREL 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.

4.2 Posology and Method of Administration

ENBREL 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.

Use in Adults (18–64 years)

Rheumatoid Arthritis

25 mg ENBREL 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 5. PHARMACOLOGICAL 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 Spondyloarthritis

The recommended dose is 25 mg ENBREL administered twice weekly (72 to 96 hours apart), 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 ENBREL 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 ENBREL 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 ENBREL 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 ENBREL 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 ENBREL 25 mg/mL powder and solvent for solution for injection (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 (age 2 years and above)

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.

The 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 ENBREL 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 ENBREL 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 ENBREL in children aged below 6 years in the indication plaque psoriasis.

Method of Administration

Administer ENBREL as subcutaneous injections in the thigh, abdomen, or upper arm. Give each new injection at least 3 cm from a previous site. Do NOT inject into areas where the skin is tender, bruised, red, or hard.

Patients or caregivers who are to administer ENBREL must be instructed in injection techniques. The first injection should be performed under the supervision of a qualified healthcare professional if ENBREL is to be administered by a patient or caregiver.

Powder and Solvent for Solution for Injection

Patients or caregivers who are to administer ENBREL must be instructed in mixing the powder with the liquid.

ENBREL should be reconstituted aseptically with 1 mL of the supplied Sterile Water for Injection. During reconstitution of ENBREL, the solvent should be slowly injected into the vial. Some foaming will occur. To avoid excessive foaming, do not shake or vigorously agitate. The contents should be swirled gently during dissolution. Generally, dissolution of ENBREL takes less than 10 minutes. The reconstituted ENBREL solution is colourless to slightly yellow or pale brown and clear to slightly opalescent liquid.

Visually inspect the solution for particulate matter and discolouration prior to administration. The solution should not be used if discoloured or cloudy, or if particulate matter remains. Withdraw the solution into the syringe, removing as much liquid as possible from the vial. Some foam or bubbles may remain in the vial. The final volume in the syringe will be approximately 1 mL.

No other medications should be added to solutions containing ENBREL, and ENBREL should not be reconstituted with other solvents. Do not filter reconstituted solution during preparation or administration.

Solution for Injection in Pre-filled Syringe

Before injection, ENBREL single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature. The solution should be clear to opalescent, colourless to yellow or pale brown, and liquid may contain trace levels of translucent to white amorphous particles.

Solution for Injection in Pre-filled Pen

Before injection, ENBREL single-use pre-filled pens should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cover should not be removed while allowing the pre-filled pen to reach room temperature. The pen should not be left at room temperature for more than 12 hours. By looking through the inspection window, the solution should be clear to opalescent, colourless to yellow or pale brown, and liquid may contain trace levels of translucent to white amorphous particles.

Missed Doses

If a dose is missed, patients should be advised to administer the dose as soon as they remember, unless the next scheduled dose is the next day, in which case the missed dose should be skipped. Patients should continue to inject the medicine on their usual day(s). If a patient does not remember until the day that the next injection is due, instruct the patient not to take a double dose.

4.3 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 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).