Enbrel Solution for Injection in a Pre-filled Syringe 50mg

PFIZER PRIVATE LIMITED

PFIZER PRIVATE LIMITED

Therapeutic

Prescription Only

INJECTION, SOLUTION

**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**_ 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.