Enbrel Dosage/Direction for Use

Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or pediatric plaque psoriasis.
Adults (18-64 years): Rheumatoid Arthritis: 25 mg Enbrel administered twice weekly is the recommended dose. Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see Pharmacology: Pharmacodynamics under Actions).
Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis: The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.
Plaque Psoriasis: The recommended dose of Enbrel 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 Enbrel should continue until remission is achieved, for up to 24 weeks. Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see Pharmacology: Pharmacodynamics under Actions). 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: 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.
Pediatric population: 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 in paediatric use (see as follows for dosing for specific indications). Patients weighing 62.5 kg or more, may be dosed using a fixed-dose pre-filled syringe.
Polyarticular juvenile idiopathic arthritis: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose) after reconstitution of Enbrel in 1 mL of solvent, given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses. Discontinuation of treatment should be considered in patients who show no response after 4 months.
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 polyarticular 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 Enbrel is indicated, the previously menitoned 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 health care professional if Enbrel is to be administered by a patient or caregiver.
Solution for injection in pre-filled syringe: Please refer to Instructions for use Before injection, Enbrel single-use pre-filled syringes 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.
Pediatric use: Enbrel has not been studied in children <2 years of age (see Indications). For pediatric specific safety information concerning malignancies, vaccinations and inflammatory bowel disease, see Precautions and Adverse Reactions.