50 mg dose should be given as one subcutaneous (SC) injection using either a 50 mg single-use prefilled syringe or a single-use prefilled SureClick autoinjector. A 50 mg dose can also be given as two 25 mg SC injections using 25 mg single-use prefilled syringes or multiple-use vials.
When administering ENBREL® as two injections in adults or children, the injections should be given either on the same day or 3 or 4 days apart (see CLINICAL STUDIES).
Sites for injection (thigh, abdomen, or upper arm) should be rotated. Never inject into areas where the skin is tender, bruised, red, or hard. See the ENBREL® (etanercept) “Patient Instructions for Use” insert for detailed information on injection site selection and dose administration.
Adult RA, AS, and Psoriatic Arthritis Patients
The recommended dose of ENBREL® for adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis is 50 mg per week. Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL®. Based on a study of 50 mg ENBREL® twice weekly in patients with RA that suggested higher incidence of adverse reactions but similar ACR response rates, doses higher than 50 mg per week are not recommended (see ADVERSE REACTIONS).
Adult Plaque Psoriasis Patients
The recommended starting dose of ENBREL® for adult patients is a 50 mg dose given twice weekly (administered 3 or 4 days apart) for 3 months followed by a reduction to a maintenance dose of 50 mg per week (see CLINICAL STUDIES).
Starting doses of ENBREL® of 25 mg or 50 mg per week were also shown to be efficacious. The proportion of responders were related to ENBREL® dosage (see CLINICAL STUDIES).
JIA Patients
The recommended dose of ENBREL® for pediatric patients ages 2 to 17 years with active polyarticular-course JIA is 0.8 mg/kg per week (up to a maximum of 50 mg per week). The 25 mg prefilled syringe is not recommended for pediatric patients weighing less than 31 kg (68 pounds). The 50 mg prefilled syringe or SureClick autoinjector may be used for pediatric patients weighing 63 kg (138 pounds) or more. Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with ENBREL®. Concurrent use with methotrexate and higher doses of ENBREL® have not been studied in pediatric patients.
Preparation of ENBREL®
ENBREL® is intended for use under the guidance and supervision of a physician. Patients may self-inject when deemed appropriate and if they receive medical follow-up, as necessary. Patients should not self-administer until they receive proper training in how to prepare and administer the correct dose.
The ENBREL® (etanercept) “Patient Instructions for Use” insert contains more detailed instructions on the preparation of ENBREL®.
Preparation of ENBREL® Using the Single-use Prefilled Syringe:
Before injection, ENBREL® may be allowed to reach room temperature (approximately 15 to 30 minutes). DO NOT remove the needle cover while allowing the prefilled syringe to reach room temperature.
Prior to administration, visually inspect the solution for particulate matter and discoloration. There may be small white particles of protein in the solution. This is not unusual for proteinaceous solutions. The solution should not be used if discolored or cloudy, or if foreign particulate mat |
