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Enbrel

[etanercept]

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). The recommended dose should be administered subcutaneously, using 50 mg/mL single-use prefilled syringes.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).

JRA Patients

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The recommended dose of ENBREL® for pediatric patients ages 4 to 17 years with active polyarticular-course JRA is 0.8 mg/kg per week (up to a maximum of 50 mg per week). For pediatric patients weighing 63 kg (138 pounds) or more, the weekly dose of 50 mg may be administered using the prefilled syringe. For pediatric patients weighing 31 to 62 kg (68 to136 pounds), the total weekly dose should be administered as two subcutaneous (SC) injections, eitheron the same day or 3 or 4 days apart using the multiple-use vial. The dose for pediatric patients weighing less than 31 kg (68 pounds) should be administered as a single SC injection once weekly using the correct volume from the multiple-use vial. 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.

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