Enbrel - Indications & Dosage

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JRA Patients

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.

The ENBREL® (etanercept) “Patient Information” insert contains more detailed instructions on the preparation of ENBREL®. Preparation of ENBREL® Using the Single-Use Prefilled Syringe: Before injection, ENBREL® single-use prefilled syringe may be allowed to reach room temperature (approximately 15 to 30 minutes). DO NOT remove the needle shield while allowing the prefilled syringe to reach room temperature. Preparation of ENBREL® Using the Multiple-use Vial: ENBREL® should be reconstituted aseptically with 1 mL of the supplied Sterile Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) giving a solution of 1.0 mL containing 25 mg ofENBREL®.

A vial adapter is supplied for use when reconstituting the lyophilized powder. However, the vialadapter should not be used if multiple doses are going to be withdrawn from the vial. If the vial will be used for multiple doses, a 25-gauge needle should be used for reconstituting and withdrawing ENBREL®, and the supplied “Mixing Date:” sticker should be attached to the vial and the date of reconstitution entered. Reconstitution with the supplied BWFI, using a 25-gaugeneedle, yields a preserved, multiple-use solution that must be used within 14 days. If using the vial adapter, twist the vial adapter onto the diluent syringe. Then, place the vial adapterover the ENBREL® vial and insert the vial adapter into the vial stopper. Push down on the plunger to inject the diluent into the ENBREL® vial. It is normal for some foaming to occur. Keeping the diluent syringe in place, gently swirl the contents of the ENBREL®vial during dissolution. Toavoid excessive foaming, do not shake or vigorously agitate.