Enbrel

[etanercept]

Generally, dissolution of ENBREL® takes less than 10 minutes. Visually inspect the solution forparticulate matter and discoloration prior to administration. The solution should not be used ifdiscolored or cloudy, or if particulate matter remains.

Withdraw the correct dose of reconstituted solution into the syringe. Some foam or bubbles may remain in the vial. Remove the syringe from the vial adapter or remove the 25-gauge needle fromthe syringe. Attach a 27-gauge needle to inject ENBREL®.

The contents of one vial of ENBREL® solution should not be mixed with, or transferred into, the contents of another vial of ENBREL®. No other medications should be added to solutions containing ENBREL®, and do not reconstitute ENBREL® with other diluents. Do not filter reconstituted solution during preparation or administration.

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Reconstitution with the supplied BWFI, using a 25-gauge needle, yields a preserved, multiple-usesolution that must be used within 14 days. Discard reconstituted solution after 14 days.

PRODUCT STABILITY AND STERILITY CANNOT BE ASSURED AFTER 14 DAYS.

Administration of ENBREL®

A 50 mg dose should be given as one SC injection using a 50 mg/mL single-use prefilled syringe oras two 25 mg SC injections using the multiple-use vial. The two 25 mg injections should be giveneither on the same day or 3 or 4 days apart (see CLINICAL STUDIES). Rotate sites for injection (thigh, abdomen, or upper arm). Never inject into areas where the skin istender, bruised, red, or hard. See the ENBREL® (etanercept) “Patient Information” insert for detailed information on injection site selection and dose administration.

Storage and Stability

ENBREL® single-use prefilled syringe: Do not use a prefilled syringe beyond the expiration date stamped on the carton or syringe barrel label. The prefilled syringes must be refrigerated at 2° to8°C (36° to 46°F). DO NOT FREEZE. Keep the ENBREL® prefilled syringes in the originalcarton to protect from light until the time of use. Do not shake.

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