Información de la droga para ENBREL (etanercept) For Subcutaneous Injection (Immunex Corp): Patient Instructions for UseENBREL® (en-brel)(etanercept)Single-use Prefilled SureClick™ Autoinjector

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  • How do I prepare and give an injection with ENBREL® Single-use Prefilled SureClick™ Autoinjector?

    This section contains information on how to properly use the ENBREL® SureClick™ autoinjector. It is important that you do not try to give yourself the injection unless you have received special training from your doctor, nurse or pharmacist.

    A single-use prefilled SureClick™ autoinjector contains one 50 mg dose of ENBREL®.

    Children must weigh at least 138 pounds to use ENBREL® single-use prefilled Sureclick™ autoinjector. Children who weigh less than 138 pounds should use a different form of ENBREL®.

    IMPORTANT: The needle cap on the single-use prefilled SureClick™ autoinjector contains latex. Tell your doctor if you are allergic to latex.

    Equipment:

    • A new ENBREL® SureClick™ autoinjector, and
    • Alcohol wipes or similar
    • Cotton ball or gauze
    • Puncture resistant disposable container

    Preparing for an ENBREL® Injection

    • Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
    • Remove one single-use prefilled ENBREL® SureClick™ autoinjector from the carton. Do not shake the autoinjector. Place the carton containing any remaining autoinjectors back into the refrigerator (2° to 8°C [36° to 46°F]). Do not freeze. If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
    • Check the expiration date on the autoinjector label. Do not use if the date has passed the last day of the month shown.
    • Make sure the solution in the autoinjector is clear and colorless by looking through the inspection window. You may notice small white particles in solution. These particles are formed from ENBREL® and this is acceptable. However, do not inject the solution if it is cloudy or discolored, or contains large or colored particles - contact your pharmacist or call 1-888-4ENBREL (1-888-436-2735) for assistance.
    • For a more comfortable injection, wait 15 to 30 minutes to allow the autoinjector to reach room temperature. Do not remove the white needle cap while allowing it to reach room temperature. Do not warm ENBREL® in any other way (for example, do not warm it in a microwave or in hot water).
    • Wash your hands thoroughly.
    • Do not remove the white needle cap from the autoinjector until you are ready to inject.

    Choosing and Preparing an Injection Site

    Choose an Injection Site

    The injection site must be firm for the autoinjector to work properly. The preferred injection site for ENBREL® using a prefilled SureClick™ autoinjector is the front of the thigh.

    • Rotate Injection LocationRotate the site for each injection. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with stretch marks.
    • Patients with PsoriasisIf you have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches or lesions.

    Instructions for Preferred Injection Site

    The front of the thigh is the preferred injection site.

    Instructions for Alternate Injection Sites

    When using alternate injection sites, it is particularly important to create enough firmness on the site to be able to successfully complete the injection.

    Stretch technique

    Make sure the skin under and around the prefilled autoinjector is firm and taut to provide enough resistance to fully retract the safety guard and unlock the prefilled autoinjector.
    You can use the abdomen, except for the two-inch area right around the navel. Stretch the skin at the injection site to create a firm and taut surface.
    If someone else is giving you the injection, they can also use the outer area of the upper arms. For the upper arms, it is recommended to stretch the skin at the injection site to create a firm and taut surface.

    Prepare the site

    To prepare the area of skin where ENBREL® is to be injected, wipe the injection site with an alcohol swab. Do not touch this area again before giving the injection.

    Injecting ENBREL® Using a Single-use Prefilled SureClick™ Autoinjector

    1. Pull off the white needle cap.

    ?Do not twist the white needle cap
    ?Do not re-attach needle cap onto the prefilled autoinjector
    ?Do pull the white cap straight off.
    2. Do not touch the purple button. Press prefilled autoinjector onto skin to unlock safety guard.

    ?Do not press the purple button until the safety guard is fully retracted.
    ?Do keep enough downward pressure to fully retract the purple safety guard and to keep the purple button unlocked.
    ?Do hold the prefilled autoinjector at a right angle (90º) at the injection site.

    3. Briefly press and release purple button.

    ?Do maintain pressure on the skin during the injection.

    4. Count slowly to 15 seconds for injection to end.

    ?Do not move the prefilled autoinjector during the injection.
    ?Do wait for the injection to finish before releasing pressure.
    ?You might hear a second click as the purple button pops back up.

    After the Injection

    • Check window to confirm delivery of full dose.
    • There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.
    • Do not rub the injection site. If needed, you may cover the injection site with a bandage.

    Remember

    If you have any problems, please call 1-888-4ENBREL (1-888-436-2735) for assistance.

    Disposing of Supplies

    The SureClick™ autoinjector should NEVER be reused.

    Dispose of the used autoinjector as instructed by your healthcare provider, or by following these steps:

    • Do not throw the used autoinjector in the household trash or recycle.
    • Place the used autoinjector in a hard plastic disposal container with a screw-on cap or a metal container with a plastic lid, such as a coffee can, labeled “used syringes.” If a metal container is used, cut a small hole in the plastic lid and tape the lid to the metal container. If a hard plastic container is used, always screw the cap on tightly after each use. Do not use glass or clear plastic containers. Puncture-resistant containers may also be purchased at your local pharmacy.
    • When the container is full, tape around the cap or lid to make sure the cap or lid does not come off.
    • You should always check first with your healthcare provider for instructions on how to properly dispose of a filled disposal container. There may be special state and local laws for disposing of used needles and syringes, including autoinjectors. Do not throw the disposal container in household trash. Do not recycle.
    • Always keep the container out of the reach of children.

    A healthcare provider familiar with ENBREL® should answer all questions. A toll free information service is also available: 1 888 4ENBREL (1 888 436 2735).

    [Amgen]

    [Wyeth]

    Manufactured by:Immunex Corporation,Thousand Oaks, CA 91320-1799Marketed by Amgen Inc. and Wyeth Pharmaceuticals

    © 1998 – 2008 Immunex Corporation. All rights reserved.

    1XXXXXX - v1Issue Date: 06/2008

  • Drug Information Provided by National Library of Medicine (NLM).
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