ENBREL (Page 15 of 16)

Instructions for Use Enbrel® (en-brel) (etanercept) injection, for subcutaneous use single-dose vial

Read this Instructions for Use before you start taking Enbrel and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition and treatment.

Step 1: Set up


1a. Strength and dose

The strength of the Enbrel single-dose vial is different than the Enbrel multiple-dose vial.

Each single-dose vial contains 25 mg (0.5 mL).

Review your prescription carefully for dose and dosing schedule. Only inject Enbrel after you or your caregiver has received training by your healthcare provider. Your healthcare provider will tell you how often you should use Enbrel. Do not use Enbrel more often than directed by your healthcare provider. If you forget to use Enbrel, inject your dose right away. Inject your next dose at your regular scheduled time. If you do not know when to inject Enbrel, call your healthcare provider or pharmacist.

Keep Enbrel out of the reach of children.


1b. Store Enbrel single-dose vials

Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C). You may also store the Enbrel single-dose vials at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days. Throw away Enbrel that has been stored at room temperature after 14 days.

Do not shake.

Do not freeze or store in extreme heat or cold.

Store Enbrel in the original carton to protect from light or damage.

If your dose is 0.5 mL, or LESS


Remove 1 single-dose vial
If your dose is MORE than 0.5 mL


Remove 2 single-dose vials

1c. Remove correct number of vials

Remove the correct number of Enbrel single-dose vials from the original carton.

Check your prescription to determine if your dose will require 1 or 2 single-dose vials.

Your dose is determined in milliliters (mL).

Your child’s dose of Enbrel depends on his or her weight. Your child’s healthcare provider will tell you which form of Enbrel to use and how much to give your child.

Green vial cap WAIT


1d. Inspect the single-dose vial(s)

Leave the single-dose vial(s) at room temperature, with the green cap(s) on, for at least 30 minutes.

Enbrel is clear and colorless. There may be small white particles in the solution. Check the expiration date.

Keep out of direct sunlight.

Do not use Enbrel if:

  • the expiration date has passed
  • the green cap is not attached
  • it has lumps, is discolored, or is cloudy.

If there are any issues with your Enbrel single-dose vials, please call 1-888-4ENBREL (1-888-436-2735).

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1e. Gather all materials and wash hands

Wash your hands with soap and water.

Place the following items on a clean well-lit, flat surface:

  • 1 mL syringe
  • Long needle: for withdrawal
  • Short needle: for injection
  • Alcohol wipes
  • Cotton balls
  • Bandage
  • Sharps disposal container
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1f. Pop off the green vial cap then wipe the gray stopper

Use an alcohol wipe to clean the gray stopper.

If you require a second single-dose vial, clean the gray stopper of the second single-dose vial with a new alcohol wipe.


1g. Attach the long needle to the syringe

Twist the long needle onto the syringe.

Step 2: Prepare dose

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2a. Pull plunger back, insert needle, and push air into single-dose vial

Pull the needle cap straight off and away from your body. Save the needle cap for later.

Pull the syringe plunger back to 0.5 mL.

Hold the single-dose vial on a flat surface with 1 hand. Insert the long needle through the gray rubber stopper above the medicine in the single-dose vial.

Slowly push 0.5 mL of air into the single-dose vial.


2b. Tilt the single-dose vial to withdraw all medicine

Slowly pull back the plunger to fill the syringe with all the medicine from the single-dose vial.

Remove needle from the single-dose vial.

The air in the syringe will be removed later.


2c. Gently tap the syringe with fingers to release bubbles

Gently tap the syringe with your fingers to release air pockets and bubbles until they rise to the top of the syringe.


2d. Push out large air pockets and bubbles

After you have gently tapped the large air pockets and bubbles to the top of the syringe, push the plunger up to remove the air out of the syringe.

Small amounts of tiny air bubbles are ok.

If you need 1 single-dose vial, push the plunger to your total prescribed dose and continue to step 2g.

If you need more than 1 single-dose vial to get your total prescribed dose , follow these 2 steps:


2e. Insert the same needle in the second vial Tilt vial to withdraw medicine. Slowly pull back the plunger to fill the syringe with all medicine from the vial. Remove the needle from the single-dose vial. The air will be removed in the next step2f. Gently tap the syringe to remove the air Hold the needle pointing up and gently tap the syringe so air bubbles rise to the top. Push the plunger to your prescribed dose. Small amounts of tiny air bubbles are ok.

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2g. Use 1-handed scoop method to recap For your safety, place the needle cap on a flat surface.

Using 1 hand , slide the needle into the cap and scoop upwards to cap the needle, without using your other hand.

Then use your other hand to secure the cap and snap into place.

Step 3: Inject and throw away

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3a. Replace the long needle with the short needle

Twist the long needle off of the syringe.

Throw away the long needle in the sharps disposal container.

Twist the short needle onto the syringe.

Do not remove the needle cover until you are ready to inject.


3b. Choose and clean the injection site

  • thigh or stomach (avoid 2 inches around the navel)
  • back of upper arm (only if someone else is giving the injection)

Choose a different site each time you give yourself an injection. Avoid injecting into tender, raised, red or scaly skin.

Clean the injection site with an alcohol wipe and let dry. Do not touch this area again before injecting.


3c. Pinch and inject Enbrel

Gently pinch skin. With a quick firm action, insert the needle into your skin at a 45-degree angle.

When the needle is completely inserted into the skin, slowly push the plunger all the way down.

When the syringe is empty, remove the needle and syringe from your skin. Do not recap the needle.

Do not rub the injection site. If you see drops of blood at the injection site, you can press a cotton ball over the injection site until bleeding has stopped. Apply an adhesive bandage, if needed.


3d. Throw away the used single-dose vials, needles and syringe

Single-dose vials do not contain preservatives and are for 1-time use only. Unused medicine in the single-dose vials must be thrown away in a sharps disposal container.

Additional disposal information

Do not throw away the vials, needles, and syringe in your household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

  • made of a heavy-duty plastic
  • can be closed with a tight-fitting, puncture-resistant lid without sharps being able to come out
  • upright and stable during use
  • leak-resistant
  • properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to throw away your sharps disposal container. There may be state or local laws about how you should throw away used vials, needles and syringes.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

  • Do not throw away your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
  • Do not reuse the vials, syringe, or needles.
  • Do not recycle the vials, syringe, needles, or sharps disposal container or throw them into household trash.

Important: Always keep the sharps disposal container out of the reach of children.

If you experience any difficulty using your Enbrel single-dose vials, please call 1-888-4ENBREL (1-888-436-2735).

If you have any questions about your Enbrel dosing, please call your healthcare provider.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.


Manufactured by:
Immunex Corporation
Thousand Oaks, CA 91320-1799
U.S. License Number 1132
© 2020 Immunex Corporation. All rights reserved.
[part number] Issued: 03/2020 v1

ImageThis printed material is recyclable.

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Read these instructions before using Enbrel® Single-Dose VialInstructions for Use

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