Free-hand Method

For some children, one vial of ENBREL solution can be used for more than one dose. The following instructions are for preparing and giving a dose of ENBREL for children who withdraw more than one dose from the same vial. Ask your child's doctor or healthcare professional if you have any questions about which method to use.

In the free-hand method, a 25-gauge needle (not supplied) is used to help you mix the powder with the liquid and withdraw ENBREL, and a 27-gauge needle (included for first-time use) is used to inject the dose. For each additional dose, you will need two new needles (one 25-gauge needle to withdraw the solution and one 27-gauge needle for injection) and one new empty syringe (1 mL Luer-lok® - not supplied). Contact your child's doctor or healthcare provider to get additional syringes (1 mL Luer-lok®) and needles (25-gauge for mixing and withdrawing ENBREL and 27-gauge for injecting ENBREL).

The correct dose for your child will change depending on your child's body weight. Your child's doctor will inform you of the right dose to use and whether the dose should be given as one or two injections. Your child's doctor will also tell you whether the injection or injections should be given on the same day once a week or on two different days (3 or 4 days apart) in the same week. Do not inject more or less of your child's dose without discussion with and advice from your child's doctor. If your child's doctor instructed you to use one vial of ENBREL solution for more than one dose, YOU SHOULD NOT USE THE SAME NEEDLE AND SYRINGE. The supplied syringe and 27-gauge needle should be used only once.

These instructions will help you learn how to prepare the first of multiple doses from a single vial as well as the additional doses from a previously mixed vial of ENBREL.

Free-hand method - For use in children

Preparing first of multiple doses of ENBREL from ENBREL vial.

STEP 1

Setting up for an injection

• Select a clean, well-lit, flat working surface, such as a table.
• Take the ENBREL dose tray out of the refrigerator (2°C to 8°C) and place it on your flat working surface. You may also store the unopened dose tray at room temperature, up to 27°C for up to 60 days. Do NOT freeze. If you have any questions about storage, contact your doctor, nurse or pharmacist for further instructions.
• Wash your hands thoroughly with soap and warm water.
• Peel the paper seal off the dose tray, and remove the contents.

Review contents of dose tray

• The dose tray should contain the items listed below. Use only these items.
• The prefilled diluent syringe is specially designed for the preparation and administration of ENBREL. Do NOT use any other syringe.
• One prefilled diluent syringe containing 1 mL of liquid diluents, with attached twist-off cap
• One plunger
• One ENBREL vial
• One 27-gauge needle in hard plastic cover
• You will also need to use a 25-gauge needle (not supplied) to assist with mixing the powder with the liquid.

If any of the items are missing or if any item looks damaged, do NOT use any of the components and consult your pharmacist or call 1.877.9ENBREL (1.877.936.2735), weekdays 8:00 am to 8:00 pm EST.

Alcohol swabs will also be required for injections and will need to be obtained or purchased separately.

To order alcohol swabs, call Enliven at 1.877.9ENBREL (1.877.936.2735), weekdays 8:00 am to 8:00 pm EST.

Check expiration date

• Inspect the expiration (Exp.) dates on both the ENBREL vial label and prefilled diluent syringe label.
• The dates should be the current month and year or later.
• If the expiration date has passed, or if the unopened dose tray has been stored at room temperature beyond 60 days (whichever comes first), do NOT use the ENBREL vial or prefilled diluent syringe. Contact your pharmacist or call 1.877.9ENBREL (1.877.936.2735) for assistance.

Check volume

• Inspect the volume of diluent in the syringe with the twist-off cap pointing down.
• Use the unit markings on the side of the syringe to make sure there is at least 1 mL of liquid in the syringe.
• Do NOT use the diluent syringe if the level of liquid is below the 1 mL mark or appears to be cracked or broken. Call 1.877.9ENBREL (1.877.936.2735) for assistance, weekdays 8:00 am to 8:00 pm EST.
• Do NOT use if the twist-off cap is missing or not securely attached. Call 1.877.9ENBREL (1.877.936.2735), weekdays 8:00 am to 8:00 pm EST.

STEP 2

Preparing the ENBREL solution

If you are preparing the first dose from an ENBREL vial, follow the steps listed below. If you are preparing a dose from an ENBREL vial that was previously used, click here for instructions.

Remove vial cap

• Remove the pink plastic cap from the ENBREL vial.
• Do NOT remove the grey stopper or silver metal ring around the top of the vial.
• Write the mixing date on the supplied "Mixing Date:" sticker and attach it to the ENBREL vial.

Clean stopper

• Clean stopper
• After cleaning, place the ENBREL vial upright on a flat working surface.
• Do NOT touch the stopper with your hands.

Open needle package

• Partially open (only open part of) the package that contains the 25-gauge needle by peeling apart the tabs, and set aside.
• The 25-gauge needle will be used to mix the liquid with the powder and for withdrawing ENBREL from the vial.

Attach plunger

• Slide the plunger into the flange end of the syringe, turning clockwise three times or until the plunger is attached to the grey stopper in the syringe.

Remove twist-off cap

• Remove the twist-off cap from the prefilled diluent syringe by turning counter-clockwise.
• Do NOT bump or touch the plunger; doing so could cause the liquid to leak out.
• You may see a drop of liquid when removing the twist-off cap — this is normal.

Attach 25-gauge needle to syringe

• With the needle cover still on, in the partially opened paper packaging, twist the 25-gauge needle onto the syringe until it fits snugly.
• Place the syringe on your flat work surface.

Prepare 27-gauge needle

• Prepare the 27-gauge needle by partially opening (only open part of) the package by peeling back the tabs; and set aside for later use.
• The 27-gauge needle will be used to inject ENBREL once the powder is mixed with the liquid.

Reminder: the 25-gauge needle is for mixing and withdrawing ENBREL. The 27-gauge needle is for injecting ENBREL.

Remove needle cover

• Pick up the syringe from your flat work surface.
• Hold the barrel of the syringe with one hand and remove the paper packaging off the 25-gauge needle. Pull the hard plastic needle cover straight. To avoid damaging the needle, do NOT twist or bend the needle cover while you are removing it.
• Do NOT touch the needle or allow it to touch any surface. Do NOT touch or bump the plunger; doing so could cause the solution to leak out. Place the hard plastic needle cover (open side up) in the round space marked "N" in the ENBREL dose tray.

Insert needle into vial

• Place the ENBREL vial upright on the flat working surface.
• Hold the syringe with the needle facing up, and gently pull back on the plunger to pull a small amount of air into the syringe.
• Insert the needle straight down through the centre ring of the grey stopper.
• If the needle is correctly lined up, you should feel a slight resistance and then a "pop" as the needle goes through the centre of the stopper.
• Look for the needle tip inside the stopper window.
• If the needle is not correctly lined up with the centre of the stopper, you will feel a constant resistance as it goes through the stopper and no "pop".
• The needle may enter at an angle and bend, break or prevent proper addition of the diluent into the ENBREL vial.

Press down on plunger

• Push the plunger down VERY SLOWLY until all liquid from the syringe is in the ENBREL vial.
• Adding the liquid too fast will cause foaming (bubbles).

Dissolve powder

• Leave the syringe in place.
• Gently swirl the ENBREL vial between fingers in a circular motion to dissolve the powder. Do NOT SHAKE.
• Wait until all the powder dissolves (usually less than 10 minutes).
• The solution should be clear and colourless. After the powder has completely dissolved, foam (bubbles) may still be present. This is normal.
• Do NOT inject the solution if it is cloudy or discoloured or if it contains large coloured particles.
• If all the powder in the ENBREL vial is not dissolved or there are particles present after 10 minutes, call 1.877.9ENBREL (1.877.936.2735) for assistance, weekdays 8:00 am to 8:00 pm EST.

DO NOT WITHDRAW ENBREL SOLUTION INTO THE SYRINGE UNTIL YOU ARE READY TO INJECT.

Withdraw ENBREL from vial

• With the needle still in the vial, turn the vial upside down.
• Push the plunger all the way in to remove air from the syringe.
• Holding the syringe at eye level, slowly pull the plunger back to the mark on the side of the syringe that corresponds with the correct dose.
• Remove only the portion of the solution as instructed by your child's doctor.
• As the solution level drops in the vial, you may need to partially withdraw the needle to keep the tip of the needle in the solution.
• Be careful not to pull the plunger completely out of the syringe.
• Some white foam may remain in the vial - this is normal.

Check for bubbles

• With the needle still inserted in the vial, check for air bubbles in the syringe.
• Gently tap the syringe to make any bubbles rise to the top of the syringe.
• Slowly push the plunger up to remove the air bubbles.
• If you push solution back into the vial, slowly pull back on the plunger to draw the correct amount of solution back into the syringe.

Remove syringe and needle from vial

• Remove the syringe and needle from the ENBREL vial.
• Again, do NOT touch the needle or allow it to touch any surface.
• Place the 25-gauge needle back into the hard plastic needle cover in the ENBREL dose tray, and push the syringe down until the needle is attached.
• Once the needle is secure in the needle cover, untwist the 25-gauge needle from the syringe and dispose of the needle in your sharps disposal container.

Attach 27-gauge needle to syringe

• With the needle cover still on, in the partially opened paper packaging, twist the new 27-gauge needle onto the syringe until it fits snugly.
• Remove the paper packaging from the needle cover.
• Do NOT remove the needle cover from the syringe until you are ready to inject.
• Pull the hard plastic needle cover straight off the syringe.
• To avoid damaging the needle, do NOT twist or bend the needle cover while you are removing it and do NOT try to put the needle cover back onto the syringe. When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal.
• Do NOT touch the needle or allow it to touch any surface.
• You are now ready to inject ENBREL.

Click here for instructions on Choosing and Preparing an Injection Site.

Free-hand method - For use in children

Preparing additional doses of ENBREL from multiple-use vials

For some children, one vial of ENBREL solution can be used for more than one dose. Your child's doctor will tell you if this is the case for your child. Contents of one vial of ENBREL solution should not be mixed with, or transferred into, the contents of another vial of ENBREL.

If you are preparing a dose from a vial that was previously used, follow the instructions below. Do NOT re-use needles or syringes supplied with your ENBREL.

Prepare components

• Select a clean, well-lit, flat working surface, such as a table.
• Your doctor will tell you what type of syringe and needles (1 mL Luer-lok® syringe, and 25- and 27-gauge needles) to use.
• Alcohol swabs are available at a drugstore.
• Place the new empty sterile syringe with a 25-gauge needle (for withdrawing ENBREL), a 27-gauge needle (for injecting ENBREL) and two alcohol swabs on your flat working surface.

To order alcohol swabs, call Enliven at 1.877.9ENBREL (1.877.936.2735), weekdays 8:00 am to 8:00 pm EST.

Check date

• Take the vial of ENBREL solution that is stored in the dose tray out of the refrigerator and place it on your flat working surface. For a more comfortable injection, allow ENBREL to reach room temperature (approximately 15 to 30 minutes).
• Check the mixing date you wrote on the sticker on the ENBREL vial and confirm that the mixed solution is less than 14 days old. Do NOT inject the solution if it is cloudy or discoloured, or if it contains large or coloured particles. Discard the vial if more than 14 days have passed since the ENBREL solution was mixed.

Wash hands

• Wash your hands with soap and warm water.

Clean stopper

• Use one alcohol swab to clean the grey stopper on the ENBREL vial.
• Do NOT touch the stopper with your hands.

Prepare 25-gauge needle and syringe

• If the syringe and the 25-gauge needle are not pre-assembled, assemble them as instructed by your doctor.

Prepare 27-gauge needle

• Prepare the 27-gauge needle by partially opening (only open part of) the package by peeling back the tabs.
• Set the 27-gauge needle aside. The 27-gauge needle will be used to inject the dose of ENBREL.

Reminder: the 25-gauge needle is for mixing and withdrawing ENBREL. The 27-gauge needle is for injecting ENBREL.

Remove needle cover

• Pick up the syringe from your flat work surface.
• Hold the syringe and pull the hard plastic needle cover straight off. To avoid damaging the needle, do NOT twist or bend the needle cover while you are removing it.
• Do NOT touch the needle or allow it to touch any surface. Place the hard plastic needle cover (open side up) in the round space of the ENBREL dose tray marked "N".

Insert needle into vial

• Place the ENBREL vial upright on the flat working surface.
• Hold the syringe with the needle facing up, and gently pull back on the plunger to pull a small amount of air into the syringe.
• Insert the 25-gauge needle straight down through the centre ring of the grey stopper.
• If the needle is correctly lined up, you should feel a slight resistance and then a "pop" as the needle goes through the centre of the stopper.
• Look for the needle tip inside the stopper window.
• If the needle is not correctly lined up with the centre of the stopper, you will not feel a "pop" and will feel constant resistance as you push the needle through the stopper.
• If you do not line the needle up correctly, it may enter at an angle and bend, break or prevent proper withdrawal of ENBREL solution from the vial.

Withdraw ENBREL

• With the needle still in the vial, turn the vial upside down.
• Holding the syringe at eye level, slowly pull the plunger down to the mark on the syringe that corresponds to your child's dose.
• As the solution level drops in the vial, you may need to partially withdraw the needle to keep the tip of the needle in the solution.

Check for bubbles

• With the needle still inserted in the vial, check for air bubbles in the syringe.
• Gently tap the syringe to make any bubbles rise to the top of the syringe.
• Slowly push the plunger up to remove the air bubbles.
• If you push solution back into the vial, slowly pull back on the plunger to draw the correct amount of solution back into the syringe.

Remove syringe and needle from vial

• Do Not touch the needle or allow it to touch any surface.
• Do Not touch or bump the plunger; doing so could cause the solution to leak out.
• Place the 25-gauge needle back into the hard plastic needle cover in the ENBREL dose tray, and push the syringe down until the needle is attached.
• Once the needle is secure in the needle cover, untwist the 25-gauge needle from the syringe and dispose of the needle in your sharps disposal container.

• With the needle cover still on, in the partially opened paper packaging, twist the new 27-gauge needle onto the syringe until it fits snugly.
• Remove the paper packaging from the needle cover.
• Do NOT remove the needle cover from the syringe until you are ready to inject.
• Pull the hard plastic needle cover straight off the syringe.
• To avoid damaging the needle, do NOT twist or bend the needle cover while you are removing it and do NOT try to put the needle cover back onto the syringe. When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal.
• Do NOT touch the needle or allow it to touch any surface.
• You are now ready to inject ENBREL.