Vial Adapter Method - For Single Use Only

The vial adapter method is for single-use administration of ENBREL. The following instructions are for preparing and giving a dose of ENBREL using this method. For your convenience, the vial adapter device is available to help you mix the powder with the liquid, withdraw ENBREL, and then use a 27-gauge needle to inject the dose. This method is only for adult patients and children who use an entire vial of ENBREL for each injection. This method should not be used for children withdrawing multiple doses from the same vial of ENBREL.

Ask your doctor or your child's doctor if you have questions about which method to use.

These instructions will help you learn how to prepare and give a dose of ENBREL using the vial adapter method for single use only.

Vial adapter method – For single use only

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
• One vial adapter

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.

Do NOT use the syringe 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.

Check expiration date

• Inspect the expiration (Exp.) dates on both the ENBREL vial label and prefilled diluents 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, weekdays 8:00 am to 8:00 pm EST.

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 1mL 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.

STEP 2

Preparing the ENBREL solution

• Remove the pink plastic cap from the ENBREL vial.
• Do NOT remove the grey stopper or silver metal ring around the top of the ENBREL vial.

Clean stopper

• Place your ENBREL vial on a flat working surface or turn your dose tray upside down and place your ENBREL vial in the round space marked "V".
• Use one alcohol swab to clean the grey stopper on the ENBREL vial.
• Do NOT touch the stopper with your hands.

Open packages for needle and vial adapter

• Partially open (only open part of) the package that contains the 27-gauge needle by peeling apart the tabs, and set aside.
• Open the package with the vial adapter by peeling apart the tabs. Do NOT touch the vial adapter's twist-on end or the spike inside.

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 vial adapter to vial

• Hold your ENBREL vial upright on your flat work surface.
• Grasp the sides of the vial adapter and place it over the top of the ENBREL vial.
• Do NOT bump or touch the plunger; doing so could cause the liquid to leak out.
• Press down until the vial adapter attaches to the ENBREL vial.
• The plastic spike inside the vial adapter should puncture the grey stopper.
• The vial adapter should fit snugly.

Press down on plunger

• Once the vial adapter is attached to the vial, hold the ENBREL vial upright on your flat work surface and, press the plunger down until all the liquid from the syringe is in the ENBREL vial.
• You may see foaming (bubbles) in the vial - this is normal.

Dissolve powder

• Gently swirl the ENBREL vial between fingers in a circular motion to dissolve the powder.
• If you used the dose tray to hold your ENBREL vial, take the vial (with the vial adapter and syringe still attached) out of the dose tray, and gently swirl 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 or 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 THE ENBREL SOLUTION INTO THE SYRINGE UNTIL YOU ARE READY TO INJECT.

Withdraw ENBREL from vial

• With the vial adapter and syringe attached to the vial of ENBREL, turn the ENBREL 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 down to remove the entire volume (1 mL), unless otherwise instructed by your doctor.
• Be careful not to pull the plunger completely out of the syringe.
• Some white foam may remain in the ENBREL vial - this is normal.

Check for bubbles

• Check for air bubbles in the syringe.
• Gently tap the syringe to make any air 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 vial adapter

• To remove the syringe from the vial adapter, grasp the vial adapter with one hand and untwist the syringe with the other hand.
• Do NOT touch or bump the plunger; doing so could cause the solution to leak out.

Attach 27-gauge needle to syringe

• Place the ENBREL vial with the vial adapter on your flat work surface.
• 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.
• When you are ready to inject, pull the hard plastic needle cover straight off the syringe.
• 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.