Enbrel Patient Counseling Information

Instructions for preparing and giving an injection of Enbrel: Powder and solvent for injection: Introduction: The following instructions explain how to prepare and inject ENBREL. Read the instructions carefully and follow them step by step. You will be instructed by your doctor or his/her assistant on the techniques of self-injection or on giving an injection to a child. Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
This injection should not be mixed with any other medicine.
Setting Up For An Injection: Wash your hands thoroughly.
Select a clean well-lit, flat working surface.
The dose tray should contain the items listed as follows. (If not, don't use the dose tray and consult your pharmacist). Use only the items listed. DO NOT use any other syringe.
1 ENBREL vial; 1 Pre-filled syringe containing clear, colourless solvent (water for injections); 1 Needle; 1 Vial adaptor; 2 Alcohol swabs.
Inspect the expiry dates on both the vial label and the syringe label. They should not be used after the month and year shown.
Preparing the ENBREL Dose for Injection: Remove the contents of the tray.
Remove the plastic cap from the ENBREL vial. DO NOT remove the grey stopper of or aluminium ring around the top of the vial.
Use a new alcohol swab to clean the grey stopper on the ENBREL vial. After cleaning, do not touch the stopper with your hands or allow it to touch any surface.
Place the vial upright on a clean, flat surface.
Remove the paper backing from the vial adaptor package.
While still in the plastic package, place the vial adaptor on top of the ENBREL vial so that the vial adaptor spike is centered within the raised circle on top of the vial stopper.
Hold the vial firmly on the flat surface with one hand. With the other hand, push STRAIGHT DOWN FIRMLY on the adaptor package until you feel the adaptor spike penetrate the vial stopper and FEEL AND HEAR THE ADAPTOR RIM LOCK INTO PLACE. DO NOT push down the adaptor at an angle. It is important that the vial adaptor spike completely penetrates the vial stopper.
While still holding the vial in one hand, remove the plastic packaging from the vial adaptor.
Remove the protective cover from the syringe tip by breaking the white cap along the perforation. This is done by holding the collar of the white cap while grasping the end of the white cap with the other hand and bending it down and then up until it is broken. DO NOT remove the white collar that remains on the syringe.
Do not use the syringe if this perforation is already broken. Start again with another dose tray.
Holding the glass barrel of the syringe (not the white collar) in one hand, and the vial adaptor (not the vial) in the other, connect the syringe to the vial adaptor by inserting the tip into the opening and turn clockwise until completely secured.
Adding Solvent: While holding the vial upright on the flat surface, push the plunger VERY SLOWLY until all the solvent is in the vial. This will help to reduce foaming (lots of bubbles).
Once the solvent is added to the ENBREL, the plunger may move up by itself. This is due to air pressure and should not be of concern.
With the syringe still attached, gently move the vial in circles a few times, to dissolve the powder. DO NOT shake the vial. Wait until all the powder dissolves (usually less than 10 minutes). The solution should be clear to slightly opalescent and colourless to slightly yellow or pale brown. DO NOT use ENBREL if all the powder in the vial is not dissolved within 10 minutes. Start again with another dose tray.
Withdrawing the ENBREL Solution From the Vial: With the syringe still attached to the vial and vial adaptor, hold the vial upside down at eye level. Push the plunger all the way into the syringe.
Then, slowly pull the plunger back to draw the liquid into the syringe. Unless otherwise instructed by your physician, withdraw the entire volume. For children, remove only the portion of liquid as directed by your child's doctor. After you have withdrawn the ENBREL from the vial, you may have some air in the syringe. Do not be concerned, as you will remove the air in a later step.
With the vial held upside down, unscrew the syringe from the vial adaptor by turning it anti-clockwise.
Place the filled syringe on the clean, flat surface. Make sure that the tip does not touch anything. Be careful not to push down on the plunger. (Note: After you have completed these steps, a small amount of liquid may remain in the vial. This is normal.)
Placing the Needle on the Syringe: The needle has been placed in a plastic container to keep it sterile.
To open the plastic container, hold the short, wide end in one hand. Place your other hand on the longer portion of the container.
To break the seal, bend the larger end down and then up until broken.
Once the seal has been broken, remove the short, wide end of the plastic container.
The needle will remain in the long part of the package.
While holding the needle and container in one hand, pick up the syringe and insert the syringe tip into the needle opening.
Attach the syringe to the needle by turning it clockwise until completely secured.
Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces. Be careful not to bend or twist the cover during removal to avoid damage to the needle.
While holding the syringe upright, remove any air bubbles by slowly pushing on the plunger until the air is removed.
Choosing an Injection Site: Three recommended injection sites for ENBREL include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms. If you are self-injecting, you should not use the outer area of the upper arms.
A different site should be used for each new injection. Each new injection should be given at least 3 cm from an old site. DO NOT inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. (It may be helpful to keep notes on the location of the previous injections.)
If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches ("psoriasis skin lesions").
Preparing the injection site and injecting the ENBREL Solution: Wipe the site where ENBREL is to be injected with an alcohol swab, using a circular motion. DO NOT touch this area again before giving the injection.
When the cleaned area of skin has dried, gently pinch the sides of the cleaned area of skin with one hand and hold firmly. With the other hand, hold the syringe like a pencil. Be careful not to touch the cleaned area.
With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90°. With experience, you will find the angle that is most comfortable for you. Be careful not to push the needle into the skin too slowly, or with great force.
When the needle is completely inserted into the skin, release the skin that you are holding.
With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate.
When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted. There may be a little bleeding at the injection site.
You can press a cotton ball or gauze over the injection site for 10 seconds. DO NOT rub the injection site. If needed, you may cover the injection site with a bandage.
Disposing of Supplies: The syringe and needles should NEVER be reused. Dispose of the needles and syringe as instructed by your doctor, nurse or pharmacist.
If you have any questions, talk to a doctor, nurse or pharmacist who is familiar with ENBREL.
Solution for injection in pre-filled syringe: Introduction: The following instructions explain how to prepare and inject ENBREL. Read the instructions carefully and follow them step by step. You will be instructed by your doctor or his/her assistant on the techniques of self-injection or on giving an injection to a child. Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
The ENBREL solution should not be mixed with any other medicine before use.
Step 1: Setting Up For An Injection: 1. Select a clean, well-lit, flat working surface.
2. Take the ENBREL carton containing the pre-filled syringes out of the refrigerator and place it on the flat work surface. Starting from one of the top corners, pull back the paper cover from the top and sides of the tray. Remove one pre-filled syringe and one alcohol swab and place them on the work surface. Do not shake the pre-filled syringe of ENBREL. Place the carton containing any remaining pre-filled syringes back into the refrigerator (2° to 8°C). If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
3. Check the expiration date on the pre-filled syringe. If the expiration date has passed, do not use the pre-filled syringe and contact your pharmacist for assistance.
4. You should allow 15 to 30 minutes for the ENBREL solution in the syringe to reach room temperature. DO NOT remove the needle cover while allowing it to reach room temperature. Waiting until the solution reaches room temperature may make the injection more comfortable for you. Do not warm ENBREL in any other way (for example, do not warm it in a microwave or in hot water).
5. Assemble the additional supplies you will need for your injection. These include the alcohol swab from the Enbrel carton, and a cotton ball or gauze.
6. Wash your hands with soap and warm water.
7. Inspect the solution in the pre-filled syringe. It should be clear to opalescent, colourless to yellow or pale brown, and may contain small white or almost transparent particles of protein. This appearance is normal for ENBREL. Do not use the solution if it is discoloured, cloudy, or if particles other than those described previously are present. If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Step 2: Choosing An Injection Site: 1. Three recommended injection sites for ENBREL using a pre-filled syringe include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms. If you are self-injecting, you should not use the outer area of the upper arms.
2. A different site should be used for each new injection. Each new injection should be given at least 3 cm from an old site. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. (It may be helpful to keep notes on the location of the previous injections.)
3. If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches ("psoriasis skin lesions").
Step 3: Injecting the ENBREL Solution: 1. Wipe the site where ENBREL is to be injected with an alcohol swab, using a circular motion. DO NOT touch this area again before giving the injection.
2. Pick up the pre-filled syringe from your flat work surface. Remove the needle cover by firmly pulling it straight off the syringe. Be careful not to bend or twist the cover during removal to avoid damage to the needle. 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. Do not touch or bump the plunger. Doing so could cause the liquid to leak out.
3. When the cleaned area of skin has dried, pinch and hold it firmly with one hand. With the other hand, hold the syringe like a pencil.
4. With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90°. With experience, you will find the angle that is most comfortable for you. Be careful not to push the needle into the skin too slowly, or with great force.
5. When the needle is completely inserted into the skin, let go of the skin that you are holding. With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate.
6. When the syringe is empty, pull the needle out of the skin, being careful to keep it at the same angle as inserted. There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site for 10 seconds. DO NOT rub the injection site. If needed, you may cover the injection site with a bandage.
Step 4: Disposing of Supplies: 1. The pre-filled syringe is for single-use administration only. The syringe and needle should NEVER be reused. NEVER recap a needle. Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist.
If you have any questions, talk to a doctor, nurse or pharmacist who is familiar with ENBREL.