INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF

PLD Reference: ENB-SIN-0918/PIL/0

Date of Last Revision: 05 September 2018

Country: Singapore

Reference document: CDS version 43 Effective date 13 April 2018

Reason for change: to align with LPD update due to CMC change in CDS version 43

ENB-SIN-0918/PIL/0

Date of last revision: September 2018 1

INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF ENBREL

(SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE)

This section is divided into the following subsections:

Introduction

Step 1: Setting up for an injection

Step 2: Choosing an injection site

Step 3: Injecting the ENBREL solution

Step 4: Disposing of supplies

Introduction

The following instructions explain how to prepare and inject ENBREL. Please 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 etanercept 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. 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,

colorless 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 discolored, cloudy, or if particles other than those described above are present.

If you are concerned with the appearance of the solution, then contact your pharmacist

for assistance.

PLD Reference: ENB-SIN-0918/PIL/0

Date of Last Revision: 05 September 2018

Country: Singapore

Reference document: CDS version 43 Effective date 13 April 2018

Reason for change: to align with LPD update due to CMC change in CDS version 43

ENB-SIN-0918/PIL/0

Date of last revision: September 2018 2

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 (see Diagram 1). If

you are self-injecting, you should not use the outer area of the upper arms.

Diagram 1

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.

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 (see Diagram 2). 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.

Diagram 2

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.

PLD Reference: ENB-SIN-0918/PIL/0

Date of Last Revision: 05 September 2018

Country: Singapore

Reference document: CDS version 43 Effective date 13 April 2018

Reason for change: to align with LPD update due to CMC change in CDS version 43

ENB-SIN-0918/PIL/0

Date of last revision: September 2018 3

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 (see Diagram 3). Be careful not to push the needle into the skin

too slowly, or with great force.

Diagram 3

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 stabilize it.

Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram

4).

Diagram 4

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, please talk to a doctor, nurse or pharmacist who is familiar

with ENBREL.

ENB-SIN-0918/PIL/0

Date of last revision: September 2018