Self-injection & Storage

Safety Information

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HCPs

Welcome

to your PfizerFlex
Patient Support Program for
XELJANZ XR and XELJANZ

I would like to learn how inject with, and store:

The Prefilled Pen
The Prefilled Syringe

FAQ
How to inject with, and store, the prefilled pen

FAQ
How to inject with, and store, the prefilled syringe

INSTRUCTIONS FOR USE (IFU)
Bookmark these instructions – they show step-by-step directions on how to prepare and give an injection.

Storage Information

Store ABRILADA prefilled pen in the refrigerator between 2ºC to 8ºC.
Store ABRILADA prefilled pen in the original carton until use to protect it from direct sunlight.
Do not freeze ABRILADA prefilled pen. Do not use ABRILADA prefilled pen if frozen, even if it has been thawed.
Refrigerated ABRILADA may be used until the expiration date printed on the ABRILADA carton or prefilled pen. Do not use ABRILADA after the expiration date.
If needed, for example when you are traveling, you may also store ABRILADA at room temperature up to 30°C for a single period of up to 30 days. Store ABRILADA in the original carton until use to protect it from direct sunlight.
Throw away ABRILADA if it has been kept at room temperature and not been used within the 30-day period.
Record the date you first remove ABRILADA from the refrigerator in the spaces provided on the ABRILADA prefilled pen carton.
Do not store ABRILADA in extreme heat or cold.
The medicine in ABRILADA should be clear and colorless to very light brown. Do not use a prefilled pen if the liquid is cloudy, discolored, or has flakes or particles in it.
Care should be taken to avoid dropping or crushing the product as it contains a glass syringe.
Single use. Discard unused portion.

Keep ABRILADA, injection supplies, and all other medicines out of the reach and sight of children.

ABRILADA comes in a disposable (throw away) single-use prefilled pen that contains a single dose of medicine.
ABRILADA can be given by a patient, caregiver or healthcare provider.
Do not try to inject ABRILADA yourself until you have read and understood the Instructions for Use. If your/your child’s healthcare provider decides that you or a caregiver may be able to give your/your child injections of ABRILADA at home, you should receive training on the right way to prepare and inject ABRILADA.
It is also important to talk to your/your child’s healthcare provider to be sure you understand the ABRILADA dosing instructions. To help you remember when to inject ABRILADA, you can mark your calendar ahead of time. Call your/your child’s healthcare provider if you have any questions about the right way to inject ABRILADA.

Step 1. Supplies you need

You will need the following supplies for each injection of ABRILADA.
Find a clean, flat surface to place the supplies on.

1 ABRILADA prefilled pen (included inside the carton)
1 alcohol swab (not included in your/your child’s ABRILADA carton)
1 cotton ball or gauze pad (not included in your/your child’s ABRILADA carton)
1 puncture resistant sharps disposal container for pen disposal (not included in your/your child’s ABRILADA carton).
See Step 10 “Dispose of used prefilled pen” at the end of this Instructions for Use.

Step 2. Getting ready

Remove the ABRILADA carton from the refrigerator.
Make sure the name ABRILADA appears on the carton and prefilled pen label.
Take out 1 ABRILADA prefilled pen. Keep the prefilled pen out of direct sunlight. Put the original carton with any unused prefilled pens back in the refrigerator.
Do not use the prefilled pen if:

the prefilled pen or the carton containing the prefilled pen has been dropped
it has been frozen or thawed
it has been kept in direct sunlight
it appears to be damaged
the seals on a new carton are broken
it has been out of the refrigerator for more than 30 days
the expiration date has passed
the liquid is cloudy, discolored or has flakes or particles

For a more comfortable injection, you may leave the prefilled pen at room temperature for 15 to 30 minutes before your injection.
Do not warm ABRILADA in any other way (for example, do not warm it in a microwave or in hot water).
Do not shake the prefilled pen. Shaking can damage your medicine.
Wash your hands with soap and water, and dry completely.
Do not remove the cap until you are ready to inject.

Step 3. Check your/your child’s medicine and expiration date

Look carefully at the medicine in the window.
Make sure the medicine in the prefilled pen is clear and colorless to very light brown and free from flakes or particles.
It is normal to see one or more air bubbles in the window.
Check the expiration date on the prefilled pen label. The location of the expiration date on the prefilled pen label is shown below. Do not use the pen if the expiration date has passed.

If you have any questions about your medicine, please contact your/your child’s healthcare provider or pharmacist.

Step 4. Choose and prepare the injection site

Choose a different site each time you give an injection.

Only use the front of your/your child’s thighs or lower abdomen (belly) as shown. If you choose the abdomen, do not use the area 5 cm around the belly button (navel).
Each new injection should be given at least 3 cm from a site you used before.

Do not inject into bony areas or areas on the skin that are bruised, red, sore (tender) or hard. Avoid injecting into areas with scars or stretch marks.

If you/your child have psoriasis, do not inject directly into any raised, thick, red, or scaly skin patches or lesions on the skin.

Do not inject through clothes.
Wipe the injection site with the alcohol swab.
Allow the injection site to dry. Do not fan or blow on the clean area.
Do not touch this area again before giving the injection.

Step 5. Remove the cap

Twist and pull off the cap.
Throw the cap away into a sharps disposal container. You will not need it again.
Important: Handle the prefilled pen with care to avoid an accidental needle stick injury.
Note: The needle cover stays inside the cap after removal.

Push the prefilled pen firmly against the skin at 90 degrees, as shown in the diagram.
Note: The needle goes into the skin as you push the prefilled pen down. You will only be able to press down the injection button in Step 7 when you are pushing down firmly enough.
Keep the prefilled pen pushed against the skin until Step 9.

Step 6. Insert the needle

Step 7. Inject your medicine

Press the injection button all the way down and you will hear a click. The click means the start of the injection.

Keep holding the prefilled pen firmly against the skin while the orange bar moves across the window. You will hear a 2^nd click.

Wait for at least 5 more seconds after the 2^nd click to make sure you/your child get the full dose of medicine.
Note: If you cannot press down the injection button, it is because you are not pushing the prefilled pen down firmly enough. See the Question and Answer section for more information on what to do if the injection button does not press down.

Step 8. Check the window

You should see an orange bar in the window.
Do not remove the prefilled pen until you have waited at least 5 seconds after the 2^nd click and until the orange bar completely fills the window.

Step 9. Remove the prefilled pen

Remove the prefilled pen from the skin.
Note: After you remove the prefilled pen from the skin, the needle will be automatically covered.
If the window has not turned orange, this means you/your child have not received a full dose. Call your/your child’s healthcare provider or pharmacist right away.
Do not inject another dose.

Step 10. Dispose of used prefilled pen

Do not throw away (dispose of) prefilled pens in your household trash or recycle bin.
Put the used prefilled pen in a puncture resistant sharp disposal container right away after use.
If you do not have a container made especially for this purpose (sharp container), you may use a hard plastic container with a screw-on cap or metal container with a plastic lid labelled “Used Syringes”. Do not use glass or clear plastic containers.
Always keep the container out of the sight and reach of children.
When the container is about two-thirds full, tape the cap or lid down so it does not come off and dispose of it as instructed by your/your child’s doctor, nurse or pharmacist. DO NOT THROW THE CONTAINER IN THE HOUSEHOLD TRASH OR RECYCLING BIN.
You should follow any special provincial or local laws regarding the proper disposal of needles and syringes.

Step 11. After your injection

Look closely at the injection site. If there is blood, use a clean cotton ball or gauze pad to press lightly on the injection area for a few seconds.
Do not rub the injection site.
Note: Store any unused prefilled pens in the refrigerator in the original carton.

Questions and Answers

Is it okay to shake the prefilled pen before I use it?

No, do not shake the prefilled pen. Shaking can damage the medicine. When you check the medicine, gently tilt the prefilled pen back and forth while looking carefully into the window. It is normal to see one or more air bubbles.

What should I do with the prefilled pen if it has been dropped?

Do not use it, even if it looks undamaged. Dispose of the prefilled pen in the same way as a used prefilled pen. You will need to use a new prefilled pen to give you/your child’s injection.

Can I use the prefilled pen straight from the refrigerator?

Yes, however you may find that using the prefilled pen at room temperature reduces stinging or discomfort. If you allow the prefilled pen to reach room temperature before use, you must keep it away from direct sunlight as this can damage your medicine.

What should I do if I need to travel?

When you are travelling, you may store the prefilled syringe in its carton at room temperature up to 30°C for up to 30 days.

Do I need to remove any air bubbles before using the prefilled pen?

No, do not attempt to remove air bubbles.

Drops of medicine have appeared at the needle tip. Is this okay?

Yes, it is normal to see a few drops of medicine at the needle tip when you remove the cap.

Can I re-insert the needle if I change my mind where I want to inject?

No, you should not re-insert the needle into your/your child’s skin. If you change your mind, you will need a replacement prefilled pen if the needle has already been inserted into the skin. After the injection button has been pressed, you must not lift the prefilled pen from the skin until the injection has finished.

I pushed the prefilled pen against the skin but could not press the button down. What should I do?

Take your finger off the injection button and push your prefilled pen down more firmly against the skin. Then try pushing
the button again. If this does not work, stretching the skin may make the injection site firmer, making pressing the injection button easier.

Can I pinch or stretch the skin at the injection area?

Yes, pinching or stretching the skin before injection may make the injection site firmer, making it easier to press the injection button.

Do I need to keep my finger pressed on the injection button for the whole injection?

No, you can stop pressing the button when the injection has started. However, make sure you keep holding the prefilled pen firmly against the skin. The prefilled pen will continue to deliver the medicine.

How long will the injection take?

From the time the dose begins until you hear the 2^nd click, it usually takes 3 to 10 seconds. After the 2^nd click, you should continue to hold your prefilled pen in place for at least 5 more seconds to make sure you give the full dose.

What should I do if I see more than a small drop of medicine on the skin after giving the injection?

Nothing this time, but for your next injection wait a little longer before removing the prefilled pen from the skin to make sure all of the medicine went into your/your child’s skin.