Skyrizi Patient Counseling Information

Instructions for use: Important information to know before you inject Skyrizi: You should receive training on how to inject Skyrizi before giving an injection. Talk to your doctor, pharmacist or nurse if you need help.
Mark the dates on your calendar so you know when to inject Skyrizi.
Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it.
Do not inject if the liquid in the inspection window is cloudy or contains flakes or large particles. The liquid should look clear to yellow and may contain tiny white or clear particles.
Do not shake the pen, carton, cartridge or on-body injector.
150 mg: Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 30 to 90 minutes before injecting.
Wait to remove the dark grey cap until just before the injection.
Return this medicine to the pharmacy: if the expiry date (EXP) has passed; if the liquid has ever been frozen (even if thawed); if the pen has been dropped or damaged; if the carton perforations are broken.
360 mg: The single use on-body injector is designed for use with Skyrizi cartridge only.
Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for at least 45 up to 90 minutes before injecting.
Do not let the on-body injector get wet with water or any other liquids.
Do not touch the start button until you place the on-body injector loaded with the cartridge onto your skin and are ready to inject: You can only press the start button one time.
Physical activity should be limited during the injection process. Moderate physical activities can be done, such as walking, reaching and bending.
Do not delay in injecting the medicine after loading the cleaned cartridge into the on-body injector. Waiting will dry out the medicine and the on-body injector will not work afterwards.
Do not re-use the cartridge or the on-body injector.
Return this medicine to the pharmacy: if the expiry date (EXP) has passed; if the liquid has ever been frozen (even if thawed); if the cartridge or on-body injector has been dropped or damaged; if the carton perforations are broken; if the white paper tray cover is broken or missing.
Follow the steps as follows each time you use Skyrizi: 150 mg: STEP 1: Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 30 to 90 minutes before injecting. Do not remove the pen from the carton while allowing Skyrizi to reach room temperature. Do not warm Skyrizi in any other way. For example, do not warm it in a microwave or in hot water. Do not use the pen if liquid has been frozen, even if it has been thawed.
STEP 2: Place the following items on a clean, flat surface: 1pre-filled pen; 1 alcohol pad (not included in the carton); 1 cotton ball or gauze pad (not included in the carton); special disposal container (not included in the carton).
Wash and dry your hands.
STEP 3: Choose from these 3 areas to inject: front of left thigh; front of right thigh; your belly (abdomen) at least 5 cm from your belly button (navel).
Before the injection, wipe where you will inject in a circular motion with an alcohol pad. Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before injecting. Do not inject through clothes. Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks. Do not inject into areas affected by psoriasis.
STEP 4: Hold the pen with the dark grey cap pointing up. Pull the dark grey cap straight off. Throw the dark grey cap away.
Check the liquid through the inspection window. It is normal to see bubbles in the liquid. The liquid should look clear to yellow and may contain tiny white or clear particles. Do not use if the liquid is cloudy or contains flakes or large particles.
STEP 5: Hold the pen with your fingers on the grey hand grips.
Turn the pen so that the white needle sleeve points toward the injection site and you can see the green activator button.
Gently squeeze the skin at your injection site to make a raised area and hold it firmly.
Place the white needle sleeve straight (90° angle) against the raised injection site.
STEP 6: Hold the pen so that you can see the green activator button and inspection window.
Push and keep pressing the pen down against the raised injection site. The pen will activate only if the white needle sleeve is pressed down against the injection site before pressing the green activator button.
Press the green activator button and hold the pen for 15 seconds. A loud "click" means the start of the injection.
STEP 7: Keep pressing the pen down against the injection site.
The injection is complete when: the pen has made a second "click" or; the yellow indicator has filled the inspection window.
This takes up to 15 seconds.
STEP 8: When the injection is complete, slowly pull the pen out from the skin.
The white needle sleeve will cover the needle tip and make another "click".
After completing the injection, place a cotton ball or gauze pad on the skin at the injection site. Do not rub the injection site. Slight bleeding at the injection site is normal.
STEP 9: Throw away the used pen in a special disposal container straight after use. Do not throw away the used pen in the household waste. Your doctor, pharmacist or nurse will tell you how to return the full special disposal container.
360 mg: STEP 1: Get ready. Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for at least 45 up to 90 minutes before injecting. Check expiry date (EXP) on the carton. Do not use Skyrizi if the expiry date (EXP) has passed. Do not remove the cartridge or on-body injector from the carton while allowing Skyrizi to reach room temperature. Do not warm Skyrizi in any other way. For example, do not warm it in a microwave or in hot water.
Gather all supplies and wash your hands. Place the following items on a clean, flat surface: plastic tray containing 1 on-body injector and 1 cartridge; 2 alcohol pads (not included in the carton); 1 cotton ball or gauze pad (not included in the carton); special disposal container (not included in the carton).
Wash and dry your hands.
Remove the white paper tray seal. Locate the black arrow. Peel away the white paper tray seal from the plastic tray.
Lift the plastic cover. Locate the rounded opening on the top cover. Insert your index finger in the opening and place your thumb on the opposite side. Lift the cover to remove and set it aside.
Inspect the on-body injector. Check that the on-body injector is intact and not damaged. The grey door should be slightly open. If the grey door does not open, press in firmly on the grey door ridges (left side of door) and swing open the door. Do not close the grey door before the cartridge is loaded. Do not use on-body injector if you drop it, discover missing pieces, or if it's damaged. Do not touch the grey start button until it is time to inject. It can be pressed one time only. Do not touch the needle cover area or needle.
If the grey start button is pressed before placing it on your body, the on-body injector can no longer be used. If this happens, speak to your doctor, pharmacist or nurse.
STEP 2: Set up on-body injector. Fully open the grey door. Avoid touching the needle cover area on the back of the on-body injector. The needle is behind the needle cover. Swing the grey door all the way to the right to open it. If the grey door does not open, press in firmly on the grey door ridges (left side of door) and swing open the door. Do not close the grey door before the cartridge is loaded.
Put the on-body injector aside.
Inspect the cartridge. Carefully remove the cartridge from the plastic tray. Do not twist or remove cartridge top.
Check the cartridge. The liquid should look clear to yellow and may contain tiny white or clear particles. It is normal to see one or more bubbles. Do not use if the liquid is cloudy, discoloured, or contains flakes or large particles. The cartridge parts and the clear plastic are not cracked or broken. Do not use if the liquid has been frozen (even if thawed). Do not use the cartridge if you drop it, discover missing pieces, or it is damaged.
Clean the smaller bottom tip of the cartridge. Locate the smaller bottom tip of the cartridge. Clean smaller bottom tip of the cartridge with an alcohol pad. Make sure to use the alcohol pad to clean the centre of the smaller bottom tip of the cartridge. Do not touch the smaller bottom tip of the cartridge after cleaning.
Load the cleaned cartridge into the on-body injector. Do not twist or remove the cartridge top. Insert the smaller bottom tip of the cartridge into the on-body injector first.
Firmly push down on the cartridge top until you hear a "click". After loading the cartridge, you may see a few drops of medicine on the back of the on-body injector. This is normal.
Make sure to proceed to the next step without delay. Waiting will dry out the medicine.
Close the grey door. Swing the grey door to the left, then squeeze firmly and listen for the grey door to "snap" shut. The grey door should stay locked after loading the cartridge. Do not close the grey door if the cartridge is not fully inserted or is missing. Proceed without delay to the next step.
STEP 3: Prepare to inject. Choose and clean your injection site. Choose from these 3 areas to inject: front of left thigh; front of right thigh; your belly (abdomen) at least 5 cm from your belly button (navel).
Do not inject into areas of the skin that naturally fold or bulge because the on-body injector could fall off during wear.
Before the injection, wipe where you will inject in a circular motion with an alcohol pad. Do not touch or blow on the injection site after it is cleaned. Allow the skin to dry before placing the on-body injector on the skin. Do not inject through clothes. Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks, moles or excessive hair. You can trim the excessive hair from the injection site.
Peel both tabs to expose skin adhesive. Turn the on-body injector over to find both green pull tabs. Avoid touching the needle cover (needle inside).
Peel away the large section using the green pull tab to expose the skin adhesive.
Peel away the small section using the green pull tab to expose the skin adhesive. This will remove the clear plastic strip, activating the on-body injector.
Check the status light when the on-body injector beeps. The status light will flash blue when the on-body injector is activated. If the status light does not flash blue, speak to your doctor, pharmacist or nurse. Do not press the grey start button yet. Do not touch the needle cover or the needle. Do not pull the adhesive material off on-body injector or allow the sticky side to fold and stick to itself.
The Skyrizi on-body injector must be placed on the skin and injection must be started within 30 minutes after removing the green pull tabs or it will not work. Make sure to proceed to next step without delay.
If the status light flashes red, the on-body injector is not working properly. Do not continue to use it. Speak to your doctor, pharmacist or nurse for assistance. If the on-body injector is attached to your body, carefully remove it from your skin.
Prepare the on-body injector for placement. For the belly (abdomen), move and hold the skin to create a firm, flat surface for injection at least 5 cm from your belly button (navel). Make sure to sit up straight to avoid skin folds and bulges. You do not need to pull the skin flat for the front of left thigh or right thigh.
Make sure to place the on-body injector so that you can see the blue status light.
Place the on-body injector on your skin. When the blue light flashes, the on-body injector is ready. Place the on-body injector onto the cleaned skin with the status light visible. Do not place the on-body injector on clothes. Only place on bare skin. Run your finger around the adhesive material to secure it. Do not move or adjust the on-body injector after it has been placed on your skin.
Proceed without delay to the next step.
STEP 4: Inject Skyrizi. Start injection. Firmly press and release the grey start button. You will hear a "click" and may feel a needle pinch. Check the status light when the on-body injector beeps. After starting the injection, the status light will continuously flash green. After starting the injection, you will hear pumping sounds as the on-body injector delivers the medicine.
Do not continue to use the on-body injector if status light flashes red. Carefully remove from skin if the status light flashes red. If this happens, speak to your doctor, pharmacist or nurse.
Wait for the injection to finish. It may take up to 5 minutes to complete the full dose of medicine. The on-body injector will automatically stop when the injection is finished. During the injection, the status light will continue to flash green. During the injection, you will hear pumping sounds as the on-body injector continues delivering the medicine.
During the injection, moderate physical activities can be done, such as walking, reaching and bending.
Do not continue to use the on-body injector if the status light flashes red. Carefully remove it from the skin if the status light flashes red. If this happens, speak to your doctor, pharmacist or nurse.
Injection is complete when: The on-body injector stops on its own. You hear a beep and the status light changes to solid green. If the status light has changed to solid green, this means that the injection is complete.
Remove the on-body injector. Do not put your fingers on the back side of the on-body injector when removing it from your skin. When the injection is done, grab the corner of the adhesive to carefully peel the on-body injector from the skin. Avoid touching the needle cover or needle on the back of the on-body injector. After removing the on-body injector, you will hear several beeps and the status light will turn off. The needle cover will cover the needle when the on-body injector is removed from the skin. It is normal to see a few small drops of liquid on your skin after removing the on-body injector. Press a cotton ball or gauze pad over the injection site on your skin and hold for 10 seconds. Do not rub the injection site. Slight bleeding at the injection site is normal.
Proceed to the next step.
STEP 5: Finish. Check the on-body injector. Inspect the medicine window and status light.
Check to see that the white plunger fills the entire medicine window and the solid green light turns off, letting you know that all the medicine has been injected. If the white plunger does not fill the window, speak to your doctor, pharmacist or nurse.
Disposal: Throw away the used on-body injector in a special disposal container straight after use. The on-body injector contains batteries, electronics, and a needle. Leave the cartridge in the on-body injector. Do not throw away the used on-body injector in the household waste. Your doctor, pharmacist or nurse will tell you how to return the full special disposal container. There may be local guidelines for disposal.