Repatha Patient Counseling Information

Instructions for use: Evolocumab (Repatha) single use SureClick pre-filled autoinjector: Important: Needle is inside the yellow safety guard.
Before you use the Evolocumab (Repatha) pre-filled autoinjector, read this important information: Do not freeze or use the Evolocumab (Repatha) pre-filled autoinjector if it has been frozen.
Do not remove the orange cap from the Evolocumab (Repatha) pre-filled autoinjector until you are ready to inject.
Do not use the Evolocumab (Repatha) pre-filled autoinjector if it has been dropped on a hard surface. Part of the Evolocumab (Repatha) pre-filled autoinjector may be broken even if you cannot see the break.
Step 1: Prepare.
Remove one Evolocumab (Repatha) pre-filled autoinjector from the package.
1. Carefully lift the pre-filled autoinjector straight up out of the box.
2. Put the original package with any unused pre-filled autoinjectors back in the refrigerator.
3. Wait at least 30 minutes for the pre-filled autoinjector to naturally reach room temperature before injecting.
Do not try to warm the pre-filled autoinjector by using a heat source such as hot water or microwave.
Do not leave the pre-filled autoinjector in direct sunlight.
Do not shake the pre-filled autoinjector.
Do not remove the orange cap from the pre-filled autoinjector yet.
Inspect the Evolocumab (Repatha) pre-filled autoinjector.
Make sure the medicine in the window is clear and colourless to slightly yellow. Check the expiration date.
Do not use the pre-filled autoinjector if medicine is cloudy or discoloured or contains large lumps, flakes, or particles.
Do not use the pre-filled autoinjector if any part appears cracked or broken.
Do not use if the pre-filled autoinjector has been dropped.
Do not use the pre-filled autoinjector if the orange cap is missing or not securely attached.
Do not use the pre-filled autoinjector if the expiration date has passed. In all cases, use a new pre-filled autoinjector.
Gather all materials needed for your injection.
Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the new pre-filled autoinjector, alcohol wipes, cotton ball or gauze pad, plaster, sharps disposal container.
Prepare and clean your injection site.
Only use these injection sites: thigh, stomach area (abdomen), except for a 2 inch (5 centimetres) area around your belly button, outer area of upper arm (only if someone else is giving you the injection).
Clean the injection site with an alcohol wipe. Let your skin dry.
Do not touch this area again before injecting.
Choose a different site each time you give yourself an injection. If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.
Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
Step 2: Get ready.
Pull the orange cap straight off, only when you are ready to inject. Do not leave the orange cap off for more than 5 minutes. This can dry out the medicine.
It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Do not twist, bend or wiggle the orange cap.
Do not put the orange cap back onto the pre-filled autoinjector.
Do not put fingers into the yellow safety guard.
Important: Do not remove the orange cap from the pre-filled autoinjector until you are ready to inject.
If you are unable to inject, please contact your healthcare provider.
Create a firm surface at the selected injection site (thigh, stomach, or outer areas of the upper arm), by using either the stretch method or the pinch method.
Stretch method: Stretch the skin firmly by moving your thumb and fingers in the opposite direction, creating an area about 2 inches (5 centimetres) wide.
Pinch method: Pinch the skin firmly between your thumb and fingers, creating an area about 2 inches (5 centimetres) wide.
Important: It is important to keep skin stretched or pinched while injecting.
Step 3: Inject.
Keep holding the stretched or pinched skin. With the orange cap off, put the yellow safety guard on your skin at 90 degrees. The needle is inside the yellow safety guard. Do not touch the grey start button yet.
Firmly push down the pre-filled autoinjector onto the skin until it stops moving.
Important: You must push all the way down but do not touch the grey start button until you are ready to inject.
When you are ready to inject, press the grey start button. You will hear a click.
Keep pushing down on the skin. Then lift your thumb while still holding the pre-filled autoinjector on your skin. Your injection could take about 15 seconds.
Note: After you remove the pre-filled autoinjector from your skin, the needle will be automatically covered.
Step 4: Finish.
Discard the used pre-filled autoinjector and orange needle cap.
Discard the used pre-filled autoinjector and the orange cap in a sharps disposal container. Talk with your healthcare provider about proper disposal. There may be local guidelines for disposal. Keep the pre-filled autoinjector and the sharps disposal container out of the sight.
Do not reuse the pre-filled autoinjector.
Do not recap the pre-filled autoinjector or put fingers into the yellow safety guard.
Do not recycle the pre-filled autoinjector or sharps disposal container or throw them into household rubbish.
Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.