Instructions for use: Important information: The device is a single use pre-filled pen. It contains 75 mg of Praluent (alirocumab) in 1 ml.
The medicine is injected under the skin and can be given by the patient him/herself or someone else (caregiver).
This pen can only be used for one single injection, and must be thrown away after use.
Do: Keep the Praluent pen out of the sight and reach of children.
Read all of the instructions carefully before using the Praluent pen.
Follow these instructions every time a Praluent pen is used.
Store unused pens in the refrigerator at 2°C to 8°C. For detailed storage conditions, see Storage.
Do not: Do not touch the yellow safety cover.
Do not use the pen if it has been dropped or damaged.
Do not use the pen if the blue cap is missing or not securely attached.
Do not re-use a pen.
Do not shake the pen.
Do not freeze the pen.
Do not expose the pen to direct sunlight.
If there are questions, ask the doctor, pharmacist or nurse.
STEP A: Getting ready for an injection.
Before starting, the patient will need: the Praluent pen; alcohol wipes; cotton ball or gauze; a puncture resistant container (see "STEP B: How to inject", 8 as follows).
1. Look at the label on the pen.
Check if the product and dose are correct.
Check the use by date: do not use if this date has passed.
2. Look at the window.
Check if the liquid is clear, colourless to pale yellow and free from particles - if not, do not use.
An air bubble may be seen. This is normal.
Do not use if the window appears solid yellow.
3. Let the pen warm up at room temperature for 30 to 40 minutes.
Do not heat the pen, let it warm up on its own.
Do not put the pen back in the refrigerator.
4. Prepare the injection site.
Wash hands with soap and water and dry with a towel.
The patient can inject into the: Thigh; belly (except for the 5 cm area around the navel); outer side of upper arm.
The patient can stand or sit to give him/herself an injection.
Clean skin in the injection area with an alcohol wipe.
Do not use skin that is tender, hard, red or hot.
Do not use any area near a visible vein.
Use a different spot to inject each time.
Do not inject Praluent with other injectable medicines at the same spot.
STEP B: How to inject.
1. After completing all previous steps in "STEP A: Getting ready for an injection", pull off the blue cap.
Do not pull off the cap until ready to inject.
Do not put the blue cap back on.
2. Hold the Praluent pen.
Do not touch the yellow safety cover.
Make sure the window can be seen.
3. Press the yellow safety cover on the skin at roughly a 90° angle.
Press and firmly hold the pen against the body until the yellow safety cover is no longer visible. The pen will not work if the yellow safety cover is not depressed fully.
If needed, pinch the skin to make sure the injection site is firm.
4. Push and immediately release the green button with the thumb.
A click will be heard. The injection has now started.
The window will start to turn yellow.
5. Keep holding the pen against the skin after releasing the button.
The injection may take up to 20 seconds.
6. Check if the window has turned yellow, before removing the pen.
Do not remove the pen until the entire window has turned yellow.
The injection is complete when the window has turned completely yellow. A second click may be heard.
If the window does not turn completely yellow, call sanofi-aventis for help. Do not give a second dose without speaking to the doctor, pharmacist or nurse.
7. Pull pen away from the skin.
Do not rub the skin after the injection.
If any blood is seen, press a cotton ball or gauze on the site until the bleeding stops.
8. Throw away pen and cap.
Do not put the blue cap back on.
Throw away pen and cap into a puncture resistant container immediately after use.
Ask the doctor, pharmacist or nurse how to throw away the container.
Always keep the container out of the sight and reach of children.