Praluent Patient Counseling Information

Instructions for use: Important information: The medicine is injected under your skin and can be given by yourself or someone else (caregiver). It is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. This pen can only be used for one single injection and must be thrown away after use. In adolescents 12 years of age and older, it is recommended that Praluent be administered by or under the supervision of an adult. In children less than 12 years of age, Praluent must be given by a caregiver.
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 you use a Praluent pen.
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 extreme heat. Do not expose the pen to direct sunlight.
75 mg/mL & 150 mg/mL: STEP A: Getting ready for an injection.
Before you start you will need the Praluent pen, alcohol wipes, cotton ball or gauze, and a puncture-resistant container (see Step B8).
1. Look at the label on the pen. Check that you have the correct product and the correct dose. Check the use by date; do not use if this date has passed.
2. Look at the window. Check the liquid is clear, colourless to pale yellow and free from particles; if not, do not use. You may see air bubble(s); 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 your hands with soap and water and dry with a towel. You can inject into your thigh, belly (except for the 5 cm area around your navel), or outer side of your upper arm. You can stand or sit to give yourself 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 each time you inject. Do not inject Praluent with other injectable medicines at the same spot.
STEP B: How to inject.
1. After completing all steps in Step A, pull off the blue cap. Do not pull off the cap until you are 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 you can see the window.
3. Press the yellow safety cover on your skin at roughly a 90° angle. Pinching of the skin before and during the injection is required in children less than 12 years of age. In adolescents 12 years of age and older and adults, pinching of skin may be required to make the injection site firm. Press and firmly hold the pen against your body until the yellow safety cover is no longer visible; the pen will not work if the yellow safety cover is not depressed fully.
4. Push and immediately release with your thumb the green button of Praluent 75 mg pen or the grey button of Praluent 150 mg pen. You will hear a click; your injection has now started. The window will start to turn yellow.
5. Keep holding the pen against your 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. Your injection is complete when the window has turned completely yellow; you may hear a second click. If the window does not turn completely yellow, call your doctor, pharmacist or nurse for help; do not give yourself a second dose without speaking to your doctor, pharmacist or nurse.
7. Pull pen away from your skin. Do not rub the skin after the injection. If you see any blood, 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 your doctor, pharmacist or nurse how to throw away the container. Always keep the container out of the sight and reach of children.
300 mg/2 mL: STEP A: Getting ready for an injection.
Before you start you will need the Praluent pen, alcohol wipes, cotton ball or gauze, and a puncture-resistant container (see Step B7).
1. Look at the label on the pen. Check that you have the correct product and the correct dose. Check the expiration date; do not use if this date has passed. Do not use the Praluent pen if it has been dropped on a hard surface or damaged.
2. Look at the window. Check the liquid is clear, colourless to pale yellow and free from particles. Do not use this medicine if the solution is discoloured or cloudy, or if it contains visible flakes or particles. You may see air bubble(s); this is normal. Do not use if the window appears solid yellow.
3. Let the pen warm up at room temperature for 45 minutes. This is important for administering the entire dose and helps minimize discomfort. 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 your hands with soap and water and dry with a towel. You can inject into the top of your thighs, your belly (except for the 5 cm area around your navel), or the outer side of your upper arm (to be given by your caregiver only). You can stand or sit to give yourself 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. Change (rotate) your injection site each time you give yourself an injection. If you need to use the same injection site, make sure it is not the same spot on the site you used last time. Do not inject Praluent with other injectable medicines at the same spot.
STEP B: How to inject.
1. After completing all steps in Step A, pull off the blue cap. Do not pull off the cap until you are ready to inject. Do not put the blue cap back on. Do not use the pen if the blue cap is missing or not securely attached.
2. Hold the Praluent pen. Do not touch the yellow safety cover; the needle is inside the yellow safety cover. Make sure you can see the window. Do not press the pen down against your skin until you are ready to inject.
3. Press the yellow safety cover on your skin at roughly a 90° angle. Pinch the skin to make sure the injection site is firm. Press the pen straight down against your skin until the yellow safety cover is pushed all the way into the pen and hold. The injection will not start until the yellow safety cover is fully depressed. There will be a click when the injection starts; the window will start to turn yellow.
4. Keep holding the pen against your skin. You may hear a second click. Check that the entire window has turned yellow. Then, slowly count to 5.
5. Check again that the window has turned yellow, before removing the pen. If the window has not turned completely yellow, remove the pen and call your doctor, pharmacist or nurse for help. Do not give yourself a second injection without speaking to your doctor, pharmacist or nurse.
6. Pull pen away from your skin. Do not rub the skin after the injection. If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.
7. 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 your doctor, pharmacist or nurse how to throw away the container. Always keep the container out of the sight and reach of children.