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Administration of PRALUENT® (alirocumab)

Administration of PRALUENT

When starting a new treatment, it’s only natural that you may have questions. Your doctor will show you how to inject PRALUENT. See the detailed Instructions for Use below for information about the right way to prepare and give the PRALUENT injections at home with the easy to use pre-filled pen. Or, click one of these links to download and print:

Instructions For Use — Pen

Instructions For Use — Syringe


A MyPRALUENT™ nurse is on call 7 days a week, 24 hours a day to provide self-injection support and training. Just call us at 1-844-PRALUENT (1-844-772-5836) and press 1.

PRALUENT® (alirocumab) Administration
Patients self-injected at home with confidence and convenience*
  • 94% were confident in their ability to self-inject
  • 90% found the injection convenient to use

Instructions for Use

Step A: Getting ready for your injection

Before you start you will need:
  • The PRALUENT pen
  • 1 alcohol wipe
  • 1 cotton ball or gauze
  • A puncture-resistant container (see Step B8)

A1: 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.
Look at the label on the PRALUENT® (alirocumab) pen

A2: Look at the window.

  • Check the liquid is clear, colorless to pale yellow and free from particles (see Figure A).
  • You may see an air bubble. This is normal.
  • Do not use if the window appears solid yellow (see Figure B).
  • Do not use this medicine if the solution is discolored or cloudy, or if it contains visible flakes or particles.
Look at the window on the PRALUENT® (alirocumab) pen

A3: Let the pen warm up at room temperature for 30 to 40 minutes.

  • This is important for administering the entire dose and helps minimize discomfort.
  • Take PRALUENT out of the refrigerator to warm up before using.
  • Do not heat the pen, let it warm up on its own.
  • Use the pen as soon as possible after it has warmed up.
  • Do not put the pen back in the refrigerator.
Let the PRALUENT® (alirocumab) pen warm up at room temperature for 30 to 40 minutes

A4: Prepare the injection site.

  • Wash your hands with soap and water and dry with a towel.
  • Clean skin in the injection area with an alcohol wipe.
  • You can inject into your :
    • o Thighs
    • o Stomach (except for the 2 inch area around your navel)
    • o Upper arms
  • You can stand or sit to give yourself an injection.
Important:
  • 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 into areas where the skin is injured, tender, hard, red, or hot. Do not inject PRALUENT into areas with visible veins, scars or stretch marks.
Prepare the injection site

Step B: How to give your injection

B1: After completing all steps in “Step A: Getting ready for your injection,” 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.
Pull off the blue cap on the PRALUENT® (alirocumab) pen

B2: Hold the PRALUENT pen like this.

  • Do not touch the yellow safety cover.
  • Make sure you can see the window.
How to hold the PRALUENT® (alirocumab) pen

B3: Press the yellow safety cover on your skin at roughly a 90° angle.

  • 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.
  • If needed, pinch the skin to make sure the injection site is firm.
Press the yellow safety cover on your skin at a 90 degree angle

B4: Push and immediately release the green button with your thumb.

  • You will hear a click. Your injection has now started.
  • The window will start to turn yellow.
Push and release the green button with your thumb

B5: Keep holding the pen against your skin after releasing the button.

  • The injection may take up to 20 seconds.
  • The time required for injection to give the entire dose may be longer than for other injectable medicines.
Continue holding the PRALUENT® (alirocumab) pen against your skin after releasing the button

B6: Check 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 1-844-772-5836 for help. Do not give yourself a second dose without speaking to your healthcare provider.
Make sure the window has turned yellow before removing the PRALUENT® (alirocumab) pen

B7: 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.
Pull the PRALUENT® (alirocumab) pen away from your skin

B8: Discard pen and cap.

  • Do not put the blue cap back on.
  • Throw away pen and cap in a puncture-resistant container immediately after they have been used.
How to discard the PRALUENT® (alirocumab) pen

Important things to know and to keep in mind when self-injecting with PRALUENT:

  1. Have the Instructions for Use at hand as a reference for information on the right way to prepare and give the PRALUENT injections at home with the easy to use pre-filled pen
  2. It’s easy to make PRALUENT part of your routine
    1. Store PRALUENT in your refrigerator until you’re ready to use it
    2. PRALUENT should be allowed to warm to room temperature for 30 to 40 minutes before use. An easy way to do this is to take it out of the refrigerator while you’re eating breakfast or dinner. It will be warm enough to inject after you’re done eating
    3. Do not keep PRALUENT at room temperature for more than 24 hours
  3. You can choose where to inject
    1. PRALUENT is given by injection under your skin (subcutaneously) once every 2 weeks
    2. You can inject PRALUENT into your thigh, the back of your upper arm (generally given by a care provider), or your stomach
    3. Do not use PRALUENT within 2 inches of your belly button; or where the skin is sore, tender, bruised, red, hard, scarred, or where there are visible veins
    4. Choose a different spot each time you inject (for example, right thigh, then left thigh, or right side of stomach then left side of stomach)
    5. If you take other self-injection medications, choose a different area to inject PRALUENT

*Evaluated in a cross-sectional, non-interventional study involving 151 patients enrolled in the PRALUENT randomized clinical trial program (ODYSSEY). Using the I-TAQ data, a number of analyses were performed to confirm the appropriateness of the hypothesized scoring and evaluate the psychometric properties of the I-TAQ domain scores and total score. These analyses included evaluation of item response distributions, factor analysis, multi-trait analysis, inter-item correlations, convergent validity through examining correlations with an existing measure of acceptance and known groups/discriminative validity.

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