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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 75 mg

Instructions For Use — Pen 150 mg

Note: if you have been prescribed 300 mg once monthly,
please utilize the Instructions For Use – Pen 150 mg.


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

PRALUENT® (alirocumab) Pen Key Features

Before you start you will need:

The ready-to-use PRALUENT Pen was
designed for self-injection at home

The yellow safety needle cover keeps
the needle hidden throughout the
entire injection

A "click" sound tells you that the injection
has started

The window turns yellow when the
injection is completed so you know
the full dose has been delivered

Getting ready for your injection

Before you start your injection, you will need:

1 alcohol
wipe

1 cotton ball
or gauze pad

A sharps disposal
container

For self-injecting the monthly 300 mg dose,
prepare two 150 mg pens.

1: Look at the label

  • 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 pen if it has been dropped or damaged.
Look at the label on the PRALUENT® (alirocumab) pen

2: Look at the window.

  • Check the liquid is clear, colorless to pale yellow and free from particles (see picture). If not, do not use.
  • You may see air bubbles. This is normal.
  • DO NOT use if the window appears solid yellow (see picture).
Look at the window on the PRALUENT® (alirocumab) pen

3: BRING to room temperature for 30-40 minutes

  • Remove PRALUENT® (alirocumab) from the refrigerator only when you are ready to inject
  • Let two 150 mg pens come to room temperature for the monthly 300 mg dose
  • DO NOT heat the pen; let it warm up on its own
  • DO NOT expose the pen to direct sunlight
  • Use the pen as soon as possible after it has warmed up
  • You may want to set a timer for 30-40 minutes to remind you when PRALUENT has reached room temperature and is ready to be injected
Let the PRALUENT® (alirocumab) pen warm up at room temperature for 30 to 40 minutes

4: Prepare the injection site

Injection Sites:
  • Top of thigh
  • Belly (except for the 2-inch area around your navel)
  • Outer side of your upper arms (for caregivers)
  • Wash your hands with soap and water and dry with a towel
  • Clean skin in the injection area with an alcohol wipe
  • DO NOT use on skin that is tender, hard, red, or hot
  • DO NOT use any area near a visible vein
  • Change 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 you used last time
  • Reminder: Use a different injection site for the second injection of the monthly 300 mg dose
Prepare the injection site

How to inject

The instructions below use the 75 mg pen as an example

1: PULL off the blue needle cap

DO NOT touch the yellow safety needle cover

  • DO NOT pull off the cap until you are ready to inject
  • DO NOT use the pen if the blue needle cap is missing or not securely attached
  • DO NOT put the cap back on
Pull off the blue cap on the PRALUENT® (alirocumab) pen

2: HOLD the PRALUENT pen like this so you can see the window.

Your thumb should not touch the green button yet

  • DO NOT shake the pen
  • DO NOT touch the yellow safety needle cover
  • Make sure the inspection window is facing you and that you can see it
How to hold the PRALUENT® (alirocumab) pen

3: PRESS down the yellow safety needle cover on your skin

  • Press the yellow safety needle cover straight down on your skin at roughly a 90° angle
  • DO NOT lift the pen from your skin
  • Use the same pressure for the entire injection
  • If needed, pinch the skin to make sure the injection site is firm
    • – It is important to keep the skin pinched while injecting
  • DO NOT touch the green button yet
  • Firmly press down until the yellow safety needle cover disappears into the pen and is no longer visible

The pen will not work if the yellow safety needle cover is not pushed all the way down

OR

4: PUSH and immediately release the button

  • Continue to firmly press down so that the yellow safety needle cover is not visible
  • You will hear a "click." Your injection has now started
  • Immediately release the button
  • The window will start to turn yellow
Push and release the green button with your thumb

5: HOLD in place until entire window is yellow

  • Use the same pressure for the entire injection
  • The injection may take up to 20 seconds
Continue holding the PRALUENT® (alirocumab) pen against your skin after releasing the button

6: CHECK the window has turned yellow

  • DO NOT remove the pen until the entire window has turned yellow
  • Your may hear a second "click" when the injection is complete
  • If the window does not turn completely yellow, call 1-844-PRALUENT (1-844-772-5836) and press 1. Do not give yourself a second dose without speaking to your doctor, pharmacist, or nurse

7: Lift pen away from your skin

  • DO NOT rub the skin after the injection
  • You may see a drop of blood at the injection site
Pull the PRALUENT® (alirocumab) pen away from your skin

8: THROW away pen and needle cap

  • DO NOT put the blue needle cap back on
  • Throw away pen and needle cap into a puncture-resistant container right after use
  • For the monthly 300 mg dose, throw out the first 150 mg pen before repeating the steps for your second injection
  • Always keep the container out of the sight and reach of children
  • DO NOT reuse the pen

When self-injecting the monthly 300 mg dose, repeat ALL steps with a second 150 mg pen at a different injection site

  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • – made of a heavy-duty plastic;
    • – can be closed with a tight-fitting; puncture-resistant lid, without sharps being able to come out;
    • – upright and stable during use;
    • – leak resistant; and
    • – properly labeled to warn of hazardous waste inside

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. You can 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 or every 4 weeks (monthly dosing option). If your healthcare provider prescribes you the monthly dose, you will give yourself 2 separate injections in a row, using a different pen for each injection and 2 different injection sites.
    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

*Eligible patients with commercial insurance not funded through a government healthcare program subject to an annual cap and other program terms and restrictions. This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicaid, Medicare, VA, DOD, TRICARE, or similar federal or state programs.

†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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