How to Use PRALUENT

The ready-to-use PRALUENT pre-filled pen was designed for self-injection at home

PRALUENT is available in 2 different dosing strengths (75 mg and 150 mg) and different dosing options.

PRALUENT comes as a single-use, pre-filled, 1-mL pen and is injected under the skin (subcutaneously).

94% of PRALUENT users were confident in their ability to self-inject*

90% found the PRALUENT pre-filled pen convenient to use*

*Evaluated in a cross-sectional, non-interventional study involving 151 patients enrolled in the PRALUENT randomized clinical trial program (ODYSSEY). The I-TAQ data is a 22-item, self-administered questionnaire, developed as a measure of injection-treatment acceptance for use in patients who inject their medications via subcutaneous injections.

PRALUENT is taken every 2 weeks or 4 weeks (monthly)

Your doctor will decide which dose of PRALUENT is right for you. Dosage may vary depending on your diagnosis. Use PRALUENT as prescribed by your doctor.

Instructions for Use — Pen 75 mg

Instructions for Use — Pen 150 mg

OR

Note: If you have been prescribed 300 mg once monthly, please utilize the

Instructions for Use — Pen 150 mg

Learn how to inject PRALUENT

You or your caregiver should receive training on the right way to prepare and administer PRALUENT. Do not try to inject PRALUENT until you have been shown the right way by your healthcare provider or nurse.

Watch the video below

Step-by-step instructions

See below for step-by-step instructions with pictures and tips.

You can also download them by clicking the button.

QUICK REFERENCE GUIDE

Getting ready for your injection

Remember to store PRALUENT in your refrigerator until you're ready to use it. Once you take it out, it takes between 30 and 40 minutes to reach room temperature and be ready for injection. PRALUENT may be left out at room temperature up to 77°F (25°C) for a maximum of 30 days in its original carton to protect it from light. After PRALUENT is removed from the refrigerator, it must be used within 30 days or thrown away.

Before you start your injection, you will need:

The PRALUENT pen

1 alcohol wipe

1 cotton ball or gauze pad

A sharps disposal container

The instructions below apply to both the 75-mg and the 150-mg pens

Step 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

Step 2

Look at the window
  • Check to make sure the liquid is clear, colorless to pale yellow, and free from particles (see picture). If it is not, do not use
  • You may see an air bubble. This is normal
  • DO NOT use if the window appears solid yellow (see picture)

Step 3

Bring to room temperature for 30-40 minutes
  • Take PRALUENT out of the refrigerator to warm up before using
    • For monthly 300-mg dosing, let two 150-mg pens come to room temperature
  • DO NOT heat the pen; let it warm up on its own
  • DO NOT expose the pen to direct sunlight
  • You may want to set a timer for 30 to 40 minutes to remind you when PRALUENT has reached room temperature and is ready to be injected
  • DO NOT put the pen back in the refrigerator

If needed, patients may keep PRALUENT at room temperature up to 77°F (25°C) for a maximum of 30 days in its original carton to protect it from light. DO NOT store above 77°F (25°C). After PRALUENT is removed from the refrigerator, it must be used within 30 days or thrown away.

Step 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 injured, tender, hard, red, or hot
  • DO NOT use any areas with visible veins, scars, or stretch marks
  • 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

How to inject

The instructions below apply to both the 75-mg pen and the 150-mg pen

Step 1

Pull off the blue needle cap

DO NOT touch the yellow safety needle cover

  • DO NOT pull off the blue needle 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 blue needle cap back on

Step 2

Hold your PRALUENT pen upright, with the yellow safety needle cover at the bottom, so that 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

Step 3

Press the yellow safety needle cover down onto your skin
  • Press the yellow safety needle cover straight down onto 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

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
  • 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

Step 4

Push and immediately release the green 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 let go of the green button
  • The window will start to turn yellow

Step 5

Hold pen in place against your skin until the entire window is yellow
  • Use the same pressure for the entire injection
  • The injection may take up to 20 seconds

Step 6

Check that the window has turned yellow before removing the pen
  • DO NOT remove the pen until the entire window has turned yellow
  • You may hear a second “click” when the injection is complete
  • If the window does not turn completely yellow, do not give yourself a second dose without speaking to your doctor, pharmacist, or nurse

Step 7

Lift 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

Step 8

Throw away pen and blue needle cap in sharps disposal container
  • DO NOT put the blue needle cap back on
  • Throw away pen and blue needle cap in a sharps disposal 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
  • Put your used pens in a sharps disposal container right after use. DO NOT throw away pens and caps in your household trash
  • 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 to prevent sharp objects from being able to come out;
    • is upright and stable during use;
    • is leak resistant; and
    • is properly labeled to warn of hazardous waste inside the container
  • DO NOT dispose of your used sharps disposal container in your household trash unless your community guidelines permit this
  • DO NOT recycle your used sharps disposal container
  • Always keep your sharps disposal container out of the sight and reach of children
  • For more information about sharps disposal in the state that you live in, go to the FDA’s website

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. If needed, patients may keep PRALUENT at room temperature up to 77°F (25°C) for a maximum of 30 days in its original carton to protect it from light. DO NOT store above 77°F (25°C). After PRALUENT is removed from the refrigerator, it must be used within 30 days or thrown away
  3. You can choose what site to inject (see below)
    1. PRALUENT is given by injection under your skin (subcutaneously) once every 2 weeks or 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 the following sites: 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 injured, tender, hard, red, hot, scarred, or any area where there are visible veins, scars, or stretch marks
    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
What if you miss a dose?
  • If you forget to use PRALUENT or are not able to take the dose at your regular time, inject your missed dose as soon as you remember, within 7 days.
  • If you missed a dose by more than 7 days and you inject every 2 weeks, wait until your next scheduled dose to restart PRALUENT or, if you inject every 4 weeks, start a new schedule from the time you remember to take your dose
  • If you are not sure when to restart PRALUENT, ask your healthcare provider or pharmacist

Need another resource? Download and print the official PRALUENT Instructions for Use here:

Instructions for 75-mg penInstructions for 150-mg pen

Hear from Gina, an actual patient, about her experience with the PRALUENT pen

Watch the video below

PRALUENT pen disposal

Once you have used your PRALUENT pen, throw it away in a sharps disposal container. Do NOT reuse the pen. Keep sharps disposal containers out of reach of children and pets.

Patients taking PRALUENT are entitled to 2 sharps disposal containers per calendar year at no cost through MyPRALUENT®. To request your sharps disposal container, call 1-844-PRALUENT (1-844-772-5836). Each container typically holds over one year's usage of PRALUENT pre-filled pens. In the event that your sharps disposal container is destroyed, lost, or broken, a third sharps disposal container can be requested.

Each state has different sharps disposal guidelines. To learn more about the rules in your state, visit www.fda.gov/safesharpsdisposal. DO NOT throw away your used sharps disposal container in your household trash unless allowed by local law.

For California residents, the law prohibits disposal of home-generated sharps waste in the trash or recycling containers. For more information about sharps disposal, visit the CalRecycle website.

Looking for additional resources?

Here’s where you can find helpful PRALUENT documents and videos.

What is PRALUENT® (alirocumab)?

PRALUENT is an injectable prescription medicine used:

  • in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization.
  • along with diet, alone or together with other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia), to reduce low-density lipoprotein cholesterol (LDL-C) or bad cholesterol.
  • along with other LDL-lowering treatments in adults with a type of high cholesterol called homozygous familial hypercholesterolemia who need additional lowering of LDL-C.

It is not known if PRALUENT is safe and effective in children.

Important Safety Information

Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT.

Before you start using PRALUENT, tell your healthcare provider about all of your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.

Tell your healthcare provider or pharmacist about any medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.

PRALUENT can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Stop using PRALUENT and call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, hives, severe itching, trouble breathing or swelling of the face, lips, throat, or tongue.

The most common side effects of PRALUENT include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Talk to your doctor about the right way to prepare and give yourself a PRALUENT injection and follow the “Instructions For Use” that comes with PRALUENT.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for Full Prescribing Information for PRALUENT.

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Still have questions about PRALUENT? Get answers

FAQs
Important Safety Information

Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT.

Before you start using PRALUENT, tell your healthcare provider about all of your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.

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