Patient information: uses, side effects, how to take - Praluent

What is PRALUENT?

PRALUENT is an injectable prescription medicine used:

to reduce the risk of major adverse cardiovascular (CV) events, such as death from coronary heart disease, heart attack, stroke, or certain types of chest pain conditions (unstable angina) requiring hospitalization, in adults at increased risk for these events.
along with diet and exercise, to reduce low-density lipoprotein cholesterol (LDL-C) or bad cholesterol in:
- adults with high blood cholesterol levels called hypercholesterolemia.
- adults and children aged 8 years and older with a type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).
- adults with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).

It is not known if PRALUENT is safe and effective in children who are younger than 8 years of age or in children with other types of high cholesterol (hypercholesterolemia).

Who should not use PRALUENT?

Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT. See the end of this leaflet for a complete list of ingredients in PRALUENT.

What should I tell my healthcare provider before using 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. It is not known if PRALUENT will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking PRALUENT.
are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take PRALUENT or breastfeed. You should not do both without talking to your healthcare provider first.

If you are pregnant during PRALUENT treatment, you are encouraged to call Regeneron at 1-844-734-6643 to share information about the health of you and your baby.

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

How should I use PRALUENT?

See the detailed "Instructions for Use" that comes with this Patient Information about the right way to prepare and give your PRALUENT injections.
Use PRALUENT exactly as your healthcare provider tells you to use it.
PRALUENT comes as a single-dose (1 time) pre-filled pen (autoinjector). Your healthcare provider will prescribe the dosage that is best for you.
If your healthcare provider decides that you or a caregiver can give the injections of PRALUENT, you or your caregiver should receive training on the right way to prepare and give PRALUENT. Do not try to inject PRALUENT until you have been shown the right way by your healthcare provider or nurse.
In children aged 12 to 17 years, it is recommended that PRALUENT be given by or under the supervision of an adult. In children aged 8 to 11 years, PRALUENT should be given by a caregiver.
PRALUENT is injected under the skin (subcutaneously) every 2 weeks or every 4 weeks (monthly).
If your healthcare provider prescribes you the monthly dose, give 2 separate injections in a row, using a different pen for each injection and 2 different injection sites.
Do not inject PRALUENT together with other injectable medicines at the same injection site.
Always check the label of your pen to make sure you have the correct medicine and the correct dose of PRALUENT before each injection.
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. Then, if you inject every 2 weeks take your next dose in 2 weeks from the day you missed your dose or if you inject every 4 weeks take your next dose in 4 weeks from the day you missed your dose. This will put you back on your original schedule.
If you missed a dose by more than 7 days and you inject every 2 weeks wait until your next scheduled dose to re-start 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 re-start PRALUENT, ask your healthcare provider or pharmacist.
If you use more PRALUENT than you should, talk to your healthcare provider or pharmacist.
Do not stop using PRALUENT without talking with your healthcare provider. If you stop using PRALUENT, your cholesterol levels can increase.

What are the possible side effects of PRALUENT?

PRALUENT can cause serious side effects, including:

allergic reactions. PRALUENT may cause 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

swelling of the face, lips, throat or tongue

The most common side effects of PRALUENT include:

redness, itching, swelling, pain, or tenderness at the injection site

flu
muscle pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of PRALUENT. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of PRALUENT.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PRALUENT for a condition for which it was not prescribed. Do not give PRALUENT to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about PRALUENT. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about PRALUENT that is written for health professionals.

For more information about PRALUENT, go to www.PRALUENT.com or call 1-844-PRALUENT (1-844-772-5836).

What are the ingredients in PRALUENT?

Active ingredient: alirocumab

Inactive ingredients: histidine, polysorbate 20, sucrose, and Water for Injection, USP.

Manufactured by: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807; A SANOFI COMPANY, U.S. License # 1752; Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591) / PRALUENT is a registered trademark of Sanofi / ©2025 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC

Instructions For Use

PRALUENT ^®(PRAHL-u-ent)

(alirocumab)

Injection, for Subcutaneous Injection

Single-Dose Pre-Filled Pen (75 mg/mL)

Important Information

The device is a single-dose disposable pen. It contains 75 mg of PRALUENT (alirocumab) in 1 mL.
The PRALUENT pen contains medicine prescribed by your healthcare provider.
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.
In children aged 8 to 11 years, PRALUENT must be given by a caregiver.
In children aged 12 to 17 years, it is recommended that PRALUENT be given by or under supervision of an adult.

This pen can only be used for 1 single injection, and must be thrown away (discarded) after use.
Read all of the instructions carefully before using the PRALUENT pen.
Follow these instructions every time you use a PRALUENT pen.
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.

Storage of PRALUENT

Store unused pens in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
Do not freeze.
Do not expose the pen to extreme heat or direct sunlight.
Do not shake.
PRALUENT should be allowed to warm to room temperature for 30 to 40 minutes before use.
If needed, PRALUENT may be kept at room temperature up to 77°F (25°C) for 30 days in the original carton to protect 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.
Keep the PRALUENT pens and all medicines out of the reach of children.

Keep this leaflet. If you have questions, ask your healthcare provider or call 1-844-PRALUENT (1-844-772-5836).

The parts of the PRALUENT pen are shown in this picture.

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 sharps container or 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 (EXP): do not use if this date has passed.

A2: Look at the window.

Check the liquid is clear, colorless to pale yellow and free from particles (see Figure A).
You may see air bubbles. 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.

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.
Do not put the pen back in the refrigerator.

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 (see picture):
- thighs
- stomach (except for the 2 inch area around your belly button)
- 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 tender, bruised, hard, or red. Do not inject PRALUENT into areas with visible veins, scars or stretch marks.

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.

B2: Hold the PRALUENT pen like this.

Do not touch the yellow safety cover.
Make sure you can see the window.

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

For children younger than 12 years of age, pinching the skin before and during the injection is required.
In adults and children aged 12 years and older, 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.

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.

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

The injection may take up to 20 seconds.

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.

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.

B8: Throw away (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.

Disposing of used pens:

Put your used pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) pens and caps in your household trash.
If you do not have a 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 the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
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.

Keep PRALUENT and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

A SANOFI COMPANY

U.S. License # 1752

Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807)

and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)

PRALUENT is a registered trademark of Sanofi

Revised: March 2024