Living with familial hypercholesterolemia (FH)?

In addition to adults with heterozygous FH (HeFH), PRALUENT is now approved to lower bad (LDL) cholesterol in adults with homozygous FH (HoFH) along with other cholesterol-lowering treatments.

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PRA.21.04.0005

Results & Safety

Results with PRALUENT

PRALUENT is proven to reduce the risk of heart attack, stroke, and certain types of chest pain conditions (unstable angina) requiring hospitalization in adults with cardiovascular disease.

PRALUENT was studied in a large clinical trial of ~19,000 patients who had a previous heart attack or unstable angina requiring hospitalization. In this study, patients were taking the highest-tolerated dose of statin, with or without other cholesterol-lowering medications, and received either PRALUENT (9,462 patients) or placebo (9,462 patients).

Patients who received PRALUENT showed:

*Patients treated with PRALUENT had fewer heart attacks (6.6%) compared to placebo (7.6%).

Patients treated with PRALUENT had fewer strokes (1.2%) compared to placebo (1.6%).

Patients treated with PRALUENT had fewer cases of unstable angina requiring hospitalization (0.4%) compared to placebo (0.6%).

In the same clinical study, fewer deaths were observed among patients treated with PRALUENT (3.5%) than those not treated with PRALUENT (4.1%).

PRALUENT has also been shown to effectively reduce bad (LDL) cholesterol.

In clinical studies (12-24 weeks) of adults with high blood cholesterol levels (including those with a type of high cholesterol called heterozygous familial hypercholesterolemia, also known as HeFH), adding PRALUENT reduced bad cholesterol levels from baseline by an average of

when taken alone or with other cholesterol-lowering medications and a healthy diet.

In a clinical trial of adults with homozygous familial hypercholesterolemia (HoFH), PRALUENT lowered bad cholesterol by an average of 36% compared to placebo when used with other cholesterol-lowering medications at 12 weeks.

Not an actual patient.

Before starting PRALUENT

It’s important you tell your doctor 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 doctor if you become pregnant while taking PRALUENT.

Breastfeeding or plan to breastfeed. You and your doctor should decide if you would take PRALUENT or breastfeed. You should not do both without talking to your doctor 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 any medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.

Talk to your doctor

Be prepared for your next doctor visit. Use these talking points to start the conversation about PRALUENT.

Possible side effects

PRALUENT can also cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Stop using 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, or tongue.

The most common side effects include:

Redness, itching, swelling, or pain/tenderness at the injection site
Symptoms of the common cold
Flu or flu-like symptoms

Tell your doctor 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 doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

Not an actual patient.

Download information about PRALUENT

Learn how PRALUENT can help reduce the risk of having a heart attack, stroke, or unstable angina.

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 http://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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