Patient Information
Prescribing Information

IMPORTANT PRESCRIBING AND SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Do not use PRALUENT if you are allergic to alirocumab or to any of the ingredients in PRALUENT.
Before starting PRALUENT, tell your healthcare provider about all 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 prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

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

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 healthcare provider about the right way to prepare and give yourself a PRALUENT injection and follow the "Instructions for Use" that comes with PRALUENT.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.

WHAT IS PRALUENT (alirocumab)?

PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol.

The effect of PRALUENT on heart problems such as heart attacks, stroke, or death is not known.

Safety and efficacy in children is unknown.

Click here for Full Prescribing Information for PRALUENT.

*Heterozygous familial hypercholesterolemia, an inherited condition that causes high levels of LDL.

© 2016 Sanofi US and Regeneron Pharmaceuticals, Inc. All rights reserved.

US.ALI.16.06.144 US-PRB-12188 06/2016