INDICATIONS AND USAGE

PRALUENT® is indicated:

·To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

·As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.

·As an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

DOSAGE

Recommended Dosage

·In adults with established cardiovascular disease or with primary hyperlipidemia, including HeFH:

The recommended starting dose of PRALUENT is either 75 mg once every 2 weeks or 300 mg once every 4 weeks administered subcutaneously.

For patients receiving PRALUENT 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dose, because LDL-C can vary between doses in some patients.

If the LDL-C response is inadequate, the dosage may be adjusted 150 mg subcutaneously every 2 weeks.

·In adults with HeFH undergoing LDL apheresis or in adults with HoFH:

The recommended dose of PRALUENT is 150 mg once every 2 weeks administered subcutaneously.

PRALUENT can be administered without regard to the timing of LDL apheresis.

·Assess LDL-C when clinically appropriate. The LDL-lowering effect of PRALUENT may be measured as early as 4 weeks after initiation.

ADVERSE REACTIONS

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

symptoms of the common cold

flu or flu-like symptoms

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/a20eb852-4c25-49f0-98bc-aed493336e75/spl-doc?hl=Praluent

Praluentinformation