Hyperlipoproteinemias:

Indications for: PRALUENT

To reduce the risk of MI, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. Adjunct to diet, alone or in combination with other lipid-lowering therapies (eg, statins, ezetimibe) in adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce LDL-C. Adjunct to other LDL-C-lowering therapies in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Adult Dosage:

Give by SC inj into thigh, abdomen, or upper arm; rotate inj sites. Established cardiovascular disease, primary hyperlipidemia, and HeFH: initially 75mg once every 2 weeks or 300mg (two 150mg injs consecutively at two different sites) once every 4 weeks. May adjust dose to 150mg once every 2 weeks if LDL-C response is inadequate. For monthly regimen: measure LDL-C just prior to next scheduled dose. HeFH undergoing LDL apheresis or HoFH: 150mg once every 2 weeks; may give without regard to apheresis timing. All: assess LDL-C when clinically appropriate; may be measured as early as 4 weeks after initiation.

Children Dosage:

Not established.

PRALUENT Warnings/Precautions:

Discontinue if serious hypersensitivity reactions occur; treat appropriately and monitor until resolved. Severe renal or hepatic impairment. Pregnancy. Nursing mothers.

PRALUENT Classification:

Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor.

PRALUENT Interactions:

Avoid co-administration with other injectable drugs at same inj site.

Adverse Reactions:

Nasopharyngitis, inj site reactions (eg, erythema/redness, itching, swelling, pain/tenderness), influenza; for established cardiovascular disease: also non-cardiac chest pain, myalgia; hypersensitivity reactions.

Note:

To enroll pregnant women exposed to Praluent during pregnancy, call (877) 311-8972.

Generic Drug Availability:

NO

How Supplied:

Single-dose prefilled pen or syringe (1mL)—1, 2