Praluent

— THERAPEUTIC DISORDERS TREATED —
  • Hyperlipoproteinemias

Praluent Generic Name & Formulations

General Description

Alirocumab 75mg/mL, 150mg/mL; soln for SC inj; preservative-free.

Pharmacological Class

Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor.

How Supplied

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

Manufacturer

Generic Availability

NO

Praluent Indications

Indications

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.

Praluent Dosage and Administration

Adult

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

Not established.

Praluent Contraindications

Not Applicable

Praluent Boxed Warnings

Not Applicable

Praluent Warnings/Precautions

Warnings/Precautions

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

Praluent Pharmacokinetics

See Literature

Praluent Interactions

Interactions

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

Praluent Adverse Reactions

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.

Praluent Clinical Trials

See Literature

Praluent Note

Notes

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

Praluent Patient Counseling

See Literature