PRALUENT Dosage & Rx Info | Uses, Side Effects

Praluent Generic Name & Formulations

Legal Class

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

Regeneron

Generic Availability

Mechanism of Action

Alirocumab is a human monoclonal antibody that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptors (LDLR) on the surface of hepatocytes to promote LDLR degradation within the liver. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.

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. Adjunct to diet and other LDL-C-lowering therapies in pediatric patients with HeFH 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

Established cardiovascular disease, primary hyperlipidemia, and HoFH: <18yrs: not established. HeFH: <8yrs: not established. Give by SC inj into thigh, abdomen, or upper arm; rotate inj sites. HeFH: ≥8yrs (<50kg): 150mg once every 4 weeks; may adjust to 75mg once every 2 weeks if LDL-C response is inadequate. (≥50kg): 300mg once every 4 weeks; may adjust to 150mg once every 2 weeks if LDL-C response is inadequate. Assess LDL-C when clinically appropriate; may be measured as early as 4 weeks after initiation.

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

Absorption

Absolute bioavailability: ~85%. Median time to maximum serum concentration: 3 to 7 days.

Distribution

Volume of distribution: ~0.04 to 0.05 L/kg.

Elimination

Half-life (median): 17–20 days.

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