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Praluent Generic Name & Formulations
Legal Class
Rx
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
