Generic Name and Formulations:
Alirocumab 75mg/mL, 150mg/mL; soln for SC inj; preservative-free.
Sanofi US and Regeneron
Indications for PRALUENT:
Adjunct to diet and maximally tolerated statin therapy, in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease requiring additional lowering of LDL-C.
Limitations Of use:
Effect on cardiovascular morbidity and mortality has not been determined.
Give by SC inj into thigh, abdomen, or upper arm; rotate inj sites. Initially 75mg once every 2 weeks. Measure LDL-C levels within 4–8 weeks of initiation or titration; may increase to max 150mg given every 2 weeks if LDL-C response is inadequate. Alternative monthly regimen: initially 300mg (two 150mg injs consecutively at two different sites) once every 4 weeks. Measure LDL-C levels just prior to next scheduled dose; may adjust dose to 150mg every 2 weeks, starting on next scheduled dosing date if LDL-C response is inadequate. HeFH undergoing LDL apheresis: 150mg once every 2 weeks; may give without regard to apheresis timing.
Do not inject into areas of active skin disease or injury (eg, sunburns, rashes, inflammation, skin infections). Discontinue if serious allergic reactions occur. Pregnancy (2nd & 3rd trimesters). Nursing mothers.
Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor.
Avoid co-administration with other injectable drugs at same inj site.
Nasopharyngitis, inj site reactions (eg, erythema/redness, itching, swelling, pain/tenderness), influenza.
To enroll pregnant women exposed to Praluent during pregnancy, call (877) 311-8972.
Single-dose prefilled pen or syringe (1mL)—1, 2