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 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.
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.
Avoid co-administration with other injectable drugs at same inj site.
Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor.
Nasopharyngitis, inj site reactions (eg, erythema/redness, itching, swelling, pain/tenderness), influenza.
Single-dose prefilled pen or syringe (1mL)—1, 2