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PRA.21.10.0002

LDL-C reduction: PRALUENT vs ezetimibe

LDL-C reduction at 24 weeks on top of maximally tolerated statins (vs ezetimibe) in the COMBO II Study with PRALUENT 75 mg Q2W/150 mg Q2W1,2

COMBO II (Study 9) was a multicenter, double-blind, ezetimibe-controlled trial that compared PRALUENT (n=479) with ezetimibe (n=241). Patients were taking maximally tolerated doses of statins and required additional LDL-C reduction. Patients received either PRALUENT 75 mg Q2W or ezetimibe 10 mg once daily in addition to their existing statin therapy. Up-titration of PRALUENT to 150 mg Q2W occurred at Week 12 in patients with LDL-C ≥70 mg/dL at Week 8. 18% of PRALUENT patients needed to be up-titrated at Week 12 from 75 mg to 150 mg Q2W.1,3

82% of patients achieved LDL-C goal (<70 mg/dL) at Week 8 and did not require dose adjustment at Week 12 in the COMBO II Study1,3

  • In COMBO II, adverse reactions occurring in ≥5% of PRALUENT-treated patients and more frequently than with ezetimibe were accidental overdose, upper respiratory tract infection, hypertension, headache, and arthralgia2

Significant reductions in LDL-C were also seen in FH trials

For adults with established CV disease or primary hyperlipidemia, including HeFH,

PRALUENT offers a once-monthly starting dose option

LDL-C–lowering power with the

from baseline at 24 weeks with PRALUENT 300 mg Q4W/150 mg Q2W vs -1% for placebo (P<0.0001) in the cohort of patients on background statin in the CHOICE I Study1,4

CHOICE I (Study 7) was a multicenter, double-blind, placebo-controlled trial that compared PRALUENT 300 mg Q4W(n=458), PRALUENT 75 mg Q2W (n=115), and placebo (n=230). Patients were stratified based on whether or not they were treated concomitantly with statin. The mean age was 61 years (range 21-88), 42% were women, 87% were Caucasian, 11% were Black, and 3% were Hispanic/Latino. In the cohort of patients on background statin, the mean baseline LDL-C was 113 mg/dL. A primary efficacy endpoint measure at Week 24 was the mean percent change in LDL-C from baseline. The dose was up-titrated to 150 mg Q2W at Week 12, based on prespecified LDL-C criteria at Week 8, in approximately 20% of patients treated with PRALUENT 75 mg Q2W or 300 mg Q4W.1

The recommended starting dose of PRALUENT is 75 mg once every 2 weeks administered subcutaneously or 300 mg once every 4 weeks (monthly) for the prevention of CV events and primary hyperlipidemia, including HeFH. If the LDL-C response is inadequate, the dosage may be adjusted to 150 mg administered every 2 weeks.

In adults with HeFH undergoing LDL apheresis, the recommended dose of PRALUENT is 150 mg once every 2 weeks administered subcutaneously. PRALUENT can be administered without regard to the timing of LDL apheresis.

The recommended dose of PRALUENT for patients with HoFH is 150 mg once every 2 weeks administered subcutaneously.

Assess LDL-C when clinically appropriate. The LDL-lowering effect of PRALUENT may be measured as early as 4 weeks after initiation.

  • PRALUENT once-monthly (Q4W) 300-mg dose: administered as 2 consecutive, subcutaneous 150-mg injections at 2 different injection sites every 4 weeks1
  • For patients receiving PRALUENT 300-mg every 4 weeks, measure LDL-C just prior to the next scheduled dose, because LDL-C can vary between doses in some patients.2 If LDL-C reduction is inadequate, the dose may be adjusted to 150 mg every 2 weeks1
  • The once-monthly 300-mg dosing regimen had a higher rate of local injection site reactions as compared to PRALUENT 75 mg Q2W or placebo (16.6%, 9.6%, and 7.9%, respectively) in a trial in which all patients received an injection of drug or placebo every 2 weeks to maintain the blind. The discontinuation rate due to injection site reactions was 0.7% in the 300-mg Q4W arm and 0% in the other 2 arms1

PRALUENT provided powerful LDL-C reductions in primary hyperlipidemia studies

from baseline at 24 weeks with PRALUENT 75 mg Q2W/150 mg vs -2% for placebo (P<0.0001) in the COMBO I Study1

COMBO I (Study 3) was a multicenter, double-blind, placebo-controlled trial that compared PRALUENT (n=209) with placebo (n=107). Patients were taking maximally tolerated doses of statins with or without other lipid-modifying therapy, and required additional LDL‑C reduction. The mean age was 63 years (range 39-87), 34% were women, 82% were Caucasian, 16% were Black, and 11% were Hispanic/Latino. Mean baseline LDL-C was 102 mg/dL.1

with PRALUENT 150 mg Q2W vs +1% for placebo at Week 24 (P<0.0001) in the LONG TERM Study1

LONG TERM trial (Study 2) was a multicenter, double-blind, placebo-controlled trial that compared PRALUENT 150 mg Q2W (n=1553) with placebo (n=788). The average LDL-C at baseline was 122 mg/dL.1

LDL-C reductions with PRALUENT as monotherapy1

In patients wtih moderate CV risk, PRALUENT as monotherapy had significant and consistent LDL-C reduction1

  • The mean percent change in LDL-C at Week 24 from baseline was -45% with PRALUENT vs -14% with ezetimibe
  • The treatment difference between PRALUENT and ezetimibe in mean LDL-C percent change was -31% (95% CI: -40%, -22%; P<0.0001)

MONO (Study 10) was a multicenter, double-blind, ezetimibe-controllerd trial comparing PRALUENT 75 mg Q2W (n=52) to ezetimibe 10 mg/day (n=51) in patients with moderate CV risk, not taking statins or other lipid-modifying therapies. Baseline LDL-C was between 100 mg/dL and 190 mg/dL.1

LDL-C = low-density lipoprotein cholesterol; Q2W = every 2 weeks; Q4W = once monthly.

Find appropriate patients for PRALUENT

INDICATIONS AND USAGE

PRALUENT® (alirocumab) is indicated:

  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
  • as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies in adults with primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C.
  • as an adjunct to other LDL-C-lowering therapies in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
Important Safety Information
  • PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. Hypersensitivity reactions, including hypersensitivity vasculitis, angioedema, and other hypersensitivity reactions requiring hospitalization, have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve.
  • The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia (including heterozygous familial hypercholesterolemia (HeFH)) (≥5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza.
  • The most commonly occurring adverse reactions in the cardiovascular outcomes trial (>5% of patients treated with PRALUENT and occurring more frequently than placebo) were non-cardiac chest pain, nasopharyngitis, and myalgia.
  • In the primary hyperlipidemia (including HeFH) clinical trials, local injection site reactions including erythema/redness, itching, swelling, and pain/tenderness were reported more frequently in patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks (7.2% versus 5.1% for PRALUENT and placebo, respectively). Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo.
  • The once-monthly (Q4W) 300mg dosing regimen had a higher rate of local injection site reactions as compared to PRALUENT 75mg Q2W or placebo (16.6%, 9.6%, and 7.9%, respectively). The discontinuation rate due to injection site reactions was 0.7% in the 300 mg Q4W arm and 0% in the other 2 arms.
  • In a cardiovascular outcomes trial, local injection site reactions were reported in 3.8% of patients treated with PRALUENT versus 2.1% patients treated with placebo, and led to permanent discontinuation in 0.3% of patients versus <0.1% of patients, respectively.
  • In the primary hyperlipidemia trials, liver-related disorders (primarily related to abnormalities in liver enzymes) were reported in 2.5% of patients treated with PRALUENT and 1.8% of patients treated with placebo, leading to treatment discontinuation in 0.4% and 0.2% of patients, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with PRALUENT and 1.4% of patients treated with placebo.
  • In the primary hyperlipidemia trials, the most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%).
  • PRALUENT is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with PRALUENT.
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Important Safety Information
  • PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. Hypersensitivity reactions, including hypersensitivity vasculitis, angioedema, and other hypersensitivity reactions requiring hospitalization, have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve.
  • The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia (including heterozygous familial hypercholesterolemia (HeFH)) (≥5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza.
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