PRALUENT offers powerful dosing options

The easy-to-use prefilled PRALUENT pen 2-4, (see recommended dosing below)

Administered as single, subcutaneous injections every 2 weeks.

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

Monthly dose of PRALUENT is administered as 2 consecutive, subcutaneous 150-mg injections at 2 different injection sites every 4 weeks, each delivered in up to 20 seconds.

  • Measure LDL-C just prior to the next scheduled dose for patients receiving PRALUENT 300 mg Q4W
  • If the LDL-C response is inadequate, the dosing may be adjusted to the maximum dosage of 150 mg administered every 2 weeks

If needed, patients may keep PRALUENT at room temperature up to 77°F (25°C) for a maximum of 30 days in the original carton to protect it from the light. The pen is not made with natural rubber latex.

PRALUENT recommended dosing

Recommended dosing for the prevention of cardiovascular events and primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)1

  • The recommended starting dose of PRALUENT is 75 mg once every 2 weeks administered subcutaneously, or 300 mg once every 4 weeks (monthly)
  • 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

Recommended dosing for homozygous familial hypercholesterolemia (HoFH)1

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

The 75-mg PRALUENT dose was used 78% of the time in ODYSSEY OUTCOMES1

Recommended dosing for homozygous familial hypercholesterolemia (HoFH)1

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

Patients self-injected at home with confidence and convenience4†

†Evaluated in a cross-sectional, noninterventional study involving 151 patients enrolled in the PRALUENT randomized clinical trial program (ODYSSEY). The I-TAQ is a 22-item, self-administered questionnaire, developed as a measure of injection-treatment acceptance for use in patients who inject their medications via subcutaneous injections.4

How to Use the PRALUENT Prefilled Pen

Share the PRALUENT Prefilled Pen Instructions for Use with your patients

PRALUENT Prefilled Pen 75 mg

Instructions for use

PRALUENT Prefilled Pen 150 mg

Instructions for use

See access and affordability options for PRALUENT

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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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