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

PRALUENT offers 2 powerful levels of LDL-C–lowering efficacy2

PRALUENT also offers a 300 mg monthly dosing option

  • The 300 mg monthly dose of PRALUENT is administered as 2 consecutive, subcutaneous 150 mg injections at 2 different injection sites every 4 weeks, each delivered in less than half a minute
  • Measure LDL-C levels within 4 to 8 weeks of initiating PRALUENT 75 mg Q2W or just prior to the next scheduled dose for patients receiving PRALUENT 300 mg Q4W
  • If the LDL-C response is inadequate, the dosage may be adjusted to the maximum dosage of 150 mg administered every 2 weeks. For patients adjusting from 300 mg Q4W, start the new dose on the next scheduled dosing date
  • The PRALUENT 300 mg monthly dose was not evaluated in the ODYSSEY OUTCOMES study
The recommended starting dose is 75 mg once every 2 weeks administered subcutaneously.
The majority of patients achieve sufficient LDL-C reduction with the 75 mg dosage.
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 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 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.

Easy-to-use, prefilled PRALUENT pen2-4

Same device, regardless of the dose, available in 2 different strengths2

Administered every 2 weeks or every 4 weeks (monthly) based on prescribed dose and individual patient preference.

PRALUENT 75 mg and 150 mg
are administered with a single subcutaneous 1-mL injection every 2 weeks*

PRALUENT 300 mg
monthly dose is administered as 2 consecutive, subcutaneous 150-mg injections at 2 different injection sites every 4 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 from light. The pen is not made with natural rubber latex.

*The recommended starting dose is 75 mg once every 2 weeks administered subcutaneously, or alternatively 300 mg once every 4 weeks (monthly) for patients who prefer less frequent dosing. Most patients achieve sufficient LDL-C reduction with the 75-mg dosage.2

PRALUENT offers a once-monthly dosing option with 2 injections, each delivered in up to 20 seconds

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

PRALUENT Prefilled Pen 150 mg

See access and affordability options for PRALUENT

INDICATIONS AND USAGE

PRALUENT 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 lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C).
Important Safety Information
  • PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to PRALUENT, including hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization.
  • Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis, angioedema, and 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) 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 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 PRALUENT, including hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization.
  • Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis, angioedema, and 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.
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