For U.S. Healthcare Professionals Only

Instructions for Use:

75 mg Pen 150 mg Pen

PRALUENT Administration
Easy-to-use, prefilled PRALUENT pen1-3
Same device, regardless of the dose, available in 2 different strengths1
Administered every 2 weeks or every 4 weeks (monthly) based on prescribed dose and individual patient preference
PRALUENT 75 mg & 150 mg

are administered with a single subcutaneous 1-mL injection every 2 weeks*

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

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. The majority of patients achieve sufficient LDL-C reduction with the 75 mg dosage.1
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 convenience3

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.3

NEED HELP? CONTACT A REP

Learn more about flexible dosing options from a PRALUENT Field Representative

HELP KEEP PATIENTS ON TRACK

Learn how MyPRALUENT® Patient Services can support your patients

Learn how MyPRALUENT® Patient Services can support your patients

HELP PATIENTS GET PRALUENT

Get help with prior authorization, coverage information, and more

Get help with prior authorization, coverage information, and more

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 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 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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References:
  1. PRALUENT® (alirocumab) Prescribing Information. Sanofi and Regeneron Pharmaceuticals.
  2. Roth EM, Bujas-Bobanovic M, Louie MJ, Cariou B. Patient and physician perspectives on mode of administration of the PCSK9 monoclonal antibody alirocumab, an injectable medication to lower LDL-C levels. Clin Ther. 2015;37:1945-1954.
  3. Tatlock S, Arbuckle R, Sanchez R, et al. Psychometric evaluation of a treatment acceptance measure for use in patients receiving treatment via subcutaneous injection. Value Health. 2017;20:430-440.

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SAUS.PRL.19.02.1357d Last Update: May 2019

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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 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