For U.S. Healthcare Professionals Only

Instructions for Use:

75 mg Pen 150 mg Pen

MyPRALUENT® Patient Support

Designed to help your patients start and stay on track

~25% more patients refilled their PRALUENT prescriptions at 12 months when enrolled in

MyPRALUENT® Patient Support Program1*

MyPRALUENT Patient Support provides your patients on PRALUENT a wide range of support and tools

Helps patients get started

  • Nurse phone support 7 days a week
  • On-demand injection training video
  • Sharps disposal container

Helps eligible patients with the cost

  • As little as $0 copay offer for eligible commercially insured patients†‡

Helps patients build a routine

  • Dedicated one-on-one nurse phone support
  • Injection reminders via text messages and free reminder magnet
  • Ongoing resources including educational emails and a travel kit

*Based upon an analysis of prescription fill data from September 2017, measured from date of first dispense to date of last dispense + corresponding days of supply. The refill rate for patients enrolled in MyPRALUENT was 42% and the comparator group was 34%.
Eligible patients with commercial insurance not funded through a government healthcare program such as Medicare, Medicaid, or TRICARE subject to program terms and restrictions.
Subject to a maximum annual copay assistance amount from MyPRALUENT of $5,500.

NEED HELP? CONTACT A REP

Learn more about support available through MyPRALUENT Patient Support

IMPORTANT INFORMATION TO HELP YOUR PATIENTS GET STARTED ON PRALUENT

  • Let your patients know that the insurance approval process may take some time
  • Instruct your patients to follow up with your office and their insurance provider to check on the status of their prescription
  • Tell your patients the name and number of their pharmacy, and let them know that the pharmacy may call to schedule delivery or pickup
  • Remind your patients that the pharmacy may call regularly to refill their prescription

WHAT PATIENTS CAN EXPECT WHEN RECEIVING PRALUENT

Encourage your patients to sign up for support:

PRALUENT.com/registration or 1-844-PRALUENT (1-844-772-5836), option 1

VIEW COPAY OFFER

Get a Copay Card for your eligible commercially insured patients

Get a Copay Card for your eligible commercially insured patients

PRALUENT ACCESS & AFFORDABILITY

Help your patients with accessibility, affordability & dosing flexibility

Help your patients with accessibility, affordability & dosing flexibility

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 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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Reference:
  1. Data on file. Sanofi and Regeneron.

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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