Praluent Injection, Solution
Product Images NDC 0024-5901

Product Visual Gallery

This gallery contains 37 technical images submitted to the FDA as part of the official labeling for Praluent (NDC 0024-5901). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sanofi-aventis U.s. Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Figure 1 (Praluent 01)

A line graph comparing the cumulative incidence of events over 48 months between placebo and Praluent, showing a lower incidence for Praluent. The x-axis indicates time in months, and the y-axis shows the cumulative incidence. The chart includes hazard ratio data (0.85, 95% CI 0.78 to 0.93) and the number of subjects at risk at several time points for both groups.*

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Figure 2 (Praluent 02)

Line graph showing LDL-C least squares mean percent change from baseline over 52 weeks comparing Praluent and placebo groups. The x-axis represents time points in weeks, while the y-axis shows percent change in LDL-C. Praluent group exhibits a significant decrease reaching about -58% at 24 weeks and -52% at 52 weeks, whereas placebo remains near baseline with minimal change. Participant numbers at baseline, week 24, and week 52 are provided for both groups.*

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Figure 3 (Praluent 03)

A line graph comparing the mean percent change in LDL-C from baseline over 52 weeks between PRALUENT and placebo groups. The x-axis represents time in weeks, and the y-axis shows LDL-C percent change. PRALUENT consistently reduces LDL-C by about 46-47%, while placebo shows minimal change near 7-8%. The graph includes sample sizes for each time point for both groups.*

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Figure 4 (Praluent 03a)

A line graph depicting the mean percent change from baseline in LDL-C levels over 12 weeks. The graph compares three groups: Placebo, Praluent 75 mg every 2 weeks, and Praluent 300 mg every 4 weeks, showing noticeable decreases in LDL-C for both Praluent dosages relative to placebo over time.*

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Figure 5 (Praluent 03b)

A line graph showing LDL-C LS mean percent change from baseline over 12 weeks. It compares Praluent 150 mg every 2 weeks and placebo groups, with Praluent showing a decrease to -27% and placebo showing a slight increase of 9% at 12 weeks.*

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Figure (Praluent 04)

An instructional diagram of the Praluent 75 mg/mL prefilled pen, showing labeled parts including the green button, body with the product name and strength, a window, a yellow safety cover indicating the needle inside, and a blue cap. The diagram notes it is for single use only.*

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Figure (Praluent 05)

Praluent 75 mg/mL vial label showing the proprietary name, active ingredient alirocumab at 75 mg/mL, with a color-coded green and white design. The label includes the Rx ONLY designation and is from Sanofi-Aventis U.S. LLC.*

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Figure (Praluent 06)

An instructional illustration showing a close-up of a device labeled 'A' with a green check mark, indicating a correct step or condition, possibly related to the use or activation of a Praluent injection device.*

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Figure (Praluent 07)

An instructional diagram showing a device window labeled with the letter B, containing a yellow vertical indicator bar crossed out by a red X. This image likely indicates a condition or step to avoid when inspecting or using the device.*

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Figure (Praluent 08)

An illustration of a round timer graphic showing a 30-40 minute time interval highlighted. The timer is segmented, with the 30-40 minute portion distinctly colored in orange, representing a time duration range.*

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Picture A (Praluent 09)

Illustration showing recommended injection sites for Praluent on the human body. Highlighted areas include the outer upper arms, abdomen (excluding a 2-inch area around the navel), and the front and outer thighs. These sites are commonly used for subcutaneous injection of Praluent 150 mg/mL or 75 mg/mL.*

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Figure B (Praluent 10)

An instructional illustration showing a hand holding the Praluent autoinjector and another hand removing the blue cap from the device, indicated by an orange arrow pointing left and labeled 'Blue cap.' This image guides users on preparing the autoinjector before use.*

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Figure (Praluent 11)

Illustration showing a hand gripping a Praluent autoinjector device. The device is predominantly white with a green cap, used for subcutaneous injection of Praluent, a medication labeled by Sanofi-Aventis U.S. LLC.*

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Figure (Praluent 12)

An instructional illustration showing how to properly hold and use the Praluent injection pen. It depicts a hand holding the pen vertically at a 90-degree angle with an arrow pointing down to indicate injection direction. Two smaller insets demonstrate the correct and incorrect positioning of the pen tip during injection, with a green checkmark for correct placement and a red X for incorrect placement.*

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Figure (Praluent 13)

An instructional illustration showing a hand pressing a green button on a device labeled with a downward arrow, then releasing the button with an upward arrow. A text box below instructs to "Release the button immediately." The image appears to demonstrate a step in using the Praluent drug delivery device.*

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Figure (Praluent 14)

An instructional illustration showing a hand holding a Praluent auto-injector pen. The image includes a circular timer icon indicating 20 seconds and an arrow pointing downward, likely demonstrating the proper injection time and technique for holding the device during administration.*

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Figure (Praluent 15)

An illustration showing a portion of a Praluent prefilled pen injector with a yellow indicator visible through a transparent window. A graphic starburst with the word "click!" indicates an audible click feature, likely during use. The image focuses on the user interface of the pen device rather than the medication label itself.*

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Figure (Praluent 16)

An instructional illustration showing a hand holding a Praluent injection pen with the needle tip pressed against the skin, indicating the start of a subcutaneous injection.*

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Figure (Praluent 17)

An instructional illustration showing a hand holding a Praluent prefilled pen with a yellow dosage window, positioned above a container with an open blue cap. The image demonstrates the step of pressing the pen into the container, indicated by an orange downward arrow, likely part of the preparation or disposal process for the injection system.*

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Figure (Praluent 18)

An instructional diagram depicting a Praluent injection pen labeled with strength 150 mg/mL. The diagram highlights various parts of the pen including the gray button, body, window, yellow safety cover indicating the needle inside, and a blue cap. The yellow safety cover is noted as for single use only.*

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Figure (Praluent 19)

Praluent 150 mg/mL injection vial label featuring the proprietary name Praluent and the active ingredient alirocumab. The label identifies the concentration as 150 mg/mL and includes the note Rx Only. The labeler is Sanofi-Aventis U.S. LLC.*

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Figure (Praluent 20)

An illustration showing a close-up view of a Praluent (alirocumab) injection pen. The image highlights a specific area on the pen with a checkmark, indicating a correct position or step in the injection process.*

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Figure (Praluent 21)

An instructional illustration depicting a close-up view of a portion of a device or pen with a yellow colored indicator inside a window. A red X mark is shown near the yellow area, indicating an incorrect or undesirable condition.*

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Figure (Praluent 22)

An illustration of a clock face highlighting a 30-40 minute time interval, indicated by an orange shaded sector covering this duration with the text '30-40 minutes' inside the shaded area. The image suggests a timing or waiting period related to the product Praluent.*

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Picture A (Praluent 23)

An instructional illustration showing areas of the human body suitable for subcutaneous injection. Highlighted sites include the front and outer sides of the thighs, the abdomen around the navel but avoiding the immediate navel area, and the outer upper arms.*

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Figure B (Praluent 24)

An instructional illustration showing a hand holding a Praluent injection pen while the other hand removes the blue cap from the pen. An orange arrow indicates the direction to pull the cap away from the pen.*

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Figure (Praluent 25)

An instructional illustration showing a hand gripping a Praluent injection pen. The pen is held with the thumb positioned near the top, likely demonstrating the proper grip or injection technique for this Praluent (alirocumab) 150 mg/mL or 75 mg/mL prefilled pen by Sanofi-Aventis.*

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Figure (Praluent 26)

An instructional illustration showing how to hold a Praluent injection pen at a 90-degree angle to the skin for proper injection. It includes a hand gripping the pen with arrows indicating downward pressure and inset images demonstrating the correct and incorrect needle insertion angles.*

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Figure (Praluent 27)

An instructional illustration demonstrating the use of a Praluent (alirocumab) injection device. It shows hands pressing a button on the device, with arrows indicating downward and upward motions and a 'click!' sound effect. A highlighted yellow box instructs to 'Release the button immediately.' This diagram helps users understand how to operate the injection pen.*

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Figure (Praluent 28)

An instructional illustration shows a hand holding a Praluent injection pen with an arrow pointing downward to the injection site on the skin. A clock icon indicates to hold the injection in place for 20 seconds, demonstrating the proper subcutaneous injection technique for this medication.*

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Figure (Praluent 29)

An instructional illustration showing part of a device with a vertical yellow indicator bar and a label 'click!' indicating a mechanism engagement or activation.*

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Figure (Praluent 30)

Illustration showing a hand holding a Praluent injection pen with the cap removed, positioned for subcutaneous injection. An arrow indicates pressing the pen against the skin to administer the medication.*

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Figure (Praluent 31)

An instructional illustration showing a hand holding a Praluent single-dose pen and inserting its tip into a vial or container. The image demonstrates the initial step in preparing the Praluent injection device for use.*

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Principal Display Panel (75 mg/mL Pen Carton)

Praluent alirocumab 75 mg/mL injection carton for one pre-filled pen. The packaging is primarily green and white, displaying the active ingredient name, strength, and dosage form. It is labeled for subcutaneous injection, single-dose, and produced by Sanofi-Aventis U.S. LLC in collaboration with Regeneron. The carton includes instructions to open and a barcode visible on one side.*

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Principal Display Panel (150 mg/mL Pen Carton)

Praluent alirocumab Injection 150 mg/mL label for one pre-filled pen. The packaging states it is for subcutaneous injection only and single-dose. It shows usage instructions references and includes the manufacturers Regeneron and Sanofi. The label displays strength prominently in white text on a blue background along with the NDC 0024-5902-01 and bar code. The Sanofi-Aventis U.S. LLC labeler information is included.*

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Principal Display Panel (75 mg/mL Syringe Carton)

Praluent alirocumab Injection 75 mg/mL carton label for one pre-filled syringe. The packaging includes branding by Sanofi and Regeneron, mentions single-dose subcutaneous injection, and provides storage and handling instructions. The label shows the NDC code 0024-5903-01 and features a QR code for additional information.*

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Principal Display Panel (150 mg/mL Syringe Carton)

Praluent 150 mg/mL injection carton label for a single-dose, pre-filled syringe containing alirocumab. The label indicates the product is for subcutaneous injection only and includes storage instructions and manufacturer details for Sanofi-Aventis U.S. LLC. The packaging features the Praluent and Sanofi logos and a QR code for more information.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.