Wainua Injection, Solution
Product Images NDC 0310-9420

22 FDA label images from Astrazeneca Pharmaceuticals Lp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Wainua (NDC 0310-9420). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Astrazeneca Pharmaceuticals Lp, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure_1 (Figure 1)

Figure_1 (Figure 1)
A line graph comparing the LS Mean (SEM) change from baseline in mNIS+7 scores over 35 weeks between WAINUA and placebo groups. The x-axis represents time from baseline to week 35, while the y-axis shows the change in scores. WAINUA maintains a near-zero change, whereas placebo shows an increase. Sample sizes at week 35 are 140 for WAINUA and 59 for placebo.*
FDA Label Image

Chemical_structure (Chemical Structure)

Chemical_structure (Chemical Structure)
Chemical structure diagram showing the molecular structure of eplontersen, the active ingredient in WAINUA injection, solution. The diagram depicts the nucleotide sequences and chemical bonds characteristic of this compound.*
FDA Label Image

Figure_2 (Figure 2)

Figure_2 (Figure 2)
A bar graph comparing the percent of patients experiencing changes in mNIS+7 scores from baseline at Week 35 for WAINUA versus placebo. The x-axis shows score changes ranging from -90 to +60, along with categories for Death and Missing, while the y-axis represents the percent of patients. Data distinguishes better and worse outcomes with black bars for WAINUA (N=144) and white bars for placebo (N=60).*
FDA Label Image

Figure_3 (Figure 3)

Figure_3 (Figure 3)
A line graph comparing the change from baseline in Norfolk QOL-DN total score over 35 weeks between WAINUA 45 mg subcutaneous injection and placebo groups. The graph shows a decrease in score for WAINUA and an increase for placebo, with sample sizes of 133 for WAINUA and 58 for placebo at both baseline and week 35.*
FDA Label Image

Figure_4 (Figure 4)

Figure_4 (Figure 4)
A bar chart comparing percentage of patients showing Norfolk QOL-DN total score change from baseline at Week 35 between WAINUA and placebo groups. The x-axis shows score change categories ranging from -70 to +50, death, and missing data. The y-axis shows percent of patients. Bars represent better (negative scores) and worse (positive scores) outcomes for WAINUA and placebo groups.*
FDA Label Image

Figure_5 (Figure 5)

Figure_5 (Figure 5)
A bar chart showing the distribution of Norfolk QOL-DN total score changes from baseline at Week 35 for patients treated with WAINUA (n=144) versus placebo (n=60). The x-axis represents score changes ranging from -70 to >50, with annotations indicating 'Better' for negative changes and 'Worse' for positive. The y-axis indicates the percentage of patients, with separate bars for WAINUA and placebo groups across various score change categories, including death and missing data.*
FDA Label Image

Picture 1 (Picture 1)

Picture 1 (Picture 1)
Illustration showing the WAINUA (eplontersen) injection pen before and after use. Before use, the pen has a cap, a viewing window indicating the liquid medicine inside, and a capped end. After removal of the cap, the diagram shows the orange needle guard concealing the needle, the orange plunger, and the protective sleeve inside the removed cap.*
FDA Label Image

Picture 2 (Picture 2)

Picture 2 (Picture 2)
Illustration showing the contents included and not included with the WAINUA autoinjector for subcutaneous injection. Included is one autoinjector in a carton from the refrigerator. Not included are one alcohol wipe, one cotton ball or gauze, one small bandage, and one puncture-resistant sharps disposal container.*
FDA Label Image

Picture 3 (Picture 3)

Picture 3 (Picture 3)
An illustration of a stopwatch or timer showing 30 minutes, with the last half of the timer bar shaded in green. This likely represents a 30-minute duration or waiting period.*
FDA Label Image

Picture 4 (Picture 4)

Picture 4 (Picture 4)
An instructional illustration showing a hand holding a WAINUA injection pen with a visible window labeled 'Check' and a panel indicating where the lot number and expiration date are displayed. The image highlights the proper way to verify the injection pen before use.*
FDA Label Image

Picture 5 (Picture 5)

Picture 5 (Picture 5)
An anatomical diagram for injection site guidance shows areas suitable for subcutaneous injection of WAINUA (Eplontersen). It highlights the abdomen and thigh as appropriate sites for all patients and the back of the upper arm as an injection site for caregivers only.*
FDA Label Image

Picture 6 (Picture 6)

Picture 6 (Picture 6)
A two-panel instructional illustration showing hand hygiene steps. The left panel depicts washing hands under a faucet with water splashing. The right panel shows a hand drying or wiping with a cloth or paper towel.*
FDA Label Image

Picture 7 (Picture 7)

Picture 7 (Picture 7)
An instructional illustration showing how to remove the protective sleeve from a subcutaneous injection device containing WAINUA (eplontersen). The diagram highlights the orange needle guard, indicating the needle is hidden inside the guard, with arrows demonstrating the removal direction.*
FDA Label Image

Picture 8 (Picture 8)

Picture 8 (Picture 8)
An instructional illustration depicting the proper hand position to hold a prefilled injection pen at a 90-degree angle to the skin. The illustration highlights a 'viewing window' on the pen for visibility during administration.*
FDA Label Image

Picture 9 (Picture 9)

Picture 9 (Picture 9)
Illustrated instructions for subcutaneous injection using an auto-injector for WAINUA (eplontersen) 45 mg/.8mL. Steps show pressing the device down firmly at a 90-degree angle, holding for 10 seconds until the orange plunger fills the viewing window with audible clicks, and then lifting the auto-injector straight up to lock the orange needle guard over the needle.*
FDA Label Image

Picture 11 (Picture 11)

Picture 11 (Picture 11)
An instructional illustration showing a pre-injection and post-injection state of a subcutaneous injection device. The left image labeled "Before injection" shows the device with a clear window, and the right image labeled "After injection" shows the window filled with an orange indicator, demonstrating the change after use.*
FDA Label Image

Picture 10 (Picture 10)

Picture 10 (Picture 10)
An instructional illustration showing a hand holding a WAINUA injection pen. The pen is white with an orange cap and a visible dose indicator window marked with the strength 45 mg/0.8 mL, used for subcutaneous administration of EPLONTERSEN.*
FDA Label Image

Picture 12 (Picture 12)

Picture 12 (Picture 12)
An illustration showing a hand pinching the skin on the forearm, likely demonstrating the technique for a subcutaneous injection.*
FDA Label Image

Picture 13 (Picture 13)

Picture 13 (Picture 13)
An instructional illustration showing a hand holding a prefilled injection pen, positioned above a sharps disposal container for safe discarding. The injection pen is marked with an orange label and a brown cap, indicating it is ready for disposal after use.*
FDA Label Image

Carton_label_45mg_per_0_8ml (Carton Label 45mg Per 0 8ml)

Carton_label_45mg_per_0_8ml (Carton Label 45mg Per 0 8ml)
Packaging label for WAINUA (eplontersen) injection 45 mg/0.8 mL, a subcutaneous injection solution. The label indicates it is for single-dose use with each autoinjector containing 45 mg eplontersen in 0.8 mL. The manufacturer is AstraZeneca Pharmaceuticals LP. The label includes storage instructions and a panel with simplified instructions for use, showing how to operate the autoinjector device.*
FDA Label Image

Carton_pfs_label_45mg_per_0_8ml (Carton Pfs Label 45mg Per 0 8ml)

Carton_pfs_label_45mg_per_0_8ml (Carton Pfs Label 45mg Per 0 8ml)
WAINUA 45 mg/0.8 mL injection, solution for subcutaneous use containing eplontersen, displayed as a single-dose prefilled syringe packaging. The label includes dosage and administration details, the AstraZeneca Pharmaceuticals LP and Ionis logos, and a syringe illustration. The product is marked Rx only and features safety instructions and barcode.*
FDA Label Image

Container_pfs_label_45mg_per_0_8ml (Container Pfs Label 45mg Per 0 8ml)

Container_pfs_label_45mg_per_0_8ml (Container Pfs Label 45mg Per 0 8ml)
Label for WAINUA (eplontersen) injection, 45 mg/0.8 mL, a subcutaneous solution. The label includes the product name, strength, dosage form, subcutaneous use indication, a barcode, lot and expiration date placeholders, and the labeler AstraZeneca Pharmaceuticals LP.*

* 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.