Nemluvio Injection, Powder, Lyophilized, For Solution
Product Images NDC 0299-6220

Product Visual Gallery

This gallery contains 23 technical images submitted to the FDA as part of the official labeling for Nemluvio (NDC 0299-6220). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Galderma Laboratories, L.p., 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-a (Figure A)

An illustration showing a carton labeled NEMLUVIO being removed from a refrigerator, with an accompanying clock indicating 30-45 minutes. The image instructs to let NEMLUVIO come to room temperature before use.*

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30g-pen-carton (Pxxxxx X Nemo Ai Carton 30mg Fda 8.9)

NEMLUVIO 30 mg injection powder, lyophilized, for solution, in a single-dose pre-filled dual-chamber pen for subcutaneous use. The label shows the proprietary name NEMLUVIO, generic name nemolizumab-ilto, and labeler Galderma Laboratories, L.P. Instructions note refrigeration storage, no freezing, and use within 4 hours after reconstitution. The packaging includes barcode and lot details area, with handling and disposal warnings.*

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Device-overview (Device Overview)

Illustration showing the NEMLUVIO single-dose pre-filled dual-chamber pen before and after use. The diagram highlights key device components including the gray cap, inspection window, lyophilized powder chamber, activation knob, needle cover, orange needle guard, gray rod, and orange rod. It notes normal appearance changes after injection, such as partial window coverage by the orange rod and unlock icon on the activation knob.*

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Figure-1 (Figure 1 July22)

A line graph showing the proportion of subjects with weekly average PP NRS improvement of at least 4% over 16 weeks. The graph compares four groups: NEMLUVIO Q4W in Olympia 1 and 2 trials, and their respective placebo groups. NEMLUVIO groups reach around 50% improvement by week 16, while placebo groups remain below 20%. The x-axis is labeled weeks and the y-axis is percentage improvement.*

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Figure-3 (Figure 3 July22)

A line graph showing the proportion of subjects with IGA success (%) over 16 weeks in two clinical trials (Olympia 1 and Olympia 2). Four groups are represented: NEMLUVIO Q4W and placebo in each study. NEMLUVIO groups show increasing success rates, reaching 26% and 38% at week 16, while placebo groups remain lower at 7% and 11%. The x-axis represents weeks, and the y-axis represents the percentage of subjects with IGA success.*

FDA Label Image

Figure-b (Figure B)

An instructional illustration showing a hand holding a vial or syringe, with a droplet or liquid being drawn or injected. The image is labeled as 'Figure B' and includes a green exclamation mark icon, indicating an important step or caution in the procedure.*

FDA Label Image

Figure-c (Figure C)

Illustration showing four labeled components related to injection preparation: 1) a device with an attached syringe and a cap labeled in part, 2) a small square object resembling a vial or sachet, 3) a cup with a stirring stick or spoon, and 4) a small round object, possibly a tablet or pellet. This figure appears to guide steps for preparing or administering a subcutaneous injection of a lyophilized powder for solution.*

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Figure-d (Figure D)

Illustration labeled Figure D showing a subcutaneous injection device for NEMLUVIO with annotated parts identifying the lyophilized powder section and the expiration date window.*

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Figure-e (Figure E)

Illustration labeled Figure E showing a hand unlocking a device by turning a component clockwise. The inset circle highlights an unlock icon on the device indicating the unlocked position.*

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Figure-f (Figure F)

An instructional figure labeled 'Figure F' showing two views of a small vial or cartridge for injection powder. The 'Before' image shows the vial with a gray rod inside, while the 'After' image shows the vial without the gray rod, indicating a step in the preparation or use process for the drug Nemluvito, a lyophilized powder for subcutaneous injection.*

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Figure-g (Figure G)

An instructional illustration showing the proper shaking technique for a subcutaneous injection device. It advises to shake the device up and down for 30 seconds, with a clock icon indicating the time duration.*

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Figure-h (Figure H)

An instructional figure showing the process of dissolving the NEMLUVIO lyophilized powder for injection. It depicts a vial with undissolved powder marked with a red X, a clock indicating a 5-minute wait, and a vial with fully dissolved solution marked with a green check. A syringe is shown ready for subcutaneous administration.*

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Figure-i (Figure I)

An instructional diagram illustrating the dissolution status of the product, showing an eye looking at a vial with a magnified view indicating the vial contents are fully dissolved, accompanied by a green check mark and the label 'Dissolved'.*

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Figure-j (Figure J)

Illustration showing recommended injection sites for NEMLUVIO (nemolizumab-ilto) subcutaneous injection. For self-injection, the abdomen (2 inches away from the navel) and upper thigh are highlighted. For injection by a caregiver, the abdomen, upper thigh, and outer upper arm are indicated as suitable sites.*

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Figure-k (Figure K)

Illustration labeled Figure K showing a hand holding an alcohol wipe, presumably to be used for cleaning skin prior to injection.*

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Figure-l (Figure L)

An instructional diagram showing three steps to remove a cap from a vial or device. Step a instructs to hold the vial upright. Step b shows twisting the cap. Step c illustrates pulling off the cap. A warning indicates not to pull the gray cap directly.*

FDA Label Image

Figure-m (Figure M)

An instructional illustration showing how to hold and use a NEMLUVIO injection device. It depicts a hand gripping the device near the top, with the orange needle guard visible at the bottom and the injection site indicated below the needle guard.*

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Figure-n (Figure N)

An instructional diagram showing how to start the injection for a subcutaneous drug product. It depicts a hand holding an injection device labeled with an orange rod and gray rod. Instructions indicate to push down on the orange needle guard to start the injection, accompanied by a clicking sound.*

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Figure-o (Figure O)

An instructional diagram showing a hand holding a syringe with labeled orange and gray rods inside the barrel. The diagram includes a timer indicating 15 seconds and instructs to hold the syringe and slowly count to 15, likely illustrating the injection or preparation technique.*

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Figure-p (Figure P)

An instructional illustration showing a hand holding a subcutaneous injection device labeled with an orange needle guard. The diagram includes an upward arrow and text instructing to "Lift straight up," indicating the correct removal technique for the needle guard before injection.*

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Figure-q (Figure Q)

Illustration showing a subcutaneous injection pen being removed from a red sharps disposal container with a gray cap beside it. The figure is labeled 'Figure Q' and highlights safe disposal of the injection pen and cap.*

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Figure-2 (Figure2 July22)

Line graph showing the proportion of subjects with weekly average patient-reported Numerical Rating Scale (NRS) scores less than 2 over 16 weeks. The graph compares NEMLUVIO (nemolizumab-ilto) Q4W treatment in two studies, Olympia 1 and Olympia 2, against placebo groups. The NEMLUVIO groups show a higher percentage reaching under 2 NRS scores compared to placebo throughout the period.*

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Turn-over (Turn Over)

An instructional graphic with a purple background and white text instructing the viewer to turn over the material to read about pen disposal and frequently asked questions (FAQs). A right-pointing arrow is also shown.*

* 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.