These Highlights Do Not Include All The Information Needed To Use Nemluvio Safely And Effectively. See Full Prescribing Information For Nemluvio.

Adult Patients Weighing Less Than 90 kg:

The recommended subcutaneous dosage of NEMLUVIO for adult patients weighing less than 90 kg is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.



Adult Patients Weighing 90 kg or More:

The recommended subcutaneous dosage of NEMLUVIO for adult patients weighing 90 kg or more is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks.

PATIENT INFORMATION

NEMLUVIO® [Nem LOO vee oh]

(nemolizumab-ilto)

for injection, for subcutaneous use

What is NEMLUVIO?

NEMLUVIO is a prescription medicine used:

• to treat adults with prurigo nodularis. 
• to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical). NEMLUVIO can be used with certain prescription topical medicines.

It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age.

It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age.

Do not take NEMLUVIO  if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. See the end of this Patient Information leaflet for a complete list of ingredients in NEMLUVIO.

Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

• are scheduled to receive any vaccination. You should avoid receiving a live vaccine right before or during treatment with NEMLUVIO.
• are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby. 
• are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take NEMLUVIO?

• See the detailed Instructions for Use that comes with NEMLUVIO for information on how to prepare and inject NEMLUVIO and how to properly store and throw away (dispose of) used NEMLUVIO prefilled pens. 
• Use NEMLUVIO exactly as prescribed by your healthcare provider. 
• Use NEMLUVIO with prescription topical therapies. When your eczema has sufficiently improved, your healthcare provider may discontinue topical therapies. 
• Your healthcare provider will tell you how much NEMLUVIO to inject and how often to inject it. 
• NEMLUVIO comes as a single-dose prefilled pen with a needle guard. 
• NEMLUVIO is given as an injection under the skin (subcutaneous injection). 
• If your healthcare provider decides that you or a caregiver can give the injections of NEMLUVIO, you or your caregiver should receive training on the right way to prepare and inject NEMLUVIO. Do not try to inject NEMLUVIO until you have been shown the right way by your healthcare provider. 
• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time. 
• If you inject too much NEMLUVIO, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. 
• Your healthcare provider may prescribe other medicines to use with NEMLUVIO. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What should I avoid while taking NEMLUVIO?

You should avoid receiving live vaccines while taking NEMLUVIO.

What are the possible side effects of NEMLUVIO?

NEMLUVIO may cause serious side effects, including:

• allergic reactions (hypersensitivity). NEMLUVIO can cause allergic reactions that can sometimes be serious. Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

The most common side effects of NEMLUVIO in people treated for prurigo nodularis include:

• headache
• skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)

The most common side effects of NEMLUVIO in people treated for atopic dermatitis include:

• headache
• joint pain
• hives (itchy red rash or wheals)
• muscle aches

These are not all of the possible side effects of NEMLUVIO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store NEMLUVIO?

• Store NEMLUVIO in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date. 
• Store NEMLUVIO in the original carton to protect from light. 
• NEMLUVIO can be stored at room temperature up to 77ºF (25ºC) for a single period up to 90 days.
• Throw away (dispose of) NEMLUVIO after the expiration date and any NEMLUVIO that has been left at room temperature for longer than 90 days. 
• After the NEMLUVIO lyophilized powder and water for injection are mixed (reconstituted), NEMLUVIO must be used within 4 hours or thrown away (discarded). 
• Do not heat or put NEMLUVIO pen into direct sunlight. 
• Do not freeze the NEMLUVIO pen. 
• If the NEMLUVIO pen was heated or frozen, throw it away (dispose of it).

Keep NEMLUVIO and all medicines out of the reach of children.

General information about the safe and effective use of NEMLUVIO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NEMLUVIO for a condition for which it was not prescribed. Do not give NEMLUVIO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NEMLUVIO that is written for healthcare professionals.

What are the ingredients in NEMLUVIO?

Active ingredient: nemolizumab-ilto

Inactive ingredients: arginine hydrochloride, poloxamer 188, sucrose, trometamol, and tris hydrochloride.

Manufactured by: Galderma Laboratories, L.P., Dallas, TX 75201

U.S. License No. 2289

NEMLUVIO^® is a registered trademark of Galderma.

© 2025 Galderma Laboratories, L.P. All rights reserved.

For more information, go to www.NEMLUVIO.com or call 1-866-735-4137.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 06/2025

NEMLUVIO is indicated for the treatment of adults with prurigo nodularis.

There is no specific treatment for NEMLUVIO overdosage. In the event of overdosage, contact Poison Control (1-800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

Risk Summary

Available data on NEMLUVIO use in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an enhanced pre- and postnatal development study in cynomolgus monkeys, when nemolizumab-ilto was administered subcutaneously during organogenesis to parturition, an increase in early postnatal death was observed at a dose 36 times the maximum recommended human dose (MRHD) for PN and 50 times for AD (see Data). The clinical significance of this nonclinical finding is unknown.



The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Risk Summary

There are no data on the presence of nemolizumab-ilto in human milk, the effects on the breastfed infant, or the effects on milk production. Nemolizumab-ilto was detected in breast milk of monkeys (see Data). Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to nemolizumab-ilto are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from the underlying maternal condition.

Nemolizumab-ilto, an interleukin-31 receptor alpha (IL-31RA) antagonist, is a humanized monoclonal modified immunoglobulin G (IgG) antibody with a molecular weight of approximately 144 kDa. Nemolizumab-ilto is produced by recombinant DNA technology in Chinese Hamster Ovary cells.

NEMLUVIO (nemolizumab-ilto) for injection is a sterile, preservative-free, white lyophilized powder in a dualchamber, single-dose, prefilled pen for subcutaneous use. One chamber contains 30 mg of nemolizumab-ilto with inactive ingredients arginine hydrochloride (9.5 mg), poloxamer 188 (0.15 mg), sucrose (25.8 mg), trometamol (0.10 mg), and tris hydrochloride for pH adjustment. The diluent, water for injection, is in the other chamber. Following reconstitution, each prefilled pen delivers 30 mg/0.49 mL of nemolizumab-ilto with a pH of 6.7 to 7.3.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. Avoid use of live vaccines in patients during treatment with NEMLUVIO. It is unknown if administration of live vaccines during NEMLUVIO treatment will impact the safety or effectiveness of these vaccines. No data are available on the response to non-live vaccines.

Prurigo Nodularis

The safety and effectiveness of NEMLUVIO have not been established in pediatric patients.

Atopic Dermatitis

The safety and effectiveness of NEMLUVIO for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors have been established in pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies. Use of NEMLUVIO for this indication is supported by evidence from two randomized, double-blind, placebo-controlled trials [See Adverse Reactions (6.1) and Clinical Studies (14.2)].



The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age.

Prurigo Nodularis

Of the 370 subjects with prurigo nodularis exposed to NEMLUVIO in OLYMPIA 1 and OLYMPIA 2, 99 (26.8%) subjects were 65 years of age or older. The long-term safety of NEMLUVIO was assessed in 508 subjects, among which 133 (26.2%) were 65 years of age or older. Clinical trials of NEMLUVIO did not include sufficient numbers of subjects 65 years of age or older to determine whether they respond differently than younger adult subjects. [see Clinical Pharmacology (12.3)].

Atopic Dermatitis

Of the 1192 subjects with atopic dermatitis exposed to NEMLUVIO in the primary safety population, 72 (6.0%) subjects were 65 years of age or older. The long-term safety of NEMLUVIO was assessed in 78 (4.5%) subjects 65 years of age or older. Clinical studies of NEMLUVIO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects [see Clinical Pharmacology (12.3)].

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of nemolizumab-ilto or other nemolizumab products.

Prurigo Nodularis:

• In the Phase 3 trials (OLYMPIA 1, OLYMPIA 2) up to 24 weeks, the incidence of treatment-emergent ADAs was 7%; neutralizing antibodies were seen in 3% of subjects.

Atopic Dermatitis:

• In the phase 3 trials (ARCADIA 1, ARCADIA 2) up to 16 weeks, the incidence of treatment-emergent ADAs was 6.1% (67/1092). Among subjects who continued treatment from week 16 through week 48 in the two studies, the ADA incidence was 13.9% (23/166) for those that received 30 mg every 4 weeks, and 10.6% (17/161) for those that received 30 mg every 8 weeks. Neutralizing antibody incidence was 4.5% (3/67) among the ADA+ subjects throughout 48 weeks in ARCADIA 1 and ARCADIA 2, respectively.

Anti-Drug Antibody Effects on Pharmacokinetics and Pharmacodynamics

• Prurigo Nodularis: In the phase 3 trials in subjects with prurigo nodularis, there was no identified clinically significant effect of anti-drug antibodies on the pharmacokinetics, safety or efficacy of nemolizumab-ilto over the treatment duration of 24 weeks. 
  
  
  
  
• Atopic Dermatitis: In the phase 3 trials in subjects with atopic dermatitis, antibodies to nemolizumab-ilto were associated with reduced serum nemolizumab-ilto concentrations beyond Week 16. NEMLUVIO treated subjects who developed ADAs had nemolizumab-ilto concentrations that were 20% to 70% lower compared to subjects who did not develop ADAs. There was no clinically significant effect of anti-drug antibodies on safety or efficacy of nemolizumab-ilto over the treatment duration of 48 weeks.

NEMLUVIO is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO [see Warnings and Precautions (5.1)].

The following clinically significant adverse reactions are described in greater details elsewhere in the labeling:

• Hypersensitivity [see Warnings and Precautions (5.1)]

Hypersensitivity reactions, such as facial angioedema, have been reported with use of NEMLUVIO. NEMLUVIO is contraindicated in patients with a known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO [see Contraindications (4), Adverse Reactions (6.1)].

NEMLUVIO® [Nem LOO vee oh]

(nemolizumab-ilto)

for injection, for subcutaneous use 

This Instructions for Use contains information on how to inject NEMLUVIO.



Read and understand these instructions before using the NEMLUVIO pen.



Do not inject yourself or someone else until you have been instructed how to inject NEMLUVIO.



In adolescents (ages 12 to 17 years old), it is recommended that NEMLUVIO be given by or under supervision of a trained adult or caregiver.



Your healthcare provider will instruct you or your caregiver how to prepare and inject a dose of NEMLUVIO before you try to do it yourself the first time. Call your healthcare provider if you have any questions.



NEMLUVIO is supplied as a single-dose pen (called NEMLUVIO pen or pen in these instructions). It contains medicine (30 mg of lyophilized powder) in one chamber and water for dissolving the medicine in the other chamber. Before you can inject it, you must mix the lyophilized powder with the water for dissolving the medicine.

Important Information



What you need to know before using the NEMLUVIO pen:

• Read all the instructions carefully before using the NEMLUVIO pen.
• Mark your calendar ahead of time to remember when to take NEMLUVIO. 
• Do not use the NEMLUVIO pen if it has been dropped on a hard surface or is damaged, cracked or broken. 
• Follow all steps exactly as described. This makes sure that you get the correct dose of medicine. 
• Make sure that the lyophilized powder is completely dissolved before injecting (Step 9). After dissolving the powder, inject the medicine right away to avoid any contamination or break down of medicine (degradation). 
• To use the pen for injection, while holding upright, gently twist (do not pull) the gray cap to the left (counterclockwise) until the orange needle guard pops up. Then, gently pull the gray cap off the orange needle guard. Do not press the orange needle guard until ready to inject (Step 12). 
• In some cases, your healthcare provider may prescribe 2 pens for a full dose. Use the second NEMLUVIO pen right away after using the first pen. Choose a different injection site at least 1 inch away from the first injection site. 
• To reduce the risk of accidental needle stick injury, each NEMLUVIO pen has an orange needle guard. After injecting the medicine and lifting the pen from your skin, the orange needle guard locks into place automatically to cover the needle (Step 16).
• Throw away (dispose of) the used NEMLUVIO pen right away after use in a sharps disposal container. See Section C: Throwing away (Disposing of) NEMLUVIO below.
  
  

Storage Information:

• Store the NEMLUVIO pen in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date. 
• Store the NEMLUVIO pen in the original carton to protect it from light. 
• The NEMLUVIO pen can be stored at room temperature up to 77°F (25°C) for up to 90 days.
• Throw away (dispose of) the NEMLUVIO pen after the expiration date and any NEMLUVIO pen that has been left at room temperature longer than 90 days. 
• After the NEMLUVIO pen lyophilized powder and water for injection are mixed (reconstituted), the NEMLUVIO pen must be used within 4 hours or thrown away (disposed of). 
• Do not heat or put the NEMLUVIO pen into direct sunlight. 
• Do not freeze the NEMLUVIO pen. 
• If the NEMLUVIO pen was heated or frozen, throw it away (dispose of it).

Keep the NEMLUVIO pen and all medicines out of the reach of children.

Traveling Information:

• Generally, you are allowed to carry pens with you on an airplane. Be sure to carry the NEMLUVIO pens in the original carton with you in your carry-on luggage.
  
  
  
  If you have any other questions refer to the Frequently asked questions (FAQs) on the back of this leaflet.

A. Preparing to inject NEMLUVIO

Step 1: Let NEMLUVIO reach room temperature

Injecting cold medicine might result in pain at the injection site.

Take the NEMLUVIO carton out of the refrigerator and let it come to room temperature for 30 to 45 minutes before starting Step 2 (see Figure A).

Do not:

• warm the pen with any heat source (such as microwave or direct sunlight).  This might damage NEMLUVIO.
• directly expose the pen to liquids.

Step 2: Wash your hands

a. Wash your hands with soap and water to avoid contamination and infection (see Figure B).

b. Dry hands completely.

Step 3: Gather Supplies (see Figure C)

a. Remove the pen from the carton.

b. Gather the following supplies on a clean, flat and well-lit surface:

• Pen
• Alcohol wipes*
• Sharps disposal container*
• Gauze pads or cotton balls*

*Items not included in the carton.



Note: In some cases, your healthcare provider may prescribe 2 pens. Use 1 pen after the other.

Step 4: Check the NEMLUVIO pen for the following:

a. Expiration date has not passed.

b. The lyophilized powder is white and not dissolved (see Figure D).

c. The pen has not been dropped and is not damaged or cracked.

Step 5: Activate the NEMLUVIO pen

Hold the pen upright and unlock the pen by turning the activation knob to the right until it stops (see Figure E).



This starts the process of transferring water to the powder chamber.



Only turn the activation knob to the right once.

Step 6: Wait until the gray rod stops moving

Watch inspection window until gray rod has stopped moving (see Figure F).

Step 7: Dissolve the medicine

When the gray rod has completely stopped, hold the pen upright and shake the pen up and down for 30 seconds (see Figure G).

Step 8: Wait 5 minutes for bubbles to decrease

Wait for bubbles to decrease and the lyophilized powder to dissolve completely. This will take about 5 minutes (see Figure H).

Step 9: Check the medicine in the inspection window

Check to see if the dissolved medicine:

• is clear and colorless to slightly yellow,
• does not contain particles (see Figure I).
  
  
  
  
  

Do not use the pen if the dissolved medicine is cloudy or contains any particles.



Throw away (dispose of) the pen and use a new one (see Section C: Throwing away (Disposing of) NEMLUVIO).



Note: After the medicine has dissolved, it must be used within 4 hours. During this time, it should be kept at room temperature (up to 77°F (25°C)). If you have not used it within 4 hours, throw it away (dispose of it).

B. Injecting NEMLUVIO

Step 10: Select one injection site (see Figure J)



Note: When using a second pen, select a different injection site at least 1 inch away from the first injection site.



Select the injection site using the following chart:

Where not to inject:

• near your waistline within about 2 inches around the navel. 
• into tender, bruised, red skin, or areas with scars or stretch marks. 
• twice into the same site (for example, within 1 inch).

Step 11: Clean the injection site (see Figure K)



a.  Always use a new alcohol wipe to clean the injection site to avoid contamination and infection.

b. Let the skin air dry.

Do not:

• touch the injection site after cleaning.
• fan, or blow air on the cleaned injection site.
• reuse the alcohol wipe.

Step 12: Twist the gray cap



Do not:

• pull the gray cap when twisting to avoid damaging the device.
• touch the orange needle guard.

• Hold the pen upright (see Figure L, a)
• Gently twist the gray cap to the left (counterclockwise) until the orange needle guard pops up (see Figure L, b).
• Gently pull the gray cap off the orange needle guard (see Figure L, c). Do not press on the orange needle guard until ready to inject.
• After cap removal, please throw away (dispose of) the cap in a sharps disposal container (see Step 17).

Note: If the cap cannot be removed, refer back to Step 5 and make sure the activation knob is turned completely to the right until it stops.

Step 13: Place the NEMLUVIO pen

Read Steps 13-16 before starting Step 13.

Note: Always inject the way your healthcare provider showed you.



Place the pen on the injection site vertically so that the orange needle guard is flat against the skin (see Figure M).



Note: Make sure you can easily see the inspection window during injection.

Step 14: Start injection and hold the NEMLUVIO pen on the skin



Gently push the pen down until the orange needle guard is completely pushed in.



The injection starts right away with a click (see Figure N).



The orange rod will begin to move down the injection window.



Do not lift the pen yet and keep pushing down.

Step 15: Inject for 15 seconds



Hold the pen in position and slowly count to 15 or use a timer or clock to count 15 seconds.



Check the inspection window to make sure the orange rod and gray rod have stopped moving (see Figure O).



This means the injection has been completed.



Note: It is normal that the orange rod does not cover the whole inspection window at the end of injection.

Step 16: Lift the NEMLUVIO pen up

a. Lift the pen straight up from your skin.

The orange needle guard automatically locks into place to cover the needle (see Figure P).

    

b. If there is bleeding, press a cotton ball or gauze over the injection site.

C. Throwing away (disposing of) NEMLUVIO

Step 17: Throw away (dispose of) NEMLUVIO in a sharps disposal container



Avoid contact with the needle.



Throw away (dispose of) the used pen and the gray cap in an FDA cleared sharps disposal container right away after use (see Figure Q).

• recap the pen after use,
• dispose of the NEMLUVIO pen and cap in your household trash,
• dispose of your used sharps disposal container in your household trash unless your community guidelines permit this,
• recycle your used sharps disposal container.

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, 
• upright and stable during use,
• leak-resistant and 
• properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.

There may be state or local laws about how you should dispose of used pens.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:

http://www.fda.gov/safesharpsdisposal

FAQs (Frequently asked questions)

Manufactured by:

Galderma Laboratories, L.P.

Dallas, TX 75201

This Instructions for Use has been approved by the U.S. Food and Drug Administration

U.S. License No. 2289

Issued: 06/2025

NEMLUVIO is indicated for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.

Pharmacodynamics of nemolizumab-ilto in the treatment of prurigo nodularis and atopic dermatitis are unknown.

Two randomized, double-blind, placebo-controlled trials (OLYMPIA 1 [NCT04501666] and OLYMPIA 2 [NCT04501679]) enrolled a total of 560 adult subjects with prurigo nodularis (PN). Disease severity was defined using an Investigator’s Global Assessment (IGA) in the overall assessment of prurigo nodularis nodules on a severity scale of 0 to 4. Subjects enrolled in these two trials had an IGA score ≥ 3, severe pruritus as defined by a weekly average of the peak pruritus numeric rating scale (PP-NRS) score of ≥7 on a scale of 0 to 10, and greater than or equal to 20 nodular lesions. OLYMPIA 1 and OLYMPIA 2 assessed the effect of NEMLUVIO on the signs and symptoms of PN, targeting improvement in skin lesions and pruritus over 16 weeks. In OLYMPIA 1, subjects were extended up to 24 weeks of treatment.

Subjects weighing less than 90 kg in the NEMLUVIO group received subcutaneous injections of NEMLUVIO 60 mg at Week 0, followed by NEMLUVIO 30 mg injections every 4 weeks. Subjects weighing 90 kg or more in the NEMLUVIO group received subcutaneous injections of NEMLUVIO 60 mg at Week 0 and every 4 weeks.

In these trials, at baseline, 60% of subjects were female, 81% were White, 9% were Asian, 7% were Black or African American; for ethnicity, 4% of subjects identified as Hispanic or Latino. Twenty-five (25)% of subjects were older than 65 years of age. Thirty-two (32)% of subjects had a history of atopy. The baseline weekly average PP-NRS score was a mean of 8.5. Fifty-eight (58)% of subjects had a baseline IGA score of 3 (moderate PN), and 42% of subjects had a baseline IGA of 4 (severe PN).

The PP-NRS score is a weekly average of daily PP-NRS scores on an 11-point scale from 0-10 that assesses the maximal intensity of pruritus in the last 24 hours with 0 being no itch and 10 being worst itch imaginable. The IGA is a 5-category scale, including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe” indicating the investigator’s overall assessment of the pruriginous nodules.

Efficacy was assessed with the proportion of subjects with an improvement of ≥4 from baseline in PP-NRS, the proportion of subjects with an IGA of 0 (Clear) or 1 (Almost Clear) and a ≥2-point improvement from baseline, the proportion of subjects who achieved a response in both PP-NRS and IGA per the criteria described above, and the proportion of subjects with PP-NRS <2.

The efficacy results for OLYMPIA 1 and OLYMPIA 2 are presented in Table 3 and Figures 1, 2, and 3.

Figure 1:  Proportion of Adult Subjects with PN with PP-NRS Improvement ≥4 from Baseline Over Time  in OLYMPIA 1 and OLYMPIA 2^a

^a Subjects who received rescue therapy or had missing data (fewer than 4 PP-NRS daily diary entries in a 7-day period) were considered non-responders.

Figure 2:  Proportion of Adult Subjects with PN with PP-NRS <2 Over Time in OLYMPIA 1 and OLYMPIA 2^a

^a Subjects who received rescue therapy or had missing data (fewer than 4 PP-NRS daily diary entries in a 7-day period) were considered non-responders.

Figure 3:  Proportion of Adult Subjects with PN with IGA Response^a Over Time in OLYMPIA 1 and OLYMPA 2^b

^a Response was defined as an IGA of 0 (Clear) or 1 (Almost Clear) and a ≥2-point improvement from baseline.

^b Subjects who received rescue therapy or had missing data were considered non-responders.

Examination of weight, age, gender, race, history of atopy, and prior treatment did not identify meaningful differences in response to NEMLUVIO among these subgroups at Week 16.

Two randomized, double-blind, placebo-controlled trials (ARCADIA 1 [NCT03985943] and ARCADIA 2 [NCT03989349]) enrolled a total of 1728 subjects 12 years of age and older with moderate-to-severe atopic dermatitis not adequately controlled by topical treatments. Disease severity was defined by an Investigator’s Global Assessment (IGA) score of 3 (moderate) and 4 (severe) in the overall assessment of atopic dermatitis, an Eczema Area and Severity Index (EASI) score of ≥16, a minimum body surface area (BSA) involvement of ≥10%, and a Peak Pruritus Numeric Rating Scale (PP-NRS) score of ≥ 4.

During the initial 16-week treatment period, subjects in the NEMLUVIO group received an initial subcutaneous injection of NEMLUVIO 60 mg (two 30 mg injections), followed by 30 mg injections every 4 weeks. Concomitant low and/or medium potency TCS and/or TCI were administered for at least 14 days prior to baseline and continued during the trial. Based on disease activity, these concomitant therapies could be tapered and/or discontinued at investigator discretion.

After 16 weeks, subjects achieving either EASI-75 or IGA success (i.e. NEMLUVIO responders) continued into the trial maintenance period for another 32 weeks to evaluate the maintenance of response achieved at Week 16. NEMLUVIO responders were re-randomized to receive either NEMLUVIO 30 mg every 4 weeks, NEMLUVIO 30 mg every 8 weeks, or placebo every 4 weeks (all groups continued background TCS/TCI). Subjects randomized to placebo in the initial treatment period who achieved the same clinical response at Week 16 continued to receive placebo every 4 weeks.

In these trials, at baseline, 51% of subjects were male, 80% were White, 13% were Asian, and 6% were Black or African American; for ethnicity, 9% of subjects identified as Hispanic or Latino. Fifteen (15)% of subjects were 12-17 years of age. Seventy (70)% of subjects had a baseline IGA score of 3 (moderate AD), and 30% of subjects had a baseline IGA score of 4 (severe AD). The baseline mean EASI score was 27.5 and the baseline mean weekly average PP-NRS was 7.1. Overall, 63% of subjects received other previous systemic treatments for AD.

The IGA is a 5-category scale, including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe” indicating the investigator’s overall assessment of the AD. EASI scores range from 0 to 72 points and reflect the severity and extent of AD. EASI-75 indicates at least a 75% improvement in EASI score from baseline. The PP-NRS score is a weekly average of daily PP NRS scores on an 11-point scale from 0-10 that assesses the maximal intensity of pruritus in the last 24 hours with 0 being no itch and 10 being worst itch imaginable.

Both ARCADIA 1 and ARCADIA 2 assessed the co-primary endpoints of:

• Proportion of subjects with an IGA success (defined as an IGA of 0 [clear] or 1 [almost clear] and a ≥2- point reduction from baseline) at Week 16
• Proportion of subjects with EASI-75 (≥75% improvement in EASI from baseline) at Week 16

PP-NRS improvement ≥ 4 from baseline at Week 16 was a key secondary outcome in both trials.

Clinical Response at Week 16 (ARCADIA 1 and ARCADIA 2)

The efficacy results for ARCADIA 1 and ARCADIA 2 evaluating the initial treatment period with NEMLUVIO administered every 4 weeks over 16 weeks are presented in Table 4.

Examination of weight, age, gender, race, and prior treatment did not identify meaningful difference in response to NEMLUVIO among these subgroups at Week 16.

Maintenance and Durability of Response (Week 16 to Week 48)

The maintenance and durability of response in NEMLUVIO responders (IGA 0/1 or EASI-75 at Week 16) was evaluated between Week 16 and Week 48 in ARCADIA 1 and ARCADIA 2 trials. For the maintenance treatment period, NEMLUVIO responders were re-randomized to NEMLUVIO 30 mg every 4 weeks, NEMLUVIO 30 mg every 8 weeks or placebo every 4 weeks (NEMLUVIO withdrawal) with concomitant TCS/TCI. The results are presented in Table 5.

NEMLUVIO is an interleukin-31 receptor antagonist indicated for:

Prurigo Nodularis

The treatment of adults with prurigo nodularis. (1.1)

Atopic Dermatitis

The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. (1.2)

Nemolizumab-ilto is a humanized IgG2 monoclonal antibody that inhibits IL-31 signaling by binding selectively to IL-31 RA. IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis. Nemolizumab-ilto inhibited IL-31-induced responses including the release of proinflammatory cytokines and chemokines.

• Hypersensitivity: Hypersensitivity reactions have been reported with NEMLUVIO use. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO. (5.1)
• Vaccinations: Avoid use of live vaccines during treatment with NEMLUVIO. (5.2)

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. (2.1)

Prurigo Nodularis:

• Adult Patients Weighing Less Than 90kg: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. (2.2)
• Adult Patients Weighing 90kg or More: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks. (2.2)

Atopic Dermatitis:

• The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. (2.3) 
• After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended. (2.3)
• Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies. (2.3)
• Administer NEMLUVIO by subcutaneous injection. (2.5)
• NEMLUVIO must be reconstituted prior to administration. (2.6)

For injection: single-dose, prefilled, dual-chamber pen containing 30 mg of nemolizumab-ilto as a white lyophilized powder in one chamber and diluent, water for injection, in the other chamber.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Hypersensitivity

Advise patients to seek immediate medical attention and discontinue NEMLUVIO if they experience any symptoms of hypersensitivity reactions [see Warnings and Precautions (5.1)].



Vaccinations

Instruct patients to inform their healthcare provider that they are taking NEMLUVIO prior to a potential vaccination [see Warnings and Precautions (5.2)].



Administration Instructions:

• Instruct patients and/or caregivers to receive proper training in subcutaneous injection technique prior to self-injection [see Dosage and Administration (2.5)] . Inform patients and/or caregivers that Galderma Customer Support may be called toll-free for assistance at 1-866-735-4137. 
• Inform patients that NEMLUVIO must be reconstituted prior to administration. Advise patients and/or caregivers to refer to the Instructions for Use that accompanies the NEMLUVIO pen for complete mixing and administration instructions with illustrations [see Dosage and Administration (2.5, 2.6), Instructions for Use]. 
• Inform patients and/or caregivers of proper pen disposal and caution against any reuse of needles. Instruct patients and/or caregivers to discard used pens in an appropriate sharps disposal container following safe needle disposal practices [see Instructions for Use]. 
• Advise patients and/or caregivers of the importance of complying with dosing schedule. If a dose is missed, instruct patients and/or caregivers to administer the injection as soon as possible, and thereafter, resume dosing at the regular scheduled time [see Dosage and Administration (2.4)].

Manufactured by:

Galderma Laboratories, L.P., Dallas, TX 75201

U.S. License No. 2289

NEMLUVIO^® is a registered trademark of Galderma.

© 2025 Galderma Laboratories, L.P. All rights reserved.

• Before injection, remove NEMLUVIO carton from the refrigerator and allow to reach room temperature (30-45 minutes).
• Inspect NEMLUVIO visually prior to reconstitution. NEMLUVIO is supplied in a single-dose, prefilled, dual-chamber pen with white powder in one chamber and a clear diluent in the other chamber. Do not use if powder is not white, or if diluent is cloudy or contains visible particles.
• NEMLUVIO must be reconstituted prior to administration. Refer to the Instructions for Use for complete preparation instructions with illustrations [see Instructions for Use]. 
• Following reconstitution, each prefilled pen delivers 30 mg/0.49 mL as a clear and colorless to slightly yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the reconstituted solution has discoloration or contains particles. 
• Use NEMLUVIO pens within 4 hours after reconstitution. Discard unused reconstituted NEMLUVIO pens after 4 hours. 
• Discard any unused portions after administration.

How Supplied

NEMLUVIO (nemolizumab-ilto) for injection is a sterile, preservative-free, white lyophilized powder available in a single-dose, dual-chamber, prefilled pen containing 30 mg of nemolizumab-ilto in one chamber and the diluent, water for injection, in the other chamber. Following reconstitution, each prefilled pen delivers 30 mg/0.49 mL of nemolizumab-ilto.

Each carton contains 1 single-dose prefilled pen:

Storage and Handling

Store the NEMLUVIO dual-chamber, prefilled pen in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the expiration date. Do not freeze. Do NOT expose to heat or direct sunlight.

Alternatively, the NEMLUVIO carton containing the unused dual-chamber, prefilled pen may be stored at room temperature [up to 77°F (25°C)] for up to 90 days. Write the date the NEMLUVIO dual-chamber, prefilled pen is first removed from the refrigerator in the space provided on the inner partition for the pen. Do not use the NEMLUVIO dual-chamber, prefilled pen beyond the expiration date or 90 days after the date it was first removed from the refrigerator (whichever is earlier).

• NEMLUVIO is administered by subcutaneous injection.
• NEMLUVIO is intended for use under the guidance of a healthcare provider. Prior to the first injection, provide patients and/or caregivers with proper training on the preparation and administration of NEMLUVIO. Patients may self-inject NEMLUVIO after receiving training on subcutaneous injection techniques. In pediatric patients 12 years of age and older, administer NEMLUVIO by or under the supervision of a trained adult or caregiver. 
• For the initial dose, administer each of the two NEMLUVIO injections at different injection sites. 
• Administer NEMLUVIO subcutaneously into the front upper thighs or abdomen avoiding the 2-inch (5 cm) area around the navel. NEMLUVO may be subcutaneously injected into the upper arm, but this should only be performed by a caregiver or healthcare professional. 
• Alternate the injection site with each injection. Do not inject NEMLUVIO into skin that is tender, inflamed, swollen, damaged or has bruises or scars or open wounds. 
• Refer to the Instructions for Use for complete administration instructions with illustrations [see Instructions for Use].

The recommended subcutaneous dosage of NEMLUVIO in adults and pediatric patients 12 years of age and older is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.



After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a subcutaneous dosage of 30 mg every 8 weeks is recommended.



Concomitant Topical Therapies:

Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies.

Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of NEMLUVIO.



No effects on fertility parameters as reproductive organ morphology, menstrual cycle length, or sperm/testicular analysis were observed in male or female sexually mature cynomolgus monkeys that were administered nemolizumab-ilto at subcutaneous doses up to 25 mg/kg once every two weeks for 6 months (53 times the MRHD for PN and 72 times for AD, based on AUC comparison). The monkeys were not mated to evaluate fertility.

IMPORTANT:

CAREFULLY read and follow Instructions for Use.

This pen requires specific steps before injection.



1 Single-Dose Pre-Filled Dual-Chamber Pen



Keep out of reach of children. Do NOT use after expiration. 

Do NOT use if seal is broken or damaged.  Dosage: See Prescribing 



For Subcutaneous Use

MUST BE RECONSTITUTED BEFORE INJECTION

Single-Dose only



GALDERMA



NDC 0299-6220-15      Rx only



nemluvio™

(nemluvio-ilto) for injection 30 mg

Adult Patients Weighing Less Than 90 kg:

The recommended subcutaneous dosage of NEMLUVIO for adult patients weighing less than 90 kg is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.



Adult Patients Weighing 90 kg or More:

The recommended subcutaneous dosage of NEMLUVIO for adult patients weighing 90 kg or more is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks.

PATIENT INFORMATION

NEMLUVIO® [Nem LOO vee oh]

(nemolizumab-ilto)

for injection, for subcutaneous use

What is NEMLUVIO?

NEMLUVIO is a prescription medicine used:

• to treat adults with prurigo nodularis. 
• to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical). NEMLUVIO can be used with certain prescription topical medicines.

It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age.

It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age.

Do not take NEMLUVIO  if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. See the end of this Patient Information leaflet for a complete list of ingredients in NEMLUVIO.

Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you:

• are scheduled to receive any vaccination. You should avoid receiving a live vaccine right before or during treatment with NEMLUVIO.
• are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby. 
• are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take NEMLUVIO?

• See the detailed Instructions for Use that comes with NEMLUVIO for information on how to prepare and inject NEMLUVIO and how to properly store and throw away (dispose of) used NEMLUVIO prefilled pens. 
• Use NEMLUVIO exactly as prescribed by your healthcare provider. 
• Use NEMLUVIO with prescription topical therapies. When your eczema has sufficiently improved, your healthcare provider may discontinue topical therapies. 
• Your healthcare provider will tell you how much NEMLUVIO to inject and how often to inject it. 
• NEMLUVIO comes as a single-dose prefilled pen with a needle guard. 
• NEMLUVIO is given as an injection under the skin (subcutaneous injection). 
• If your healthcare provider decides that you or a caregiver can give the injections of NEMLUVIO, you or your caregiver should receive training on the right way to prepare and inject NEMLUVIO. Do not try to inject NEMLUVIO until you have been shown the right way by your healthcare provider. 
• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time. 
• If you inject too much NEMLUVIO, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. 
• Your healthcare provider may prescribe other medicines to use with NEMLUVIO. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What should I avoid while taking NEMLUVIO?

You should avoid receiving live vaccines while taking NEMLUVIO.

What are the possible side effects of NEMLUVIO?

NEMLUVIO may cause serious side effects, including:

• allergic reactions (hypersensitivity). NEMLUVIO can cause allergic reactions that can sometimes be serious. Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:

The most common side effects of NEMLUVIO in people treated for prurigo nodularis include:

• headache
• skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)

The most common side effects of NEMLUVIO in people treated for atopic dermatitis include:

• headache
• joint pain
• hives (itchy red rash or wheals)
• muscle aches

These are not all of the possible side effects of NEMLUVIO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store NEMLUVIO?

• Store NEMLUVIO in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date. 
• Store NEMLUVIO in the original carton to protect from light. 
• NEMLUVIO can be stored at room temperature up to 77ºF (25ºC) for a single period up to 90 days.
• Throw away (dispose of) NEMLUVIO after the expiration date and any NEMLUVIO that has been left at room temperature for longer than 90 days. 
• After the NEMLUVIO lyophilized powder and water for injection are mixed (reconstituted), NEMLUVIO must be used within 4 hours or thrown away (discarded). 
• Do not heat or put NEMLUVIO pen into direct sunlight. 
• Do not freeze the NEMLUVIO pen. 
• If the NEMLUVIO pen was heated or frozen, throw it away (dispose of it).

Keep NEMLUVIO and all medicines out of the reach of children.

General information about the safe and effective use of NEMLUVIO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NEMLUVIO for a condition for which it was not prescribed. Do not give NEMLUVIO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NEMLUVIO that is written for healthcare professionals.

What are the ingredients in NEMLUVIO?

Active ingredient: nemolizumab-ilto

Inactive ingredients: arginine hydrochloride, poloxamer 188, sucrose, trometamol, and tris hydrochloride.

Manufactured by: Galderma Laboratories, L.P., Dallas, TX 75201

U.S. License No. 2289

NEMLUVIO^® is a registered trademark of Galderma.

© 2025 Galderma Laboratories, L.P. All rights reserved.

For more information, go to www.NEMLUVIO.com or call 1-866-735-4137.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 06/2025

NEMLUVIO is indicated for the treatment of adults with prurigo nodularis.

There is no specific treatment for NEMLUVIO overdosage. In the event of overdosage, contact Poison Control (1-800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

Risk Summary

Available data on NEMLUVIO use in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In an enhanced pre- and postnatal development study in cynomolgus monkeys, when nemolizumab-ilto was administered subcutaneously during organogenesis to parturition, an increase in early postnatal death was observed at a dose 36 times the maximum recommended human dose (MRHD) for PN and 50 times for AD (see Data). The clinical significance of this nonclinical finding is unknown.



The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Risk Summary

There are no data on the presence of nemolizumab-ilto in human milk, the effects on the breastfed infant, or the effects on milk production. Nemolizumab-ilto was detected in breast milk of monkeys (see Data). Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to nemolizumab-ilto are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from the underlying maternal condition.

Nemolizumab-ilto, an interleukin-31 receptor alpha (IL-31RA) antagonist, is a humanized monoclonal modified immunoglobulin G (IgG) antibody with a molecular weight of approximately 144 kDa. Nemolizumab-ilto is produced by recombinant DNA technology in Chinese Hamster Ovary cells.

NEMLUVIO (nemolizumab-ilto) for injection is a sterile, preservative-free, white lyophilized powder in a dualchamber, single-dose, prefilled pen for subcutaneous use. One chamber contains 30 mg of nemolizumab-ilto with inactive ingredients arginine hydrochloride (9.5 mg), poloxamer 188 (0.15 mg), sucrose (25.8 mg), trometamol (0.10 mg), and tris hydrochloride for pH adjustment. The diluent, water for injection, is in the other chamber. Following reconstitution, each prefilled pen delivers 30 mg/0.49 mL of nemolizumab-ilto with a pH of 6.7 to 7.3.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. Avoid use of live vaccines in patients during treatment with NEMLUVIO. It is unknown if administration of live vaccines during NEMLUVIO treatment will impact the safety or effectiveness of these vaccines. No data are available on the response to non-live vaccines.

Prurigo Nodularis

The safety and effectiveness of NEMLUVIO have not been established in pediatric patients.

Atopic Dermatitis

The safety and effectiveness of NEMLUVIO for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors have been established in pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies. Use of NEMLUVIO for this indication is supported by evidence from two randomized, double-blind, placebo-controlled trials [See Adverse Reactions (6.1) and Clinical Studies (14.2)].



The safety and effectiveness of NEMLUVIO have not been established in pediatric patients younger than 12 years of age.

Prurigo Nodularis

Of the 370 subjects with prurigo nodularis exposed to NEMLUVIO in OLYMPIA 1 and OLYMPIA 2, 99 (26.8%) subjects were 65 years of age or older. The long-term safety of NEMLUVIO was assessed in 508 subjects, among which 133 (26.2%) were 65 years of age or older. Clinical trials of NEMLUVIO did not include sufficient numbers of subjects 65 years of age or older to determine whether they respond differently than younger adult subjects. [see Clinical Pharmacology (12.3)].

Atopic Dermatitis

Of the 1192 subjects with atopic dermatitis exposed to NEMLUVIO in the primary safety population, 72 (6.0%) subjects were 65 years of age or older. The long-term safety of NEMLUVIO was assessed in 78 (4.5%) subjects 65 years of age or older. Clinical studies of NEMLUVIO did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects [see Clinical Pharmacology (12.3)].

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of nemolizumab-ilto or other nemolizumab products.

Prurigo Nodularis:

• In the Phase 3 trials (OLYMPIA 1, OLYMPIA 2) up to 24 weeks, the incidence of treatment-emergent ADAs was 7%; neutralizing antibodies were seen in 3% of subjects.

Atopic Dermatitis:

• In the phase 3 trials (ARCADIA 1, ARCADIA 2) up to 16 weeks, the incidence of treatment-emergent ADAs was 6.1% (67/1092). Among subjects who continued treatment from week 16 through week 48 in the two studies, the ADA incidence was 13.9% (23/166) for those that received 30 mg every 4 weeks, and 10.6% (17/161) for those that received 30 mg every 8 weeks. Neutralizing antibody incidence was 4.5% (3/67) among the ADA+ subjects throughout 48 weeks in ARCADIA 1 and ARCADIA 2, respectively.

Anti-Drug Antibody Effects on Pharmacokinetics and Pharmacodynamics

• Prurigo Nodularis: In the phase 3 trials in subjects with prurigo nodularis, there was no identified clinically significant effect of anti-drug antibodies on the pharmacokinetics, safety or efficacy of nemolizumab-ilto over the treatment duration of 24 weeks. 
  
  
  
  
• Atopic Dermatitis: In the phase 3 trials in subjects with atopic dermatitis, antibodies to nemolizumab-ilto were associated with reduced serum nemolizumab-ilto concentrations beyond Week 16. NEMLUVIO treated subjects who developed ADAs had nemolizumab-ilto concentrations that were 20% to 70% lower compared to subjects who did not develop ADAs. There was no clinically significant effect of anti-drug antibodies on safety or efficacy of nemolizumab-ilto over the treatment duration of 48 weeks.

NEMLUVIO is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO [see Warnings and Precautions (5.1)].

The following clinically significant adverse reactions are described in greater details elsewhere in the labeling:

• Hypersensitivity [see Warnings and Precautions (5.1)]

Hypersensitivity reactions, such as facial angioedema, have been reported with use of NEMLUVIO. NEMLUVIO is contraindicated in patients with a known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO [see Contraindications (4), Adverse Reactions (6.1)].

NEMLUVIO® [Nem LOO vee oh]

(nemolizumab-ilto)

for injection, for subcutaneous use 

This Instructions for Use contains information on how to inject NEMLUVIO.



Read and understand these instructions before using the NEMLUVIO pen.



Do not inject yourself or someone else until you have been instructed how to inject NEMLUVIO.



In adolescents (ages 12 to 17 years old), it is recommended that NEMLUVIO be given by or under supervision of a trained adult or caregiver.



Your healthcare provider will instruct you or your caregiver how to prepare and inject a dose of NEMLUVIO before you try to do it yourself the first time. Call your healthcare provider if you have any questions.



NEMLUVIO is supplied as a single-dose pen (called NEMLUVIO pen or pen in these instructions). It contains medicine (30 mg of lyophilized powder) in one chamber and water for dissolving the medicine in the other chamber. Before you can inject it, you must mix the lyophilized powder with the water for dissolving the medicine.

Important Information



What you need to know before using the NEMLUVIO pen:

• Read all the instructions carefully before using the NEMLUVIO pen.
• Mark your calendar ahead of time to remember when to take NEMLUVIO. 
• Do not use the NEMLUVIO pen if it has been dropped on a hard surface or is damaged, cracked or broken. 
• Follow all steps exactly as described. This makes sure that you get the correct dose of medicine. 
• Make sure that the lyophilized powder is completely dissolved before injecting (Step 9). After dissolving the powder, inject the medicine right away to avoid any contamination or break down of medicine (degradation). 
• To use the pen for injection, while holding upright, gently twist (do not pull) the gray cap to the left (counterclockwise) until the orange needle guard pops up. Then, gently pull the gray cap off the orange needle guard. Do not press the orange needle guard until ready to inject (Step 12). 
• In some cases, your healthcare provider may prescribe 2 pens for a full dose. Use the second NEMLUVIO pen right away after using the first pen. Choose a different injection site at least 1 inch away from the first injection site. 
• To reduce the risk of accidental needle stick injury, each NEMLUVIO pen has an orange needle guard. After injecting the medicine and lifting the pen from your skin, the orange needle guard locks into place automatically to cover the needle (Step 16).
• Throw away (dispose of) the used NEMLUVIO pen right away after use in a sharps disposal container. See Section C: Throwing away (Disposing of) NEMLUVIO below.
  
  

Storage Information:

• Store the NEMLUVIO pen in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date. 
• Store the NEMLUVIO pen in the original carton to protect it from light. 
• The NEMLUVIO pen can be stored at room temperature up to 77°F (25°C) for up to 90 days.
• Throw away (dispose of) the NEMLUVIO pen after the expiration date and any NEMLUVIO pen that has been left at room temperature longer than 90 days. 
• After the NEMLUVIO pen lyophilized powder and water for injection are mixed (reconstituted), the NEMLUVIO pen must be used within 4 hours or thrown away (disposed of). 
• Do not heat or put the NEMLUVIO pen into direct sunlight. 
• Do not freeze the NEMLUVIO pen. 
• If the NEMLUVIO pen was heated or frozen, throw it away (dispose of it).

Keep the NEMLUVIO pen and all medicines out of the reach of children.

Traveling Information:

• Generally, you are allowed to carry pens with you on an airplane. Be sure to carry the NEMLUVIO pens in the original carton with you in your carry-on luggage.
  
  
  
  If you have any other questions refer to the Frequently asked questions (FAQs) on the back of this leaflet.

A. Preparing to inject NEMLUVIO

Step 1: Let NEMLUVIO reach room temperature

Injecting cold medicine might result in pain at the injection site.

Take the NEMLUVIO carton out of the refrigerator and let it come to room temperature for 30 to 45 minutes before starting Step 2 (see Figure A).

Do not:

• warm the pen with any heat source (such as microwave or direct sunlight).  This might damage NEMLUVIO.
• directly expose the pen to liquids.

Step 2: Wash your hands

a. Wash your hands with soap and water to avoid contamination and infection (see Figure B).

b. Dry hands completely.

Step 3: Gather Supplies (see Figure C)

a. Remove the pen from the carton.

b. Gather the following supplies on a clean, flat and well-lit surface:

• Pen
• Alcohol wipes*
• Sharps disposal container*
• Gauze pads or cotton balls*

*Items not included in the carton.



Note: In some cases, your healthcare provider may prescribe 2 pens. Use 1 pen after the other.

Step 4: Check the NEMLUVIO pen for the following:

a. Expiration date has not passed.

b. The lyophilized powder is white and not dissolved (see Figure D).

c. The pen has not been dropped and is not damaged or cracked.

Step 5: Activate the NEMLUVIO pen

Hold the pen upright and unlock the pen by turning the activation knob to the right until it stops (see Figure E).



This starts the process of transferring water to the powder chamber.



Only turn the activation knob to the right once.

Step 6: Wait until the gray rod stops moving

Watch inspection window until gray rod has stopped moving (see Figure F).

Step 7: Dissolve the medicine

When the gray rod has completely stopped, hold the pen upright and shake the pen up and down for 30 seconds (see Figure G).

Step 8: Wait 5 minutes for bubbles to decrease

Wait for bubbles to decrease and the lyophilized powder to dissolve completely. This will take about 5 minutes (see Figure H).

Step 9: Check the medicine in the inspection window

Check to see if the dissolved medicine:

• is clear and colorless to slightly yellow,
• does not contain particles (see Figure I).
  
  
  
  
  

Do not use the pen if the dissolved medicine is cloudy or contains any particles.



Throw away (dispose of) the pen and use a new one (see Section C: Throwing away (Disposing of) NEMLUVIO).



Note: After the medicine has dissolved, it must be used within 4 hours. During this time, it should be kept at room temperature (up to 77°F (25°C)). If you have not used it within 4 hours, throw it away (dispose of it).

B. Injecting NEMLUVIO

Step 10: Select one injection site (see Figure J)



Note: When using a second pen, select a different injection site at least 1 inch away from the first injection site.



Select the injection site using the following chart:

Where not to inject:

• near your waistline within about 2 inches around the navel. 
• into tender, bruised, red skin, or areas with scars or stretch marks. 
• twice into the same site (for example, within 1 inch).

Step 11: Clean the injection site (see Figure K)



a.  Always use a new alcohol wipe to clean the injection site to avoid contamination and infection.

b. Let the skin air dry.

Do not:

• touch the injection site after cleaning.
• fan, or blow air on the cleaned injection site.
• reuse the alcohol wipe.

Step 12: Twist the gray cap



Do not:

• pull the gray cap when twisting to avoid damaging the device.
• touch the orange needle guard.

• Hold the pen upright (see Figure L, a)
• Gently twist the gray cap to the left (counterclockwise) until the orange needle guard pops up (see Figure L, b).
• Gently pull the gray cap off the orange needle guard (see Figure L, c). Do not press on the orange needle guard until ready to inject.
• After cap removal, please throw away (dispose of) the cap in a sharps disposal container (see Step 17).

Note: If the cap cannot be removed, refer back to Step 5 and make sure the activation knob is turned completely to the right until it stops.

Step 13: Place the NEMLUVIO pen

Read Steps 13-16 before starting Step 13.

Note: Always inject the way your healthcare provider showed you.



Place the pen on the injection site vertically so that the orange needle guard is flat against the skin (see Figure M).



Note: Make sure you can easily see the inspection window during injection.

Step 14: Start injection and hold the NEMLUVIO pen on the skin



Gently push the pen down until the orange needle guard is completely pushed in.



The injection starts right away with a click (see Figure N).



The orange rod will begin to move down the injection window.



Do not lift the pen yet and keep pushing down.

Step 15: Inject for 15 seconds



Hold the pen in position and slowly count to 15 or use a timer or clock to count 15 seconds.



Check the inspection window to make sure the orange rod and gray rod have stopped moving (see Figure O).



This means the injection has been completed.



Note: It is normal that the orange rod does not cover the whole inspection window at the end of injection.

Step 16: Lift the NEMLUVIO pen up

a. Lift the pen straight up from your skin.

The orange needle guard automatically locks into place to cover the needle (see Figure P).

    

b. If there is bleeding, press a cotton ball or gauze over the injection site.

C. Throwing away (disposing of) NEMLUVIO

Step 17: Throw away (dispose of) NEMLUVIO in a sharps disposal container



Avoid contact with the needle.



Throw away (dispose of) the used pen and the gray cap in an FDA cleared sharps disposal container right away after use (see Figure Q).

• recap the pen after use,
• dispose of the NEMLUVIO pen and cap in your household trash,
• dispose of your used sharps disposal container in your household trash unless your community guidelines permit this,
• recycle your used sharps disposal container.

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, 
• upright and stable during use,
• leak-resistant and 
• properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.

There may be state or local laws about how you should dispose of used pens.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:

http://www.fda.gov/safesharpsdisposal

FAQs (Frequently asked questions)

Manufactured by:

Galderma Laboratories, L.P.

Dallas, TX 75201

This Instructions for Use has been approved by the U.S. Food and Drug Administration

U.S. License No. 2289

Issued: 06/2025

NEMLUVIO is indicated for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.

Pharmacodynamics of nemolizumab-ilto in the treatment of prurigo nodularis and atopic dermatitis are unknown.

Two randomized, double-blind, placebo-controlled trials (OLYMPIA 1 [NCT04501666] and OLYMPIA 2 [NCT04501679]) enrolled a total of 560 adult subjects with prurigo nodularis (PN). Disease severity was defined using an Investigator’s Global Assessment (IGA) in the overall assessment of prurigo nodularis nodules on a severity scale of 0 to 4. Subjects enrolled in these two trials had an IGA score ≥ 3, severe pruritus as defined by a weekly average of the peak pruritus numeric rating scale (PP-NRS) score of ≥7 on a scale of 0 to 10, and greater than or equal to 20 nodular lesions. OLYMPIA 1 and OLYMPIA 2 assessed the effect of NEMLUVIO on the signs and symptoms of PN, targeting improvement in skin lesions and pruritus over 16 weeks. In OLYMPIA 1, subjects were extended up to 24 weeks of treatment.

Subjects weighing less than 90 kg in the NEMLUVIO group received subcutaneous injections of NEMLUVIO 60 mg at Week 0, followed by NEMLUVIO 30 mg injections every 4 weeks. Subjects weighing 90 kg or more in the NEMLUVIO group received subcutaneous injections of NEMLUVIO 60 mg at Week 0 and every 4 weeks.

In these trials, at baseline, 60% of subjects were female, 81% were White, 9% were Asian, 7% were Black or African American; for ethnicity, 4% of subjects identified as Hispanic or Latino. Twenty-five (25)% of subjects were older than 65 years of age. Thirty-two (32)% of subjects had a history of atopy. The baseline weekly average PP-NRS score was a mean of 8.5. Fifty-eight (58)% of subjects had a baseline IGA score of 3 (moderate PN), and 42% of subjects had a baseline IGA of 4 (severe PN).

The PP-NRS score is a weekly average of daily PP-NRS scores on an 11-point scale from 0-10 that assesses the maximal intensity of pruritus in the last 24 hours with 0 being no itch and 10 being worst itch imaginable. The IGA is a 5-category scale, including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe” indicating the investigator’s overall assessment of the pruriginous nodules.

Efficacy was assessed with the proportion of subjects with an improvement of ≥4 from baseline in PP-NRS, the proportion of subjects with an IGA of 0 (Clear) or 1 (Almost Clear) and a ≥2-point improvement from baseline, the proportion of subjects who achieved a response in both PP-NRS and IGA per the criteria described above, and the proportion of subjects with PP-NRS <2.

The efficacy results for OLYMPIA 1 and OLYMPIA 2 are presented in Table 3 and Figures 1, 2, and 3.

Figure 1:  Proportion of Adult Subjects with PN with PP-NRS Improvement ≥4 from Baseline Over Time  in OLYMPIA 1 and OLYMPIA 2^a

^a Subjects who received rescue therapy or had missing data (fewer than 4 PP-NRS daily diary entries in a 7-day period) were considered non-responders.

Figure 2:  Proportion of Adult Subjects with PN with PP-NRS <2 Over Time in OLYMPIA 1 and OLYMPIA 2^a

^a Subjects who received rescue therapy or had missing data (fewer than 4 PP-NRS daily diary entries in a 7-day period) were considered non-responders.

Figure 3:  Proportion of Adult Subjects with PN with IGA Response^a Over Time in OLYMPIA 1 and OLYMPA 2^b

^a Response was defined as an IGA of 0 (Clear) or 1 (Almost Clear) and a ≥2-point improvement from baseline.

^b Subjects who received rescue therapy or had missing data were considered non-responders.

Examination of weight, age, gender, race, history of atopy, and prior treatment did not identify meaningful differences in response to NEMLUVIO among these subgroups at Week 16.

Two randomized, double-blind, placebo-controlled trials (ARCADIA 1 [NCT03985943] and ARCADIA 2 [NCT03989349]) enrolled a total of 1728 subjects 12 years of age and older with moderate-to-severe atopic dermatitis not adequately controlled by topical treatments. Disease severity was defined by an Investigator’s Global Assessment (IGA) score of 3 (moderate) and 4 (severe) in the overall assessment of atopic dermatitis, an Eczema Area and Severity Index (EASI) score of ≥16, a minimum body surface area (BSA) involvement of ≥10%, and a Peak Pruritus Numeric Rating Scale (PP-NRS) score of ≥ 4.

During the initial 16-week treatment period, subjects in the NEMLUVIO group received an initial subcutaneous injection of NEMLUVIO 60 mg (two 30 mg injections), followed by 30 mg injections every 4 weeks. Concomitant low and/or medium potency TCS and/or TCI were administered for at least 14 days prior to baseline and continued during the trial. Based on disease activity, these concomitant therapies could be tapered and/or discontinued at investigator discretion.

After 16 weeks, subjects achieving either EASI-75 or IGA success (i.e. NEMLUVIO responders) continued into the trial maintenance period for another 32 weeks to evaluate the maintenance of response achieved at Week 16. NEMLUVIO responders were re-randomized to receive either NEMLUVIO 30 mg every 4 weeks, NEMLUVIO 30 mg every 8 weeks, or placebo every 4 weeks (all groups continued background TCS/TCI). Subjects randomized to placebo in the initial treatment period who achieved the same clinical response at Week 16 continued to receive placebo every 4 weeks.

In these trials, at baseline, 51% of subjects were male, 80% were White, 13% were Asian, and 6% were Black or African American; for ethnicity, 9% of subjects identified as Hispanic or Latino. Fifteen (15)% of subjects were 12-17 years of age. Seventy (70)% of subjects had a baseline IGA score of 3 (moderate AD), and 30% of subjects had a baseline IGA score of 4 (severe AD). The baseline mean EASI score was 27.5 and the baseline mean weekly average PP-NRS was 7.1. Overall, 63% of subjects received other previous systemic treatments for AD.

The IGA is a 5-category scale, including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe” indicating the investigator’s overall assessment of the AD. EASI scores range from 0 to 72 points and reflect the severity and extent of AD. EASI-75 indicates at least a 75% improvement in EASI score from baseline. The PP-NRS score is a weekly average of daily PP NRS scores on an 11-point scale from 0-10 that assesses the maximal intensity of pruritus in the last 24 hours with 0 being no itch and 10 being worst itch imaginable.

Both ARCADIA 1 and ARCADIA 2 assessed the co-primary endpoints of:

• Proportion of subjects with an IGA success (defined as an IGA of 0 [clear] or 1 [almost clear] and a ≥2- point reduction from baseline) at Week 16
• Proportion of subjects with EASI-75 (≥75% improvement in EASI from baseline) at Week 16

PP-NRS improvement ≥ 4 from baseline at Week 16 was a key secondary outcome in both trials.

Clinical Response at Week 16 (ARCADIA 1 and ARCADIA 2)

The efficacy results for ARCADIA 1 and ARCADIA 2 evaluating the initial treatment period with NEMLUVIO administered every 4 weeks over 16 weeks are presented in Table 4.

Examination of weight, age, gender, race, and prior treatment did not identify meaningful difference in response to NEMLUVIO among these subgroups at Week 16.

Maintenance and Durability of Response (Week 16 to Week 48)

The maintenance and durability of response in NEMLUVIO responders (IGA 0/1 or EASI-75 at Week 16) was evaluated between Week 16 and Week 48 in ARCADIA 1 and ARCADIA 2 trials. For the maintenance treatment period, NEMLUVIO responders were re-randomized to NEMLUVIO 30 mg every 4 weeks, NEMLUVIO 30 mg every 8 weeks or placebo every 4 weeks (NEMLUVIO withdrawal) with concomitant TCS/TCI. The results are presented in Table 5.

NEMLUVIO is an interleukin-31 receptor antagonist indicated for:

Prurigo Nodularis

The treatment of adults with prurigo nodularis. (1.1)

Atopic Dermatitis

The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. (1.2)

Nemolizumab-ilto is a humanized IgG2 monoclonal antibody that inhibits IL-31 signaling by binding selectively to IL-31 RA. IL-31 is a naturally occurring cytokine that is involved in pruritus, inflammation, epidermal dysregulation, and fibrosis. Nemolizumab-ilto inhibited IL-31-induced responses including the release of proinflammatory cytokines and chemokines.

• Hypersensitivity: Hypersensitivity reactions have been reported with NEMLUVIO use. If a clinically significant hypersensitivity reaction occurs, immediately institute appropriate therapy and discontinue NEMLUVIO. (5.1)
• Vaccinations: Avoid use of live vaccines during treatment with NEMLUVIO. (5.2)

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. (2.1)

Prurigo Nodularis:

• Adult Patients Weighing Less Than 90kg: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. (2.2)
• Adult Patients Weighing 90kg or More: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks. (2.2)

Atopic Dermatitis:

• The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. (2.3) 
• After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended. (2.3)
• Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies. (2.3)
• Administer NEMLUVIO by subcutaneous injection. (2.5)
• NEMLUVIO must be reconstituted prior to administration. (2.6)

For injection: single-dose, prefilled, dual-chamber pen containing 30 mg of nemolizumab-ilto as a white lyophilized powder in one chamber and diluent, water for injection, in the other chamber.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Hypersensitivity

Advise patients to seek immediate medical attention and discontinue NEMLUVIO if they experience any symptoms of hypersensitivity reactions [see Warnings and Precautions (5.1)].



Vaccinations

Instruct patients to inform their healthcare provider that they are taking NEMLUVIO prior to a potential vaccination [see Warnings and Precautions (5.2)].



Administration Instructions:

• Instruct patients and/or caregivers to receive proper training in subcutaneous injection technique prior to self-injection [see Dosage and Administration (2.5)] . Inform patients and/or caregivers that Galderma Customer Support may be called toll-free for assistance at 1-866-735-4137. 
• Inform patients that NEMLUVIO must be reconstituted prior to administration. Advise patients and/or caregivers to refer to the Instructions for Use that accompanies the NEMLUVIO pen for complete mixing and administration instructions with illustrations [see Dosage and Administration (2.5, 2.6), Instructions for Use]. 
• Inform patients and/or caregivers of proper pen disposal and caution against any reuse of needles. Instruct patients and/or caregivers to discard used pens in an appropriate sharps disposal container following safe needle disposal practices [see Instructions for Use]. 
• Advise patients and/or caregivers of the importance of complying with dosing schedule. If a dose is missed, instruct patients and/or caregivers to administer the injection as soon as possible, and thereafter, resume dosing at the regular scheduled time [see Dosage and Administration (2.4)].

Manufactured by:

Galderma Laboratories, L.P., Dallas, TX 75201

U.S. License No. 2289

NEMLUVIO^® is a registered trademark of Galderma.

© 2025 Galderma Laboratories, L.P. All rights reserved.

• Before injection, remove NEMLUVIO carton from the refrigerator and allow to reach room temperature (30-45 minutes).
• Inspect NEMLUVIO visually prior to reconstitution. NEMLUVIO is supplied in a single-dose, prefilled, dual-chamber pen with white powder in one chamber and a clear diluent in the other chamber. Do not use if powder is not white, or if diluent is cloudy or contains visible particles.
• NEMLUVIO must be reconstituted prior to administration. Refer to the Instructions for Use for complete preparation instructions with illustrations [see Instructions for Use]. 
• Following reconstitution, each prefilled pen delivers 30 mg/0.49 mL as a clear and colorless to slightly yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the reconstituted solution has discoloration or contains particles. 
• Use NEMLUVIO pens within 4 hours after reconstitution. Discard unused reconstituted NEMLUVIO pens after 4 hours. 
• Discard any unused portions after administration.

How Supplied

NEMLUVIO (nemolizumab-ilto) for injection is a sterile, preservative-free, white lyophilized powder available in a single-dose, dual-chamber, prefilled pen containing 30 mg of nemolizumab-ilto in one chamber and the diluent, water for injection, in the other chamber. Following reconstitution, each prefilled pen delivers 30 mg/0.49 mL of nemolizumab-ilto.

Each carton contains 1 single-dose prefilled pen:

Storage and Handling

Store the NEMLUVIO dual-chamber, prefilled pen in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the expiration date. Do not freeze. Do NOT expose to heat or direct sunlight.

Alternatively, the NEMLUVIO carton containing the unused dual-chamber, prefilled pen may be stored at room temperature [up to 77°F (25°C)] for up to 90 days. Write the date the NEMLUVIO dual-chamber, prefilled pen is first removed from the refrigerator in the space provided on the inner partition for the pen. Do not use the NEMLUVIO dual-chamber, prefilled pen beyond the expiration date or 90 days after the date it was first removed from the refrigerator (whichever is earlier).

• NEMLUVIO is administered by subcutaneous injection.
• NEMLUVIO is intended for use under the guidance of a healthcare provider. Prior to the first injection, provide patients and/or caregivers with proper training on the preparation and administration of NEMLUVIO. Patients may self-inject NEMLUVIO after receiving training on subcutaneous injection techniques. In pediatric patients 12 years of age and older, administer NEMLUVIO by or under the supervision of a trained adult or caregiver. 
• For the initial dose, administer each of the two NEMLUVIO injections at different injection sites. 
• Administer NEMLUVIO subcutaneously into the front upper thighs or abdomen avoiding the 2-inch (5 cm) area around the navel. NEMLUVO may be subcutaneously injected into the upper arm, but this should only be performed by a caregiver or healthcare professional. 
• Alternate the injection site with each injection. Do not inject NEMLUVIO into skin that is tender, inflamed, swollen, damaged or has bruises or scars or open wounds. 
• Refer to the Instructions for Use for complete administration instructions with illustrations [see Instructions for Use].

The recommended subcutaneous dosage of NEMLUVIO in adults and pediatric patients 12 years of age and older is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.



After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a subcutaneous dosage of 30 mg every 8 weeks is recommended.



Concomitant Topical Therapies:

Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies.

Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of NEMLUVIO.



No effects on fertility parameters as reproductive organ morphology, menstrual cycle length, or sperm/testicular analysis were observed in male or female sexually mature cynomolgus monkeys that were administered nemolizumab-ilto at subcutaneous doses up to 25 mg/kg once every two weeks for 6 months (53 times the MRHD for PN and 72 times for AD, based on AUC comparison). The monkeys were not mated to evaluate fertility.

IMPORTANT:

CAREFULLY read and follow Instructions for Use.

This pen requires specific steps before injection.



1 Single-Dose Pre-Filled Dual-Chamber Pen



Keep out of reach of children. Do NOT use after expiration. 

Do NOT use if seal is broken or damaged.  Dosage: See Prescribing 



For Subcutaneous Use

MUST BE RECONSTITUTED BEFORE INJECTION

Single-Dose only



GALDERMA



NDC 0299-6220-15      Rx only



nemluvio™

(nemluvio-ilto) for injection 30 mg