HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NEMLUVIO safely and effectively. See full prescribing
information for NEMLUVIO.
NEMLUVIO® (nemolizumab-ilto) for injection, for subcutaneoususe
Initial U.S. Approval: 2024----------------------INDICATIONS AND USAGE----------------------NEMLUVIO is an interleukin-31 receptor antagonist indicated forthe treatment of adults with prurigo nodularis. (1)------------------DOSAGE AND ADMINISTRATION-----------------• Complete all age-appropriate vaccinations as recommended bycurrent immunization guidelines prior to treatment with
NEMLUVIO, (2.1)• Adult Patients Weighing Less Than 90kg: The recommended
dosage is an initial dose of 60 mg (two 30 mg injections), followed
by 30 mg given every 4 weeks (Q4W). (2.2)• Adult Patients Weighing 90kg or More: The recommended dosage
is an initial dose of 60 mg (two 30 mg injections), followed by 60
mg given every 4 weeks (Q4W). (2.2)• Administer NEMLUVIO by subcutaneous injection. (2.4)• NEMLUVIO must be reconstituted prior to administration. (2.5)----------------DOSAGE FORMS AND STRENGTHS----------------For injection: single-dose prefilled dual chamber pen containing
30 mg of nemolizumab-ilto lyophilized powder and diluent, water
for injection. (3).
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Vaccination Prior to Treatment
2.2 Recommended Dosage
2.3 Missed Dose
2.4 Important Administration Instructions
2.5 Preparation for Use of NEMLUVIO
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
5.2 Vaccinations
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use-------------------------CONTRAINDICATIONS------------------------Known hypersensitivity to nemolizumab-ilto or to any ofthe excipients in NEMLUVIO. (4)------------------WARNINGS AND PRECAUTIONS------------------• Hypersensitivity: Hypersensitivity reactions have been reportedwith NEMLUVIO use. If a clinically significant hypersensitivity
reaction occurs, immediately institute appropriate therapy anddiscontinue NEMLUVIO. (5.1)• Vaccinations: Avoid use of live vaccines during treatment with
NEMLUVIO. (5.2)-------------------------ADVERSE REACTIONS-------------------------Most common adverse reactions (incidence ≥1%) are headache,dermatitis atopic, eczema, and eczema nummular. (6.1)-------------------------DRUG INTERACTIONS-------------------------Cytochrome P450 (CYP450) Substrates: Upon initiation or
discontinuation of NEMLUVIO, consider monitoring for effect (e.g.,
for warfarin) or drug concentration (e.g., for cyclosporine) andconsider dosage modification of the CYP450 substrate.
To report SUSPECTED ADVERSE REACTIONS, contact
Galderma Laboratories, L.P at 1-866-735-4137 or FDA at 1-800FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and
FDA-approved patient labeling.
Revised: 08/2024

10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.6 Immunogenicity
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION* Sections or subsections omitted from the full prescribing
information are not listed

FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
NEMLUVIO is indicated for the treatment of adults with prurigo nodularis.

2 DOSAGE AND ADMINISTRATION
2.1 Vaccination Prior to Treatment
Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior totreatment with NEMLUVIO [see Warnings and Precautions (5.2)].

2.2 Recommended Dosage
Adult Patients Weighing Less Than 90 kg: The recommended subcutaneous dosage of NEMLUVIO for adultpatients weighing less than 90 kg is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given
every 4 weeks (Q4W).
Adult Patients Weighing 90 kg or More: The recommended subcutaneous dosage of NEMLUVIO for adultpatients weighing 90 kg or more is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given
every 4 weeks (Q4W).

2.3 Missed DoseIf a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduledtime.

2.4 Important Administration Instructions•

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.

•

For the initial dose, administer each of the two NEMLUVIO injections at different injection sites.

•

Administer subcutaneous injection into the front upper thighs or abdomen except for the 2 inches (5 cm)
around the navel. Injection in upper arm 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].
2

2.5 Preparation for Use of NEMLUVIO•

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.

•

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 anddiscoloration 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.

•

Refer to the Instructions for Use for complete preparation instructions with illustrations [see Instructions for
Use].

3 DOSAGE FORMS AND STRENGTHS
For injection: single-dose prefilled dual-chamber pen containing 30 mg of nemolizumab-ilto as a whitelyophilized powder in one chamber and diluent, water for injection, in the other chamber.

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

5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
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 theexcipients in NEMLUVIO. If a clinically significant hypersensitivity reaction occurs, immediately instituteappropriate therapy and discontinue NEMLUVIO [see Contraindications (4), Adverse Reactions (6.1)].

5.2 Vaccinations
Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior totreatment with NEMLUVIO. Avoid use of live vaccines in patients during treatment with NEMLUVIO. It is3unknown if administration of live vaccines during NEMLUVIO treatment will impact the safety oreffectiveness of these vaccines. No data are available on the response to non-live vaccines.

6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described in greater details elsewhere in the labeling:
Hypersensitivity [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may notreflect the rates observed in practice.
A total of 508 adult subjects with prurigo nodularis were treated with NEMLUVIO in two placebo-controlled
trials and an open label long-term extension trial. Of these, 375 subjects were exposed for at least 1 year in thedevelopment program for prurigo nodularis.
Two randomized, double-blind, placebo-controlled, multicenter trials (OLYMPIA 1 and OLYMPIA 2)
evaluated the safety of NEMLUVIO in adult subjects with prurigo nodularis. Subjects were treated for up to 24
weeks in OLYMPIA 1 and up to 16 weeks in OLYMPIA 2. In these 2 trials, 370 subjects were treated with
subcutaneous injections of NEMLUVIO, and 186 subjects received placebo injections [see Clinical Studies(14)].
Subjects weighing less than 90 kg in the NEMLUVIO group received NEMLUVIO 60 mg or placebo at Week0, followed by 30 mg injections every 4 weeks. Subjects weighing 90 kg or more in the NEMLUVIO group
received NEMLUVIO 60 mg or placebo at Week 0 and every 4 weeks.
During the treatment period in NEMLUVIO trials (OLYMPIA 1 and OLYMPIA 2), the proportion of subjects
who discontinued treatment because of adverse reactions was 4% in the NEMLUVIO group versus 3% in theplacebo group. Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% in the
NEMLUVIO group, and for which the rate exceeds the rate in the placebo group through Week 16.
Table 1: Adverse Reactions Occurring in ≥1% of Adult Subjects with Prurigo Nodularis in the
NEMLUVIO Group and Greater than Placebo in the OLYMPIA 1 and OLYMPIA 2 Trials
through Week 16.
Adverse Reaction

NEMLUVIO
N= 370n (%)

Placebo(N= 186)n (%)

23 (6%)
16 (4%)
14 (4%)
11 (3%)

6 (3%)
1 (0.5%)3 (2%)
0

Headache*
Dermatitis atopic
EczemaEczema nummular*includes: headache and tension headache

4Specific Adverse Reactions
Hypersensitivity reactions
Type 1 hypersensitivity reactions (Ig-E mediated reactions), including one report of discrete facial (peri-ocular)
angioedema, were reported in subjects treated with NEMLUVIO [see Contraindications (4)].

7

DRUG INTERACTIONS

Cytochrome P450 Substrates
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL10, TNFα, IFN) during chronic inflammation. Treatment with NEMLUVIO may modulate serum levels of somecytokines and influence the formation of CYP450 enzymes.
Therefore, upon initiation or discontinuation of NEMLUVIO in patients who are receiving concomitant drugs
which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect(e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the
CYP450 substrate.

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
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.
Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during thethird trimester; therefore, NEMLUVIO may be transferred from the mother to the developing fetus (see Clinical
Considerations). In an enhanced pre- and postnatal development study in cynomolgus monkeys, whennemolizumab-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) (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 recognizedpregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Fetal/Neonatal Adverse Reactions
Because nemolizumab-ilto may interfere with immune response to infections, risks and benefits should beconsidered prior to administering live vaccines to infants exposed to NEMLUVIO in utero. There are no data
regarding infant serum levels of nemolizumab-ilto at birth and the duration of persistence of nemolizumab-ilto
in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed
in utero is unknown, a minimum of 3 months after birth should be considered because of the half-life of the
product.

5

Data
Animal Data
In an enhanced pre- and postnatal development study, subcutaneous doses up to 25 mg/kg nemolizumab-iltowere administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to parturition.
No maternal or embryofetal toxicities were observed at doses up to 25 mg/kg (36 times the MRHD, based on
AUC comparison). Early postnatal death occurred in the offspring of one control monkey and 3 monkeys at 25
mg/kg (36 times the MRHD, based on AUC comparison). The clinical significance of this nonclinical finding is
unknown. Nemolizumab-ilto was administered subcutaneously to the offspring at doses up to 25 mg/kg (122times the MRHD, based on AUC comparison), once every 2 weeks for 6 months, starting from postnatal day 35.
No adverse effects were noted in the remaining offspring.

8.2 Lactation
Risk Summary
There are no data on the presence of nemolizumab-ilto in human milk, the effects on the breastfed infant, or theeffects 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 needfor NEMLUVIO and any potential adverse effects on the breastfed child from NEMLUVIO or from theunderlying maternal condition.
Data
Nemolizumab-ilto was detected in breast milk of monkeys in the enhanced pre- and postnatal development
study following subcutaneous doses up to 25 mg/kg once every two weeks during organogenesis to parturition.
The mean nemolizumab-ilto concentrations in milk were approximately 0.3 – 0.5% of the maternal plasma
levels from lactation day 7 to 63. The concentration of nemolizumab-ilto in animal milk does not necessarily
predict the concentration of drug in human milk.

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

8.5 Geriatric Use
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 notinclude sufficient number of subjects 65 years of age or older to determine whether they respond differently
than younger adult subjects. [see Clinical Pharmacology (12.3)].

10 OVERDOSAGE
There is no specific treatment for NEMLUVIO overdose. In the event of overdosage, contact Poison Control (1800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse
reactions and institute appropriate symptomatic treatment immediately.
6

11 DESCRIPTION
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. 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.

12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
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 therelease of proinflammatory cytokines and chemokines.

12.3 Pharmacokinetics
After a single dose, nemolizumab-ilto exposure increased dose proportionally over a dose range of 0.03 and 3
mg/kg following subcutaneous administration. After multiple doses, nemolizumab-ilto systemic exposure
increased in an approximately dose-proportional manner across the subcutaneous dose range up to 30 mg. There
was a decrease in bioavailability by 9% with the 60 mg subcutaneous dose and by 15% with the 90 mg
subcutaneous dose.
Following multiple doses of NEMLUVIO in subjects with prurigo nodularis, the estimated mean (SD) steadystate trough concentrations of nemolizumab-ilto were 3.04 (1.23) µg/mL in subjects with bodyweight less than
90 kg; and 3.66 (1.63) µg/mL in subjects with bodyweight of 90 kg or more. Steady state nemolizumab-ilto
concentrations were achieved by week 4 in subjects weighting less than 90 kg and by week 12 in subjects weighing
90 kg or more.
Absorption
Following an initial subcutaneous dose of 60 mg, nemolizumab-ilto reached peak mean (SD) concentrations(Cmax) of 7.5 (2.31) µg/mL by approximately 6 days post dose.
Distribution
The volume of distribution of nemolizumab-ilto was estimated to be 7.67 L.
Elimination
Nemolizumab-ilto is expected to be degraded in the same manner as endogenous IgG. The terminal elimination
half-life (SD) of nemolizumab-ilto was estimated to be 18.9 (4.96) days and systemic clearance was estimated tobe 0.263 L/day.
7

Metabolism
The metabolic pathway of nemolizumab-ilto has not been characterized. Nemolizumab-ilto is expected to be
degraded into small peptides by catabolic pathways.
Specific Populations
Geriatric Populations
No clinically significant difference in the pharmacokinetics of nemolizumab-ilto was estimated based on age(subjects 18 to 65 years of age and older than 65 years of age). Dose adjustment in this population is notneeded.
Renal or Hepatic Impairment
No clinically significant differences in the pharmacokinetics of nemolizumab-ilto were estimated based on mild
to moderate renal or hepatic impairments. The effect of severe renal and severe hepatic impairments on thepharmacokinetics of nemolizumab-ilto is unknown.
Body Weight
The exposure of nemolizumab-ilto decreases with increasing body weight. After a 30-mg dose every 4 weeks,
the steady state mean exposure parameters (AUCss, Cmaxss and Ctrough) of subjects with bodyweight of above 87
kg is expected to be 1.7-fold lower than that of subjects weighing below 62 kg.
The variability in systemic exposure due to body weight had a clinically meaningful impact on skin lesion
efficacy (IGA response) but not on pruritus improvement.
Drug Interaction Studies
Drug interactions with nemolizumab-ilto have not been assessed [See Drug Interactions (7)].

12.6 Immunogenicity
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of theassay. 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 ofnemolizumab-ilto or other nemolizumab products.
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.
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.

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of NEMLUVIO.
8

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

14 CLINICAL STUDIES
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 wasdefined 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 asdefined 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 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, theproportion 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 2 and Figures 1, 2, and 3.
Table 2: Efficacy Results at Week 16 in Adult Subjects with PN in OLYMPIA 1 and OLYMPIA 2
OLYMPIA 1

Proportion of subjects withboth an improvement(reduction) of ≥4 frombaseline in PP-NRS and IGA 0
or 1a b
Proportion of subjects with
IGA 0 or 1b

NEMLUVIO(N=190)

Placebo(N=96)

22%a

2%a

26%

7%

OLYMPIA 2
Difference
from Placebo(95% CI)

Difference
from Placebo(95% CI)

NEMLUVIO(N=183)

Placebo(N=91)

15%(8%, 21%)a

25%a

4%a

22%
(14%, 30%)a

15%(7%, 23%)

38%

11%

29%
(19%, 38%)9

Proportion of subjects with an
38%
34%
56%
16%
49%
16%
improvement (reduction) of ≥4
(27%,
48%)
(23%,
45%)
from baseline in PP-NRSb
28%
26%
Proportion of subjects with
32%
4%
31%
7%
(20%, 36%)
(18%, 34%)
PP-NRS <2ba
Not adjusted for multiplicity.
b
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 1: Proportion of Adult Subjects with PN with PP-NRS Improvement ≥4 from Baseline Over Time in
OLYMPIA 1 and OLYMPIA 2aa

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.

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

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.

11Figure 3: Proportion of Adult Subjects with PN with IGA Responsea Over Time in OLYMPIA 1 and OLYMPA 2bab

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

16 HOW SUPPLIED/STORAGE AND HANDLINGHow 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 thediluent, 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.
Presentation
Prefilled Pen

Pack size
Pack of 1 pen

NDC #0299-6220-15

Storage and HandlingStore 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.
12

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 firstremoved from the refrigerator (whichever is earlier).

17 PATIENT COUNSELING INFORMATION
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 toself-injection [see Dosage and Administration (2.4)]. 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 (2.4, 2.5), Instructions for
Use].

•

Inform patients and/or caregivers of proper pen disposal and caution against any reuse of needles. Instructpatients 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 (2.3)].

Manufactured by:
Galderma Laboratories, L.P., Dallas, TX 75201
U.S. License No. 2289
NEMLUVIO® is a trademark of Galderma.
© 2024 Galderma Laboratories, L.P. All rights reserved.
Issue Date: August 2024

13

PATIENT INFORMATIONNEMLUVIO® [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.
It is not known if NEMLUVIO is safe and effective in children under 18 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 not receive 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 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 andinject NEMLUVIO and how to properly store and throw away (dispose of) used NEMLUVIO prefilled pens.
• Use NEMLUVIO exactly as prescribed by your healthcare provider.
• 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 yourcaregiver 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 regularscheduled 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 not receive 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:
o breathing problems or o swelling of the face, lips, mouth, tongue, or o fainting, dizziness, feelingwheezing
throatlightheadedo fast pulse
o swollen lymph nodeso joint paino fevero skin rash (red or rough skin)o nausea or vomitingo general ill feelingo cramps in your stomach area
The most common side effects of NEMLUVIO include:• headache• skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches)
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 77°F (25°C) 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 injected are mixed (reconstituted), NEMLUVIO must be
used within 4 hours or thrown away (discarded).
• Do not heat or put NEMLUVIO into direct sunlight.
• Do not freeze NEMLUVIO.
• If NEMLUVIO 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 havethe 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 health 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 trademark of Galderma.
© 2024 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.

Issued: 08/2024