Nemluvio

nemolizumab-ilto · Injection, Powder, Lyophilized, For Solution · Subcutaneous

Prescription (Rx) Interleukin-31 Receptor alpha Antagonist

Uses

1 INDICATIONS AND USAGE 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 ) 1.1 Prurigo Nodularis NEMLUVIO is indicated for the treatment of adults with prurigo nodularis. 1.2 Atopic Dermatitis 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.

Dosage and administration

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 ) 2.1 Vaccination Prior to Treatment Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO [ see Warnings and Precautions (5.2) ]. 2.2 Recommended Dosage for Prurigo Nodularis 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. 2.3 Recommended Dosage for Atopic Dermatitis 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. 2.4 Missed Dose If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. 2.5 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. 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 ]. 2.6 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. 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.

Dosage forms and strengths

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. For injection: single-dose, prefilled, dual-chamber pen containing 30 mg of nemolizumab-ilto lyophilized powder and diluent, water for injection. ( 3 )

Contraindications

4 CONTRAINDICATIONS 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) ]. Known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. ( 4 )

Warnings and precautions

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 ) 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 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) ]. 5.2 Vaccinations 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.

Side effects

The following clinically significant adverse reactions are described in greater details elsewhere in the labeling: Hypersensitivity [ see Warnings and Precautions (5.1) ] Most common adverse reactions are: Prurigo Nodularis (incidence ≥1%): headache, dermatitis atopic, eczema, and eczema nummular. ( 6.1 ) Atopic Dermatitis (incidence ≥1%): headache (including migraine), arthralgia, urticaria, and myalgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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. Prurigo Nodularis 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 the drug development program for prurigo nodularis. The safety of NEMLUVIO in adult subjects with prurigo nodularis was evaluated in two randomized, doubleblind, placebo-controlled, multicenter trials (OLYMPIA 1 and OLYMPIA 2). 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 [ see Clinical Studies (14.1 )]. Subjects weighing less than 90 kg in the NEMLUVIO group received an initial NEMLUVIO dose of 60 mg or placebo at Week 0, followed by a NEMLUVIO dose of 30 mg or placebo every 4 weeks. Subjects weighing 90 kg or more in the NEMLUVIO group received an initial NEMLUVIO dose of 60 mg or placebo at Week 0 followed by a NEMLUVIO dose of 60 mg or placebo every 4 weeks. During the treatment period in 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 the placebo 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. *includes: headache and tension headache Adverse Reaction NEMLUVIO N= 370 n (%) Placebo (N= 186) n (%) Headache* 23 (6) 6 (3) Dermatitis atopic 16 (4) 1 (0.5) Eczema 14 (4) 3 (2) Eczema nummular 11 (3) 0 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) ]. Atopic Dermatitis Adults and Pediatric Subjects 12 Years of Age and Older A total of 1148 subjects, including 180 subjects 12 to 17 years of age, with moderate-to-severe atopic dermatitis were treated with NEMLUVIO for at least 1 year during the drug development program. The safety of NEMLUVIO was evaluated in a pool of two randomized, double-blind, placebo-controlled, multicenter phase 3 trials (ARCADIA 1, ARCADIA 2). In these two trials, 1135 adult and pediatric subjects 12 years of age and older with moderate-to-severe AD were treated with subcutaneous injections of NEMLUVIO (initial dose of 60 mg, followed by 30 mg every 4 weeks), with concomitant topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) for up to 16 weeks (Initial Treatment Period) [ see Clinical Studies (14.2 )]. After the Initial Treatment Period, subjects who responded to NEMLUVIO were re-randomized to receive NEMLUVIO 30 mg every 4 weeks, NEMLUVIO 30 mg every 8 weeks, or placebo every 4 weeks for the Maintenance Treatment Period (Week 16 through Week 48) [see Clinical Studies (14.2)] . The safety population during the Maintenance Treatment Period had a mean age of 31 to 33 years (median age of 26 to 29 years) for the NEMLUVIO cohorts. Week 0 to Week 16 In ARCADIA 1 and ARCADIA 2 trials through Week 16, the proportion of subjects who discontinued treatment because of adverse events was 2.3% in the NEMLUVIO every 4 weeks group and 2.2% in the placebo groups. Table 2 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 during the first 16 weeks of treatment. Table 2: Adverse Reactions Occurring in ≥1% of Adult and Pediatric Subjects 12 Years of Age and Older with Atopic Dermatitis in the NEMLUVIO Group and Greater than in the Placebo Group in ARCADIA 1 and ARCADIA 2 Trials through Week 16 Adverse reactions NEMLUVIO N = 1135 n (%) Placebo N=584 n (%) Headache (incl. migraine) 52 (5) 22 (4) Arthralgia 12 (1) 1 (0.2) Urticaria 12 (1) 2 (0.3) Myalgia 11 (1) 1 (0.2) Assessment of the safety profile of NEMLUVIO in 505 subjects up through Week 48 in the ARCADIA 1 and ARCADIA 2 trials was generally consistent with the safety profile observed at Week 16. Specific Adverse Reactions Hypersensitivity reactions Type 1 hypersensitivity reactions (Ig-E mediated reactions) were reported in subjects treated with NEMLUVIO. This included occurrence of mild urticaria that did not lead to discontinuation of treatment. Injection site reactions The incidence of injection site reactions during the initial treatment period was reported for 1.2% of subjects treated with NEMLUVIO and 0.9% of subjects receiving placebo; during the maintenance period, the incidence was 0.6% with NEMLUVIO every 4 weeks, 0% with NEMLUVIO every 8 weeks, and 0% with placebo. None of these reactions led to discontinuation of treatment.

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. 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. Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, NEMLUVIO may be present in infants exposed in utero. The potential impact of infants being exposed in utero to NEMLUVIO should be considered. Data Animal Data In an enhanced pre- and postnatal development study, subcutaneous doses up to 25 mg/kg of nemolizumab-ilto were 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 for PN and 50 times for AD, 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 for PN and 50 times for AD, 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 (122 times the MRHD for PN and 168 times for AD, 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 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. 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 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. 8.5 Geriatric Use 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) ].

Pregnancy

Pediatric use

8.4 Pediatric Use 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.

Geriatric use

8.5 Geriatric Use 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) ].

Overdosage

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.

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 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.

Mechanism of action

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 the release of proinflammatory cytokines and chemokines.

How supplied

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: Presentation Pack size NDC# Prefilled Pen Pack of 1 pen 0299-6220-15 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).

Patient information

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: o breathing problems or wheezing o swelling of the face, lips, mouth, tongue, or throat o fainting, dizziness, feeling lightheaded o fast pulse o swollen lymph nodes o joint pain o fever o skin rash (red or rough skin) o nausea or vomiting o general ill feeling o cramps in your stomach area 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.

Label text from the FDA structured product label by Galderma Laboratories, L.P. (revised Jun 26, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Nemolizumab in 1 product

Nemluvio NDC products (1)

NDC	Strength & form	Labeler	Type
0299-6220	Nemolizumab 30 mg/100mg Injection, Powder, Lyophilized, For Solution	Galderma Laboratories, L.P.	BLA

Frequently asked questions

What is Nemluvio used for?

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Who makes Nemluvio?

Nemluvio is listed by 1 labeler in the FDA NDC directory, including Galderma Laboratories, L.P..