Ebglyss (lebrikizumab-lbkz): Uses, Dosage, Side Effects & Warnings

Uses

1 INDICATIONS AND USAGE EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids. EBGLYSS ® is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids. ( 1 )

Dosage and administration

Prior to EBGLYSS treatment, complete all age-appropriate vaccinations according to current immunization guidelines. ( 2.1 ) The recommended dosage of EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg (one injection) every 2 weeks until Week 16 or later, when adequate clinical response is achieved. The maintenance dose of EBGLYSS is 250 mg every 4 weeks or 250 mg every 8 weeks. ( 2.2 ) Administer by subcutaneous injection. ( 2.4 ) 2.1 Vaccination Prior to Administration of EBGLYSS Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions ( 5.4 )] . 2.2 Recommended Dosage The recommended subcutaneous dosage of EBGLYSS is an initial dose of 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later, when adequate clinical response is achieved. The maintenance dosage of EBGLYSS is 250 mg every four weeks or 250 mg every eight weeks [see Pharmacodynamics ( 12.2 ) and Clinical Studies ( 14.1 )] . 2.3 Concomitant Topical Therapies EBGLYSS can be used with or without topical corticosteroids (TCS). Topical calcineurin inhibitors (TCI) may be used, but reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas. 2.4 Important Administration Instructions EBGLYSS is for subcutaneous administration. EBGLYSS is intended for use under the guidance of a healthcare professional. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of EBGLYSS. Adult patients may self-inject, or caregivers may give EBGLYSS after training in subcutaneous injection technique. For pediatric patients, caregivers may give injections after training in subcutaneous injection technique. Sites for injection include the abdomen, thigh, and back of the upper arm. Administration of EBGLYSS in the back of the upper arm may be performed by a caregiver or healthcare provider. Alternate the injection site with each injection. Do not inject EBGLYSS within 2 inches (5 cm) of the navel or into areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by atopic dermatitis or skin lesions. It is not necessary to allow EBGLYSS prefilled pen or EBGLYSS prefilled syringe to warm up to room temperature before use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EBGLYSS is a clear to opalescent, colorless to slightly yellow to slightly brown solution. Do not use if the liquid contains visible particles, is discolored or cloudy [see Dosage Forms and Strengths ( 3 ), How Supplied/Storage and Handling ( 16 )] . Refer to the Instructions for Use for complete administration instructions with illustrations [see Instructions for Use] . 2.5 Missed Dose If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Dosage forms and strengths

3 DOSAGE FORMS AND STRENGTHS EBGLYSS is a clear to opalescent, colorless to slightly yellow to slightly brown solution available as follows: Injection: 250 mg/2 mL in a single-dose prefilled pen Injection: 250 mg/2 mL (125 mg/mL) in a single-dose prefilled syringe with needle shield Injection: 250 mg/2 mL in a single-dose prefilled pen ( 3 ) 250 mg/2 mL (125 mg/mL) in a single-dose prefilled syringe with needle shield ( 3 )

Contraindications

4 CONTRAINDICATIONS EBGLYSS is contraindicated in patients with prior serious hypersensitivity to lebrikizumab-lbkz or any excipients of EBGLYSS [see Warnings and Precautions ( 5.1 )] . Prior serious hypersensitivity to lebrikizumab-lbkz or any excipients in EBGLYSS. ( 4 )

Warnings and precautions

Hypersensitivity: Hypersensitivity reactions including angioedema and urticaria, have occurred after administration of EBGLYSS. Discontinue EBGLYSS in the event of a serious hypersensitivity reaction. ( 5.1 ) Conjunctivitis and Keratitis: Report new onset or worsening eye symptoms to a healthcare provider. ( 5.2 ) Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating EBGLYSS. If patients become infected while receiving EBGLYSS and do not respond to anti-helminth treatment, discontinue treatment with EBGLYSS until the infection resolves. ( 5.3 ) Vaccinations: Avoid use of live vaccines during treatment with EBGLYSS. ( 5.4 ) 5.1 Hypersensitivity Hypersensitivity reactions, including angioedema and urticaria, have been reported with use of EBGLYSS. If a serious hypersensitivity reaction occurs, discontinue EBGLYSS and institute appropriate therapy. 5.2 Conjunctivitis and Keratitis Conjunctivitis and keratitis adverse reactions have been reported in clinical trials. Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received EBGLYSS compared to those who received placebo. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered during the treatment period [see Adverse Reactions ( 6.1 )] . Advise patients to report new onset or worsening eye symptoms to their healthcare provider. 5.3 Parasitic (Helminth) Infections Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if EBGLYSS will influence the immune response against helminth infections by inhibiting IL-13 signaling. Treat patients with pre-existing helminth infections before initiating treatment with EBGLYSS. If patients become infected while receiving EBGLYSS and do not respond to antihelminth treatment, discontinue treatment with EBGLYSS until the infection resolves. 5.4 Vaccinations EBGLYSS may alter a patient’s immunity and increase the risk of infection following administration of live vaccines. Prior to therapy with EBGLYSS, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines immediately prior to or during treatment with EBGLYSS. No data are available on the response to live vaccines.

Side effects

The following adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions ( 5.1 )] Conjunctivitis and Keratitis [see Warnings and Precautions ( 5.2 )] Most common (≥1%) adverse reactions are conjunctivitis, injection site reactions, and herpes zoster. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) 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 and controlled 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. Atopic Dermatitis The safety of EBGLYSS was evaluated across 4 randomized, double-blind, placebo-controlled, multicenter trials in subjects with moderate-to-severe atopic dermatitis including 3 phase 3 trials (ADvocate 1, ADvocate 2, ADhere) and 1 phase 2 dose ranging trial (KGAF). In these 4 trials, mean age was 37 years; 50% of subjects were male; 62% were White, 13% were Black, and 20% were Asian. In terms of co-morbid conditions, in the phase 3 trials, 30% of the subjects had asthma, 50% had allergic rhinitis, 31% had food allergy, and 14% had allergic conjunctivitis at baseline. A total of 891 subjects were treated with EBGLYSS for at least 1 year in the atopic dermatitis development program. ADvocate 1, ADvocate 2, and KGAF compared the safety of EBGLYSS monotherapy to placebo. ADhere compared the safety of EBGLYSS + TCS to placebo + TCS through 16 weeks. All subjects from the phase 3 trials were allowed to enroll in the long-term extension study. Weeks 0 to 16 Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% in the EBGLYSS 250 mg every 2 weeks monotherapy group, or in the EBGLYSS 250 mg every 2 weeks + TCS group, all at a higher rate than placebo during the first 16 weeks of treatment. Table 1: Adverse Reactions Occurring in ≥1% of the EBGLYSS Monotherapy Group or the EBGLYSS + TCS Group in the Atopic Dermatitis Trials through Week 16 a Integrated analysis of ADvocate 1, ADvocate 2, and the phase 2 dose finding trial (KGAF) b Analysis of TCS concomitant therapy trial ADhere c EBGLYSS 500 mg at Week 0 and Week 2, followed by 250 mg every two weeks d Conjunctivitis cluster includes conjunctivitis, conjunctivitis allergic, and conjunctivitis bacterial e Injection Site Reactions cluster includes injection site-related: pain, erythema, reaction, discomfort, dermatitis, pruritus, swelling, and rash Adverse Reactions EBGLYSS Monotherapy a EBGLYSS + TCS b EBGLYSS 250 mg Q2W c N = 638 n (%) Placebo N = 338 n (%) EBGLYSS 250 mg Q2W c + TCS N = 145 n (%) Placebo + TCS N = 66 n (%) Conjunctivitis d 61 (10) 10 (3) 7 (5) 0 Injection Site Reactions e 16 (3) 4 (1) 4 (3) 1 (2) Herpes Zoster 3 (<1) 0 2 (1) 0 In the monotherapy trials (ADvocate 1, ADvocate 2, and KGAF) through Week 16, the proportion of subjects who discontinued treatment due to adverse events was 2.4% in the EBGLYSS 250 mg every 2 weeks group and 1.8% in the placebo group. In the TCS trial (ADhere) through Week 16, the proportion of subjects who discontinued treatment due to adverse events was 2.1% in the EBGLYSS 250 mg every 2 weeks + TCS group and 0% in the placebo + TCS group. The most common adverse reactions leading to discontinuation of EBGLYSS compared to the placebo group were conjunctivitis and keratitis (0.6% vs. 0.3%), and injection site reactions (0.2% vs. 0) in the monotherapy trials; and conjunctivitis (0.7% vs. 0), and injection site reactions (0.7% vs. 0) in the TCS trial. Eosinophilia Increased post-baseline blood eosinophils were observed at a higher frequency in EBGLYSS-treated subjects compared to placebo. During the first 16 weeks, eosinophilia (>5000 cells/mcL) was observed in 0.4% in the EBGLYSS-treated subjects and 0% in subjects receiving placebo. Blood eosinophil elevations were generally transient and did not result in discontinuation. Safety Weeks 16 to 52 Among those EBGLYSS-treated subjects who responded at Week 16 and who were re-randomized in the maintenance period of the monotherapy trials ADvocate 1 and ADvocate 2, a total of 113 and 118 subjects received EBGLYSS 250 mg every 2 weeks or every 4 weeks, respectively. The safety profile of EBGLYSS 250 mg every 4 weeks was generally consistent with EBGLYSS every 2 weeks during Weeks 16 to 52. The safety profile of EBGLYSS during maintenance treatment was generally consistent with the safety profile observed through Week 16. Specific Adverse Drug Reactions Conjunctivitis and Keratitis Conjunctivitis was the most frequently reported eye disorder. Most cases of conjunctivitis and keratitis were mild or moderate in severity and recovered or resolved without treatment interruption or discontinuation. During the initial 16-week treatment period of the monotherapy trials, conjunctivitis, including allergic conjunctivitis, was reported by 61 subjects (10%) in the EBGLYSS 250 mg every 2 weeks group and 10 subjects (3%) in the placebo group. In the TCS concomitant therapy trial, conjunctivitis was reported by 7 subjects (5%) in the EBGLYSS 250 mg every 2 weeks + TCS group compared to 0% in the placebo + TCS group. During the 16-week placebo-controlled induction period, 68 subjects reported 73 events of conjunctivitis. All events were nonserious and mild or moderate in severity. Conjunctivitis led to treatment discontinuation in 3 subjects. The exposure adjusted incidence rate of conjunctivitis for subjects treated with EBGLYSS 250 mg every 2 weeks was 30.6 events per 100 patient years through Week 16 (KGAF, ADvocate 1, ADvocate 2, ADhere).

Use in specific populations

8.1 Pregnancy Risk Summary Available data on lebrikizumab-lbkz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations) . In animal reproduction studies, no effects on embryo-fetal development were observed after subcutaneous administration of lebrikizumab-lbkz to cynomolgus monkeys during organogenesis at doses up to 18 times the human exposure at the maximum recommended human dose (MRHD) (see Data) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. 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. Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). 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, EBGLYSS may be present in infants exposed in utero. The potential clinical impact of EBGLYSS exposure in infants exposed in utero should be considered. Data Animal Data In an embryofetal development study, no malformations or embryofetal toxicity were observed in fetuses from pregnant cynomolgus monkeys administered lebrikizumab-lbkz during organogenesis at doses up to 150 mg/kg initial dose followed by 50 mg/kg per week by subcutaneous injection, which was associated with plasma exposure (C avg,ss ) approximately 18 times the human exposure at the MRHD. Lebrikizumab-lbkz crossed the placenta in monkeys. In a prenatal and postnatal development study, pregnant cynomolgus monkeys were administered lebrikizumab-lbkz during organogenesis to parturition at doses up to 150 mg/kg initial dose followed by 50 mg/kg per week by subcutaneous injection, which was associated with plasma exposure (C avg,ss ) approximately 18 times the human exposure at the MRHD. No embryofetal toxicity or malformations, or effects on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age. 8.2 Lactation Risk Summary There are no data on the presence of lebrikizumab-lbkz in human milk, the effects on the breastfed infant, or the effects on milk production. Endogenous IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to lebrikizumab-lbkz are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EBGLYSS and any potential adverse effects on the breastfed infant from EBGLYSS or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of EBGLYSS have been established in pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. A total of 372 pediatric subjects were exposed to EBGLYSS with 270 subjects exposed to EBGLYSS for at least one year. The safety and effectiveness were generally consistent between pediatric and adult subjects [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.1 )] . The safety and effectiveness of EBGLYSS have not been established in pediatric patients younger than 12 years of age and pediatric patients 12 years and older who weigh less than 40 kg. 8.5 Geriatric Use Of the 1348 adult subjects with moderate-to-severe atopic dermatitis exposed to EBGLYSS, a total of 123 were 65 years and older, and 29 subjects were 75 years and older. Clinical studies of EBGLYSS did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects [see Clinical Pharmacology ( 12.3 )] .

Pregnancy

8.1 Pregnancy Risk Summary Available data on lebrikizumab-lbkz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations) . In animal reproduction studies, no effects on embryo-fetal development were observed after subcutaneous administration of lebrikizumab-lbkz to cynomolgus monkeys during organogenesis at doses up to 18 times the human exposure at the maximum recommended human dose (MRHD) (see Data) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. 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. Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). 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, EBGLYSS may be present in infants exposed in utero. The potential clinical impact of EBGLYSS exposure in infants exposed in utero should be considered. Data Animal Data In an embryofetal development study, no malformations or embryofetal toxicity were observed in fetuses from pregnant cynomolgus monkeys administered lebrikizumab-lbkz during organogenesis at doses up to 150 mg/kg initial dose followed by 50 mg/kg per week by subcutaneous injection, which was associated with plasma exposure (C avg,ss ) approximately 18 times the human exposure at the MRHD. Lebrikizumab-lbkz crossed the placenta in monkeys. In a prenatal and postnatal development study, pregnant cynomolgus monkeys were administered lebrikizumab-lbkz during organogenesis to parturition at doses up to 150 mg/kg initial dose followed by 50 mg/kg per week by subcutaneous injection, which was associated with plasma exposure (C avg,ss ) approximately 18 times the human exposure at the MRHD. No embryofetal toxicity or malformations, or effects on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age.

Pediatric use

8.4 Pediatric Use The safety and effectiveness of EBGLYSS have been established in pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. A total of 372 pediatric subjects were exposed to EBGLYSS with 270 subjects exposed to EBGLYSS for at least one year. The safety and effectiveness were generally consistent between pediatric and adult subjects [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.1 )] . The safety and effectiveness of EBGLYSS have not been established in pediatric patients younger than 12 years of age and pediatric patients 12 years and older who weigh less than 40 kg.

Geriatric use

8.5 Geriatric Use Of the 1348 adult subjects with moderate-to-severe atopic dermatitis exposed to EBGLYSS, a total of 123 were 65 years and older, and 29 subjects were 75 years and older. Clinical studies of EBGLYSS did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects [see Clinical Pharmacology ( 12.3 )] .

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

Lebrikizumab-lbkz, an interleukin-13 antagonist, is an immunoglobulin G4 (IgG4) monoclonal antibody that binds to interleukin (IL)-13 and inhibits IL-13 signaling. Lebrikizumab-lbkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. Lebrikizumab-lbkz has an approximate molecular weight of 145 kDa. EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution for subcutaneous use. EBGLYSS is available as either a 250 mg/2 mL single-dose prefilled pen or a single-dose prefilled syringe with needle shield. The EBGLYSS prefilled pen and prefilled syringe with needle shield are not made with natural rubber latex. Each prefilled pen or prefilled syringe delivers 250 mg lebrikizumab-lbkz in 2 mL solution which also contains glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0.

Mechanism of action

12.1 Mechanism of Action Lebrikizumab-lbkz is an IgG4 monoclonal antibody that binds with high affinity and slow off-rate to interleukin (IL)-13 and allows IL-13 to bind to IL-13Rα1 but inhibits human IL-13 signaling through the IL-4Rα/IL-13Rα1 receptor complex. IL-13 is a naturally occurring cytokine that is involved in Type 2 inflammation, which is an important component in the pathogenesis of atopic dermatitis. Lebrikizumab-lbkz inhibits IL-13-induced responses including the release of proinflammatory cytokines, chemokines and IgE. Lebrikizumab-lbkz-bound IL-13 can still bind IL-13Rα2 allowing subsequent internalization and natural clearance of IL-13.

How supplied

How Supplied EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution, available in a single-dose prefilled pen or a single-dose prefilled syringe with needle shield. Each prefilled pen and prefilled syringe with needle shield is designed to deliver 250 mg of EBGLYSS in 2 mL. EBGLYSS is supplied as: Pack Size NDC Prefilled Pen 250 mg/2 mL single-dose Carton of 1 0002-7772-11 Prefilled syringe with needle shield 250 mg/2 mL (125 mg/mL) single-dose Carton of 1 0002-7797-11 Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F). If necessary, EBGLYSS can be stored at room temperature up to 30°C (86°F) for up to 7 days in the original carton. Dispose of EBGLYSS that has been left at room temperature for longer than 7 days. Store in the original carton to protect from light until use. Do not freeze. Do not use EBGLYSS if it has been frozen. Do not shake. Do not microwave, run hot water over it, or leave it in direct sunlight. Not made with natural rubber latex. Discard the EBGLYSS single-dose prefilled pen or prefilled syringe with needle shield after use in a puncture-resistant container. How Supplied EBGLYSS (lebrikizumab-lbkz) injection is a sterile, preservative free, clear to opalescent, colorless to slightly yellow to slightly brown solution, available in a single-dose prefilled pen or a single-dose prefilled syringe with needle shield. Each prefilled pen and prefilled syringe with needle shield is designed to deliver 250 mg of EBGLYSS in 2 mL. EBGLYSS is supplied as: Pack Size NDC Prefilled Pen 250 mg/2 mL single-dose Carton of 1 0002-7772-11 Prefilled syringe with needle shield 250 mg/2 mL (125 mg/mL) single-dose Carton of 1 0002-7797-11

Storage

Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F). If necessary, EBGLYSS can be stored at room temperature up to 30°C (86°F) for up to 7 days in the original carton. Dispose of EBGLYSS that has been left at room temperature for longer than 7 days. Store in the original carton to protect from light until use. Do not freeze. Do not use EBGLYSS if it has been frozen. Do not shake. Do not microwave, run hot water over it, or leave it in direct sunlight. Not made with natural rubber latex. Discard the EBGLYSS single-dose prefilled pen or prefilled syringe with needle shield after use in a puncture-resistant container.

Patient information

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Instructions: Provide guidance to patients and caregivers on proper subcutaneous injection technique, including aseptic technique, and how to use the prefilled pen and prefilled syringe correctly. Advise patients to follow sharps disposal recommendations [see Dosage and Administration ( 2.4 ), Instructions for Use] . Hypersensitivity: Advise patients to discontinue EBGLYSS and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . Conjunctivitis and Keratitis: Advise patients to consult their healthcare provider if new onset or worsening eye symptoms develop [see Warnings and Precautions ( 5.2 )] . Parasitic (Helminth) Infections: Advise patients to notify their healthcare provider if they present with clinical features consistent with helminthic infection [see Warnings and Precautions ( 5.3 )] . Vaccinations: Advise patients that EBGLYSS may increase the risk of infection following administration of live vaccines and that vaccination with live vaccines is not recommended during EBGLYSS treatment. Instruct patients to inform the healthcare provider that they are taking EBGLYSS prior to a potential vaccination [see Warnings and Precautions ( 5.4 )] . Pregnancy: Inform patients to report their pregnancy to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) [see Use in Specific Populations ( 8.1 )] . Eli Lilly and Company, Indianapolis, IN 46285, USA US License No. 1891 Copyright © 2024, 2026, Eli Lilly and Company. All rights reserved. Pat.: www.lilly.com/patents EBG-0006-USPI-20260609

Active ingredients

Lebrikizumab in 2 products

Ebglyss NDC products (2)

NDC	Strength & form	Labeler	Type
0002-7772	Lebrikizumab 250 mg/2mL Injection, Solution	Eli Lilly and Company	BLA
0002-7797	Lebrikizumab 250 mg/2mL Injection, Solution	Eli Lilly and Company	BLA

Frequently asked questions

What is Ebglyss used for?

1 INDICATIONS AND USAGE EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids. EBGLYSS ® is an…

What are the side effects of Ebglyss?

The following adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions ( 5.1 )] Conjunctivitis and Keratitis [see Warnings and Precautions ( 5.2 )] Most common (≥1%) adverse reactions are conjunctivitis, injection site reactions, and herpes zoster. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx… See the full label for the complete list.

Who makes Ebglyss?

Ebglyss is listed by 1 labeler in the FDA NDC directory, including Eli Lilly and Company.