EBGLYSS lebrikizumab-lbkz 250 mg/2mL Injection, Solution — NDC 0002-7797-11 (Billing 00002-7797-11)
This is a package of EBGLYSS lebrikizumab-lbkz 250 mg/2mL Injection, Solution from Eli Lilly and Company, marketed since Sep 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0002-7797-11 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0002 labeler · 7797 product · 11 package
- Package marketed since
- Sep 13, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0002779711 3
- Medicaid fills, this package
- 488 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 086421
- GCN: 56133
- HICL (First Databank): 049658
- AHFS class code: 84:06.28.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1,777.69 | $3,555.39 / 2 ml |
| Medicare drug plans payPart D · Q2 2026 | $1,916.65 | $3,833.31 / 2 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00002-7797-11 You're viewing this Main listing | 1 SYRINGE in 1 CARTON / 2 mL in 1 SYRINGE | 2024-09-13 | — | Active |
| 00002-7797-61 0002-7797-61 | 1 SYRINGE in 1 CARTON / 2 mL in 1 SYRINGE Sample | 2024-09-13 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of EBGLYSS lebrikizumab-lbkz 250 mg/2mL Injection, Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ebglyss 250 mg/2mL 00002-7772-11 | Eli | 1 syringe | $1,783.520 | — | Availability likely | — |
| Ebglyss 250 mg/2mLthis 00002-7797-11 | Eli | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Sep 13, 2036 |
Is there a biosimilar for EBGLYSS 250 MG/2 ML SYRINGE?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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1.8 mg / 2 mL
UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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6.2 mg / 2 mL
UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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0.6 mg / 2 mL
UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
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119.6 mg / 2 mL
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
More NDCs from Eli Lilly and Company labeler code 00002
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- HUMATROPE Somatropin Kit NDC 0002-8147-01
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
2 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 )
2.1Vaccination Prior to Administration of EBGLYSS Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions ( 5.4 )] .
2.2Recommended 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 )] .
2.3Concomitant 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.
2.4Important 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] .
2.5Missed 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 Cautions ▾
5 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 )
5.1Hypersensitivity 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.
5.2Conjunctivitis 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.
5.3Parasitic (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.
5.4Vaccinations 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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 pla… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation 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.
8.4Pediatric 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.
8.5Geriatric 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. C… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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 ▾
8.4Pediatric 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 ▾
8.5Geriatric 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 ▾
10 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics In clinical studies, lebrikizumab-lbkz reduced the levels of serum periostin, total immunoglobulin E (IgE), CC chemokine ligand (CCL)17 [thymus and activation-regulated chemokine (TARC)], CCL18 [pulmonary and activation-regulated chemokine (PARC)], and CCL13 [monocyte chemotactic protein-4 (MCP-4)]. The clinical relevance of these biomarkers is not completely understood. The effectiveness of the maintenance dosage of EBGLYSS 250 mg every 8 weeks was established using longitudinal exposure-response modeling.
Longitudinal exposure-response model predictions were consistent for EBGLYSS maintenance dosages of 250 mg every 8 weeks and 250 mg every 4 weeks.
12.3Pharmacokinetics Lebrikizumab-lbkz steady-state exposure following either a subcutaneous dose of 250 mg every 2 weeks, every 4 weeks, or every 8 weeks in patients with atopic dermatitis are presented in Table 2 . Lebrikizumab-lbkz exposure increases dose-proportionally over a subcutaneous dose range of 37.5 to 500 mg. Lebrikizumab-lbkz steady state is achieved at Week 4 following the approved recommended loading doses.
Table 2: Lebrikizumab-lbkz Steady-State Exposure Following Subcutaneous Administration in Patients with Atopic Dermatitis C max = Maximum concentration, C avg = Average concentration, C trough = Trough concentration a Following approved recommended loading doses Lebrikizumab-lbkz Dosage a C max C avg C trough 250 mg every 2 weeks 108 mcg/mL 100 mcg/mL 87 mcg/mL 250 mg every 4 weeks 63 mcg/mL 51 mcg/mL 36 mcg/mL 250 mg every 8 weeks 43 mcg/mL 26 mcg/mL 11 mcg/mL Absorption Following a single subcutaneous 250 mg dose of lebrikizumab-lbkz, peak serum concentrations were achieved approximately 7 to 8 days post dose.
The absolute bioavailability for a subcutaneous dose was approximately 86%. Injection site locations did not influence the absorption of lebrikizumab-lbkz. Distribution The lebrikizumab-lbkz steady-state volume of distribution is
5.14L. Metabolism/Elimination Lebrikizumab-lbkz is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The lebrikizumab-lbkz half-life is 24.5 days and clearance is 0.154 L/day.
Lebrikizumab-lbkz exhibits linear elimination that is independent of dose. Specific Populations Age, Sex, Race Age, sex, or race did not have a significant effect on the pharmacokinetics of lebrikizumab-lbkz. Weight Lebrikizumab-lbkz trough concentrations were lower in subjects with higher body weight.
Patients with Renal or Hepatic Impairment Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the pharmacokinetics of lebrikizumab-lbkz have not been conducted. Lebrikizumab-lbkz, as a monoclonal antibody, is not expected to undergo significant hepatic or renal elimination. No clinically significant differences in the pharmacokinetics of lebrikizumab-lbkz were observed in patients with mild or moderate renal impairment.
Drug Interaction Studies The effect of lebrikizumab-lbkz on the PK of co-administered medications has not been studied.
12.6Immunogenicity 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… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism 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 / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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 and Handling ▾
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.
📋 Description ▾
11 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.
💬 Information for Patients ▾
17 PATIENT COUNSELING 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
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Lebrikizumab-lbkz steady-state exposure following either a subcutaneous dose of 250 mg every 2 weeks, every 4 weeks, or every 8 weeks in patients with atopic dermatitis are presented in Table 2 . Lebrikizumab-lbkz exposure increases dose-proportionally over a subcutaneous dose range of 37.5 to 500 mg. Lebrikizumab-lbkz steady state is achieved at Week 4 following the approved recommended loading doses.
Table 2: Lebrikizumab-lbkz Steady-State Exposure Following Subcutaneous Administration in Patients with Atopic Dermatitis C max = Maximum concentration, C avg = Average concentration, C trough = Trough concentration a Following approved recommended loading doses Lebrikizumab-lbkz Dosage a C max C avg C trough 250 mg every 2 weeks 108 mcg/mL 100 mcg/mL 87 mcg/mL 250 mg every 4 weeks 63 mcg/mL 51 mcg/mL 36 mcg/mL 250 mg every 8 weeks 43 mcg/mL 26 mcg/mL 11 mcg/mL Absorption Following a single subcutaneous 250 mg dose of lebrikizumab-lbkz, peak serum concentrations were achieved approximately 7 to 8 days post dose.
The absolute bioavailability for a subcutaneous dose was approximately 86%. Injection site locations did not influence the absorption of lebrikizumab-lbkz. Distribution The lebrikizumab-lbkz steady-state volume of distribution is
5.14L. Metabolism/Elimination Lebrikizumab-lbkz is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The lebrikizumab-lbkz half-life is 24.5 days and clearance is 0.154 L/day.
Lebrikizumab-lbkz exhibits linear elimination that is independent of dose. Specific Populations Age, Sex, Race Age, sex, or race did not have a significant effect on the pharmacokinetics of lebrikizumab-lbkz. Weight Lebrikizumab-lbkz trough concentrations were lower in subjects with higher body weight.
Patients with Renal or Hepatic Impairment Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the pharmacokinetics of lebrikizumab-lbkz have not been conducted. Lebrikizumab-lbkz, as a monoclonal antibody, is not expected to undergo significant hepatic or renal elimination. No clinically significant differences in the pharmacokinetics of lebrikizumab-lbkz were observed in patients with mild or moderate renal impairment.
Drug Interaction Studies The effect of lebrikizumab-lbkz on the PK of co-administered medications has not been studied.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In clinical studies, lebrikizumab-lbkz reduced the levels of serum periostin, total immunoglobulin E (IgE), CC chemokine ligand (CCL)17 [thymus and activation-regulated chemokine (TARC)], CCL18 [pulmonary and activation-regulated chemokine (PARC)], and CCL13 [monocyte chemotactic protein-4 (MCP-4)]. The clinical relevance of these biomarkers is not completely understood. The effectiveness of the maintenance dosage of EBGLYSS 250 mg every 8 weeks was established using longitudinal exposure-response modeling.
Longitudinal exposure-response model predictions were consistent for EBGLYSS maintenance dosages of 250 mg every 8 weeks and 250 mg every 4 weeks.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Atopic Dermatitis Three multicenter, randomized, double-blind, placebo-controlled trials, ADvocate 1, ADvocate 2 and ADhere (NCT04146363, NCT04178967, NCT04250337) enrolled a total of 1062 subjects 12 years of age and older with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s) and who were candidates for systemic therapy. A total of 148 subjects (14%) were 12 to <18 years who weighed at least 40 kg and 914 (86%) were adult subjects. Disease severity was defined by an Investigator's Global Assessment (IGA) score ≥3 in the overall assessment of AD lesions on a severity scale of 0 to 4, an Eczema Area and Severity Index (EASI) score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.
At baseline, 50% of subjects were male, 63% were White, 11% were Black or African American, and 21% were Asian; 12.8% identified as Hispanic or Latino, 63% of subjects had a baseline IGA score of 3 (moderate AD) and 37% of subjects had a baseline IGA of 4 (severe AD). The baseline mean EASI was 29, and the baseline Pruritus Numeric Rating Scale (NRS) was 7 on a scale of 0-10. Of all subjects, 99% had received prior treatment for AD.
In all three trials, subjects in the EBGLYSS group received subcutaneous injections of EBGLYSS 500 mg at Week 0 and at Week 2, followed by 250 mg every other week (Q2W) through Week 16. To evaluate the maintenance and durability of response in the monotherapy trials (ADvocate 1 and ADvocate 2), subjects originally randomized to EBGLYSS who achieved an IGA score of 0 or 1, or at least a 75% reduction in EASI from baseline [EASI-75] at Week 16 and did not require rescue therapy were re-randomized to an additional 36 weeks of either a maintenance dose of EBGLYSS 250 mg Q2W (every 2 weeks), EBGLYSS 250 mg Q4W (every 4 weeks), or placebo.
Subjects who did not achieve IGA 0 or 1 or EASI-75 at Week 16 or subjects who required rescue therapy during the first 16 weeks were treated with open-label EBGLYSS 250 mg Q2W. In the concomitant therapy trial (ADhere), subjects received EBGLYSS + TCS or placebo + TCS. Topical calcineurin inhibitors (TCI) were permitted for sensitive areas only, such as the face, neck, intertriginous and genital areas.
All three trials assessed the primary endpoint, the proportion of subjects who achieved an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-point improvement from baseline at Week 16. Other evaluated outcomes at Week 16 included the proportion of subjects with EASI-75 and EASI-90, and improvement in itch severity as defined by a reduction of at least 4 points on an 11-point Pruritus NRS. ADvocate 1 and ADvocate 2 also evaluated the maintenance and durability of response through Week 52.
The results of the EBGLYSS monotherapy trials (ADvocate 1 and ADvocate 2) are presented in Table 3 . Table 3: Efficacy Results of EBGLYSS Monotherapy at Week 16 a in ADvocate 1 and ADvocate 2 in Subjects with Moderate-to-Severe Atopic Dermatitis a Subjects who received rescue therapy or discontinued treatment due to lack of efficacy were analyzed as non-responders. Data after treatment discontinuation due to any other reason were considered missing.
Any missing data was imputed using MCMC-MI. b Subjects received 500 mg of EBGLYSS at Week 0 and Week 2, and 250 mg Q2W up to Week 16 c Primary endpoint. Responder was defined as a subject with an IGA 0 or 1 (“clear” or “almost clear”) and a reduction of ≥2 points on a 0-4 IGA scale ADvocate 1 ADvocate 2 EBGLYSS 250 mg Q2W b Placebo Difference from Placebo (95% CI) EBGLYSS 250 mg Q2W b Placebo Difference from Placebo (95% CI) Number of subjects 283 141 -- 281 146 -- IGA 0 or 1 c 43% 13% 30% (22%, 38%) 33% 11% 22% (14%, 30%) EASI-75 59% 16% 42% (33%, 51%) 52% 18% 33% (24%, 42%) EASI-90 38% 9% 29% (21%, 36%) 31% 10% 21% (13%, 28%) Number of subjects with baseline Pruritus NRS score ≥4 263 130 -- 253 134 -- Pruritus NRS ≥4 point improvement 46% 13% 33% (25%, 41%) 40% 12… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of lebrikizumab-lbkz. No effects on fertility parameters such as reproductive organs, reproductive hormones or menstrual cycle length were observed in sexually mature female cynomolgus monkeys that were administered intravenous doses of lebrikizumab-lbkz up to 25 mg/kg/week for 37 weeks, which was associated with plasma exposure (C avg,ss ) approximately 15 times the human exposure at the MRHD.
No effects on reproductive organs or sperm analysis were observed in sexually mature male cynomolgus monkeys that were administered subcutaneous doses of lebrikizumab-lbkz up to 25 mg/kg/week for 13 weeks, which was associated with plasma exposure (C avg,ss ) approximately 11 times the human exposure at the MRHD.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of lebrikizumab-lbkz. No effects on fertility parameters such as reproductive organs, reproductive hormones or menstrual cycle length were observed in sexually mature female cynomolgus monkeys that were administered intravenous doses of lebrikizumab-lbkz up to 25 mg/kg/week for 37 weeks, which was associated with plasma exposure (C avg,ss ) approximately 15 times the human exposure at the MRHD.
No effects on reproductive organs or sperm analysis were observed in sexually mature male cynomolgus monkeys that were administered subcutaneous doses of lebrikizumab-lbkz up to 25 mg/kg/week for 13 weeks, which was associated with plasma exposure (C avg,ss ) approximately 11 times the human exposure at the MRHD.
📄 Patient Package Insert ▾
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 02/2026 EBG-0002-PPI-202602 PATIENT INFORMATION EBGLYSS ® (EHB-glihs) (lebrikizumab-lbkz) injection, for subcutaneous use What is EBGLYSS? EBGLYSS is a prescription medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies.
EBGLYSS can be used with or without topical corticosteroids. It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg). Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS.
See the end of this leaflet for a complete list of ingredients in EBGLYSS. Before you use EBGLYSS, tell your healthcare provider about all your medical conditions, including if you: have a parasitic (helminth) infection are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with EBGLYSS. are pregnant or plan to become pregnant.
It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy. are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.
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 EBGLYSS? See the detailed “Instructions for Use” that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes.
Use EBGLYSS exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much EBGLYSS to inject and how often to inject it. EBGLYSS comes as a single-dose prefilled pen or prefilled syringe with needle shield.
EBGLYSS 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 EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider.
In children 12 years of age and older, EBGLYSS should be given by a caregiver. If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time. If you inject too much EBGLYSS (overdose), get medical help or contact a Poison Center expert right away at 1‑800-222-1222.
Your healthcare provider may prescribe other medicines to use with EBGLYSS. Use the other prescribed medicines exactly as your healthcare provider tells you to. What are the possible side effects of EBGLYSS?
EBGLYSS can cause serious side effects, including: Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing swelling of the face, lips, mouth, tongue, or throat hives itching fainting, dizziness, feeling lightheaded skin rash cramps in your stomach area (abdomen) Eye problems.
Tell your healthcare provider if you have any new or worsening eye problems, include eye pain or changes in vision, such as blurred vision. The most common side effects of EBGLYSS include: eye and eyelid inflammation, including redness, swelling, and itching injection site reactions shingles (herpes zoster) These are not all of the possible side effects of EBGLYSS. Call your doctor for… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
PREFILLED PEN INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE EBGLYSS ® [EHB-glihs] (lebrikizumab-lbkz) injection, for subcutaneous use Single-Dose Prefilled Pen This Instructions for Use contains information on how to inject EBGLYSS. Before you use the EBGLYSS Prefilled Pen (Pen), read and carefully follow all the step-by-step instructions. Important information you need to know before injecting EBGLYSS Your healthcare provider should show you how to prepare and inject EBGLYSS using the Pen.
Do not inject yourself or someone else until you have been shown how to inject EBGLYSS. Keep this Instructions for Use and read it as needed. Each EBGLYSS Pen contains 1 dose of EBGLYSS.
The Pen is for one-time use only. The EBGLYSS Pen contains glass parts. Handle it carefully.
If you drop it on a hard surface, do not use it. Use a new EBGLYSS Pen for your injection. Your healthcare provider may help you decide where on your body to inject your dose.
You can also read the Choose and clean your injection site section of these instructions to help you choose which area can work best for you. If you have vision or hearing problems, do not use EBGLYSS Pen without help from a caregiver. See Storing EBGLYSS for important storage information.
INSTRUCTIONS FOR USE Before you use the EBGLYSS Pen, read and carefully follow all the step-by-step instructions. Parts of the EBGLYSS Pen Preparing to inject EBGLYSS Gather supplies and EBGLYSS Pen: EBGLYSS Pen from the refrigerator 1 alcohol wipe 1 cotton ball or piece of gauze 1 sharps disposal container (See Disposing of EBGLYSS ) Note: You do not need to allow your Pen to warm up to room temperature before use. Inspect the Pen and the medicine Leave the gray base cap on until you are ready to inject.
Make sure you have the right medicine. The medicine inside should be clear. It may be colorless to slightly yellow to slightly brown.
Do not use the Pen (see Disposing of EBGLYSS ) if the: Pen looks damaged medicine is frozen medicine is cloudy, is discolored, or has particles expiration date printed on the label has passed Wash your hands with soap and water Choose and clean your injection site Your healthcare provider can help you choose the injection site that is best for you. Clean the injection site with an alcohol wipe and let dry. You or another person may inject into these areas.
Stomach area (abdomen) — At least 2 inches away from the belly button (navel). Front of thigh — At least 2 inches above the knee and 2 inches below the groin. Another person should inject into this area.
Back of upper arm — Another person should inject into the back of your upper arm. Do not inject in the exact same spot every time. Do not inject into areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by eczema (atopic dermatitis) or other skin lesions.
Injecting EBGLYSS 1 Uncap the Pen Make sure the Pen is locked . When you are ready to inject, twist off the gray base cap and throw it away in your household trash. Do not put the gray base cap back on; this could damage the needle.
Do not touch the needle inside the clear base. 2 Place and unlock Place and hold the clear base flat and firmly against the skin. Keep the clear base on the skin, then turn the lock ring to the unlock position.
3 Press and hold for 15 seconds Press and hold the purple injection button and listen for 2 loud clicks: First click: injection started Second click: injection completed The injection may take up to 15 seconds. You will know the injection is complete when the gray plunger is visible. Disposing of EBGLYSS Dispose of (throw away) the used Pen Put the used EBGLYSS Pen in an FDA-cleared sharps disposal container right away after use.
Do not throw away (dispose of) the EBGLYSS Pen in your household trash. 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 sharp… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Dosage and Administration, single-dose prefilled syringe warming instructions ( 2.4 ) removed 10/2025 Dosage and Administration ( 2.2 ) 06/2026
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL – Ebglyss 250 mg Prefilled Pen Ebglyss ® (lebrikizumab-lbkz) injection 250 mg / 2 mL 1 Single-Dose Prefilled Pen NDC 0002-7772-11 1 x 250 mg/2 mL Single-Dose Prefilled Pen For Subcutaneous Use Only Rx only Lilly Ebglyss 250 mg Prefilled Pen Carton
PACKAGE LABEL – Ebglyss 250 mg Prefilled Syringe Ebglyss ® (lebrikizumab-lbkz) injection 250 mg / 2 mL 1 Single-Dose Prefilled Syringe with Needle Shield NDC 0002-7797-11 1 x 250 mg/2 mL (125 mg/mL) Single-Dose Prefilled Syringe with Needle Shield For Subcutaneous Use Only Rx only Lilly Ebglyss 250 mg Prefilled Syringe Carton
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| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
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