Lebrikizumab-lbkz (Monograph)

Brand name: EbglyssTM
Drug class: Immunomodulatory Agents

Medically reviewed by Drugs.com on Apr 10, 2025. Written by ASHP.

Introduction

Recombinant humanized IgG₄ monoclonal antibody that binds specifically to interleukin 13 (IL-13).

Uses for Lebrikizumab-lbkz

Atopic Dermatitis

Treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients ≥12 years of age weighing at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Can be used with or without topical corticosteroids.

Guidelines from the American Academy of Dermatology (AAD) and other experts recommend the use of emollients/moisturizers, topical corticosteroids, and topical calcineurin inhibitors for management of atopic dermatitis; systemic options such as biologics (e.g., dupilumab, tralokinumab) and Janus kinase (JAK) inhibitors may be considered for advanced disease, but systemic corticosteroids are generally not recommended. Specific recommendations for use of lebrikizumab not yet provided in these guidelines.

Lebrikizumab-lbkz Dosage and Administration

General

Pretreatment Screening

Complete all age-appropriate vaccinations per current immunization guidelines.
Treat pre-existing helminth infections prior to starting therapy.

Patient Monitoring

Monitor for symptoms of keratitis or conjunctivitis (e.g., redness, pain, changes in vision).

Other General Considerations

For the treatment of atopic dermatitis, lebrikizumab-lbkz can be administered with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only (e.g., face, neck, intertriginous and genital areas).

Administration

Sub-Q Administration

Administer by sub-Q injection only.

Available as a 250 mg/2 mL single-dose prefilled pen and as a 250 mg/2 mL single-dose prefilled syringe with a needle shield.

Before injecting, remove the drug from the refrigerator. The prefilled pen may be used immediately and does not require warming. The prefilled syringe requires warming before injection. Keeping the needle cap on the prefilled syringe, allow it to reach room temperature for approximately 45 minutes. Ensure the solution in both the prefilled pen and prefilled syringe is clear to opalescent and colorless to slightly yellow or brown without particles or discoloration before injection.

Train patients and caregivers in preparation and administration before self-injection.

In pediatric patients ≥12 years of age, the drug should be administered by or under supervision of a trained adult or caregiver.

Administer sub-Q injections into abdomen, thigh, or back of the upper arm; avoid the 2 inch area around the navel and areas where skin is tender, bruised, red, hard, or affected by atopic dermatitis or lesions. Upper arm injections must be performed by a caregiver or healthcare provider.

Rotate injection sites with each injection.

Dosage

Pediatric Patients

Atopic Dermatitis

Sub-Q

Pediatric patients ≥12 years of age who weigh ≥40 kg: Initially, 500 mg (two 250-mg injections) at week 0 and week 2, followed by 250 mg every 2 weeks until week 16 or later, when adequate clinical response is achieved. Maintenance dosage is 250 mg every 4 weeks.

If a dose is missed, administer as soon as possible, and then resume regular dosing schedule.

Adults

Atopic Dermatitis

Sub-Q

Adults who weigh ≥40 kg: Initially, 500 mg (two 250-mg injections) at week 0 and week 2, followed by 250 mg every 2 weeks until week 16 or later, when adequate clinical response is achieved. Maintenance dosage is 250 mg every 4 weeks.

If a dose is missed, administer as soon as possible, and then resume regular dosing schedule.

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

No specific dosage recommendations.

Cautions for Lebrikizumab-lbkz

Contraindications

Known hypersensitivity to lebrikizumab-lbkz or any of the excipients in the formulation.

Warnings/Precautions

Warnings

Hypersensitivity

Hypersensitivity reactions (e.g., angioedema, urticaria) reported. Discontinue lebrikizumab-lbkz and administer appropriate therapy if serious hypersensitivity reaction occurs.

Conjunctivitis and Keratitis

Conjunctivitis and keratitis reported, with conjunctivitis being the most common eye disorder. Patients should report new or worsening eye symptoms to their healthcare provider.

Parasitic (Helminth) Infections

Lebrikizumab-lbkz has not been studied in patients with helminth infections; treat pre-existing infections before initiating therapy and discontinue if new infections unresponsive to antihelminth treatment occur until the infection is resolved.

Vaccinations

Complete age-appropriate vaccines before starting lebrikizumab-lbkz. Avoid live vaccines immediately before and during treatment.

Immunogenicity

Anti-drug antibodies and neutralizing antibodies detected. The presence of anti-drug antibodies was not associated with changes to the pharmacokinetics, efficacy, or safety of lebrikizumab-lbkz.

Specific Populations

Pregnancy

Insufficient data to determine risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. IgG antibodies cross the placenta increasingly during pregnancy, peaking in the third trimester. No observed impacts on embryo-fetal development in monkeys at doses up to 18 times the maximum recommended human dose.

Lactation

No data on the presence of lebrikizumab in human milk, or whether the drug has effects on a breastfed infant or on milk production.

Pediatric Use

Safety and efficacy established for pediatric patients ≥12 years of age weighing ≥40 kg with moderate-to-severe atopic dermatitis.

Geriatric Use

Clinical studies did not include sufficient numbers of patients ≥65 years of age to determine if they respond differently than younger patients.

Hepatic Impairment

Lebrikizumab-lbkz does not require dosage adjustment for hepatic impairment due to minimal expected hepatic metabolism, although effects in hepatic impairment have not been studied.

Renal Impairment

No significant pharmacokinetic differences in mild or moderate renal impairment; effects in severe impairment are unknown.

Common Adverse Effects

Most common (≥1%) adverse reactions were conjunctivitis, injection site reactions, herpes zoster.

Drug Interactions

The effect of lebrikizumab-lbkz on the pharmacokinetic of co-administered medications has not been studied.

Lebrikizumab-lbkz Pharmacokinetics

Absorption

Bioavailability

86%

Plasma Concentrations

Steady-state concentrations are achieved at week 4 after administration of recommended loading doses, with dose-proportional exposure observed across doses ranging from 37.5 mg to 500 mg.

Distribution

Peak Serum Concentration

7-8 days

Special Populations

Trough concentrations were lower in patients with higher body weight.

Elimination

Half-life

24.5 days

Metabolism

Linear elimination independent of dosage.

Stability

Storage

Parenteral

Prefilled Pen or Syringe

Store in refrigerator at 2-8°C in original carton to protect from light.

Do not freeze or shake; do not microwave, expose to hot water, or leave in direct sunlight.

May store at room temperature (up to 30°C) for up to 7 days in the original carton.

Actions

Recombinant humanized IgG₄ monoclonal antibody that binds specifically to IL-13.
Blocks downstream IL-13 signaling via the IL-4Rα/IL-13Rα1 receptor complex.
Reduces IL-13 effects, such as proinflammatory cytokine, chemokine, and IgE release; does not inhibit IL-13 binding to the decoy IL-13Rα2 receptor, thus enabling IL-13 binding to IL-13Rα2 for natural clearance of IL-13.

Advice to Patients

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Provide guidance to patients and caregivers on proper sub-Q injection technique, including aseptic technique, and how to use the prefilled pen and prefilled syringe correctly. Advise patients to follow sharps disposal recommendations.
Advise patients to discontinue lebrikizumab-lbkz and to seek immediate medical attention if they experience any symptoms of systemic hypersensitivity reactions.
Advise patients to consult their healthcare provider if new onset or worsening eye symptoms develop.
Advise patients to notify their healthcare provider if they present with clinical features consistent with helminthic infection.
Advise patients that lebrikizumab-lbkz may increase the risk of infection following administration of live vaccines and that vaccination with live vaccines is not recommended during lebrikizumab-lbkz treatment. Instruct patients to inform their healthcare provider that they are taking lebrikizumab-lbkz prior to a potential vaccination.
Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Advise patients to inform their clinician if they are or plan to become pregnant or plan to breast-feed. Inform patients to report their pregnancy to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Lebrikizumab-lbkz is available through designated specialty pharmacies. Contact manufacturer or consult the lebrikizumab-lbkz website ([Web]) for specific availability information.

Lebrikizumab-lbkz
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use	250 mg/2 mL	Ebglyss (available in single-dose prefilled pens or single-dose prefilled syringes with needle shield)	Eli Lilly and Company