Lebrikizumab-lbkz (Monograph)

Brand name: Ebglyss
Drug class: Immunomodulatory Agents

Medically reviewed by Drugs.com on Nov 10, 2024. Written by ASHP.

Introduction

Lebrikizumab-lbkz, an IgG4 monoclonal antibody, is an interleukin-13 antagonist.

Uses for Lebrikizumab-lbkz

Lebrikizumab-lbkz has the following uses:

Lebrikizumab-lbkz is indicated for the treatment of adults and 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. Lebrikizumab-lbkz can be used with or without topical corticosteroids.

Lebrikizumab-lbkz Dosage and Administration

General

Lebrikizumab-lbkz is available in the following dosage form(s) and strength(s):

Injection:

250 mg/2 mL in a single-dose prefilled pen
250 mg/2 mL in a single-dose prefilled syringe with needle shield

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults and Pediatric Patients ≥12 Years of Age Who Weigh ≥40 kg

Dosage and Administration

Administer by subcutaneous injection. See Full Prescribing Information for administration instructions.
Prior to treatment, complete all age-appropriate vaccinations according to current immunization guidelines.
The recommended dosage of lebrikizumab-lbkz 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 dosage is 250 mg every 4 weeks.

Cautions for Lebrikizumab-lbkz

Contraindications

Prior serious hypersensitivity to lebrikizumab-lbkz or any excipients in lebrikizumab-lbkz.

Warnings/Precautions

Hypersensitivity

Hypersensitivity reactions, including angioedema and urticaria, have been reported with use of lebrikizumab-lbkz. If a serious hypersensitivity reaction occurs, discontinue lebrikizumab-lbkz and institute appropriate therapy.

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 lebrikizumab-lbkz 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.

Advise patients to report new onset or worsening eye symptoms to their healthcare provider.

Parasitic (Helminth) Infections

Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if lebrikizumab-lbkz will influence the immune response against helminth infections by inhibiting IL-13 signaling.

Treat patients with pre-existing helminth infections before initiating treatment with lebrikizumab-lbkz. If patients become infected while receiving lebrikizumab-lbkz and do not respond to antihelminth treatment, discontinue treatment with lebrikizumab-lbkz until the infection resolves.

Vaccinations

Lebrikizumab-lbkz may alter a patient’s immunity and increase the risk of infection following administration of live vaccines. Prior to therapy with lebrikizumab-lbkz, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines immediately prior to or during treatment with lebrikizumab-lbkz. No data are available on the response to live vaccines.

Specific Populations

Pregnancy

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. Transport of human IgG antibody across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, lebrikizumab-lbkz may be transmitted from the mother to the developing fetus. 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).

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).

Lactation

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 GI 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 lebrikizumab-lbkz and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Pediatric Use

The safety and effectiveness of lebrikizumab-lbkz 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 lebrikizumab-lbkz with 270 subjects exposed to the drug for at least one year. The safety and effectiveness were generally consistent between pediatric and adult subjects.

The safety and effectiveness of lebrikizumab-lbkz have not been established in pediatric patients younger than 12 years of age and pediatric patients 12 years of age and older who weigh less than 40 kg.

Geriatric Use

Of the 1348 adult subjects with moderate-to-severe atopic dermatitis exposed to lebrikizumab-lbkz, a total of 123 were 65 years of age or older, and 29 subjects were 75 years of age or older. Clinical studies of lebrikizumab-lbkz did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

Common Adverse Effects

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

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

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.

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 subcutaneous 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 the healthcare provider that they are taking lebrikizumab-lbkz prior to a potential vaccination.
Inform patients to report their pregnancy to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

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
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