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Ebglyss ™ (lebrikizumab-lbkz) injection
250 mg/2 mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Ebglyss® (lebrikizumab-lbkz) be used in pregnant patients?
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.
Use of lebrikizumab in 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.1
Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester; therefore, lebrikizumab-lbkz may be present in infants exposed in utero. The potential clinical impact of EBGLYSS exposure in infants exposed in utero should be considered.1
In animal reproduction studies, no effects on embryo-fetal development were observed after subcutaneous (SC) 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).1
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 (Cavg,ss) approximately 18 times the human exposure at the MRHD. Lebrikizumab-lbkz crossed the placenta in monkeys.1
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 (Cavg,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.1
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lebrikizumab-lbkz during pregnancy. Pregnant women exposed to lebrikizumab-lbkz are encouraged to enroll in the Ebglyss pregnancy registry by calling 1-877-311-8972 or by visiting https://pregnancyregistry.lilly.com.1
In the ADvocate1, ADvocate2, and ADhere studies, pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study were excluded. If a female patient became pregnant during the studies, they were withdrawn from study drug.2,3
Overview of ADvocate1, ADvocate2, and ADhere phase 3 studies in atopic dermatitis
The ADvocate1 (N=424) and ADvocate2 (N=427) studies were randomized, double-blind, placebo-controlled, parallel assignment, phase 3 studies designed to compare the efficacy and safety of lebrikizumab with placebo in adult and adolescent (aged ≥12 and <18 years, weighing ≥40 kg) patients with moderate-to-severe atopic dermatitis. Patients were randomly assigned to receive SC lebrikizumab every 2 weeks (loading dose of lebrikizumab 500 mg at weeks 0 and 2) or placebo for 16 weeks.2
The ADhere study (N=211) was a randomized, double-blind, placebo-controlled, parallel assignment, phase 3 study designed to compare the efficacy and safety of lebrikizumab plus topical corticosteroids (TCS) with placebo plus TCS in adult and in adolescent (aged ≥12 and <18 years, weighing ≥40 kg) patients with moderate-to-severe atopic dermatitis. Patients were randomly assigned to receive SC lebrikizumab every 2 weeks (loading dose of lebrikizumab 500 mg at weeks 0 and 2) or placebo for 16 weeks. Both groups received TCS at baseline and were tapered or stopped, as needed, based on treatment response.3
Enclosed Prescribing Information
EBGLYSS® (lebrikizumab-lbkz) injection, for subcutaneous use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Ebglyss [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Silverberg JI, Guttman-Yassky E, Thaçi D, et al. Two phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. N Engl J Med. 2023;388(12):1080-1091. https://doi.org/10.1056/NEJMoa2206714
- Simpson EL, Gooderham M, Wollenberg A, et al. Efficacy and safety of lebrikizumab in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis: a randomized clinical trial (ADhere). JAMA Dermatol. 2023;159(2):182-191. https://doi.org/10.1001/jamadermatol.2022.5534
Date of Last Review: October 21, 2026