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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 patients who are lactating?
There are no data on the presence of lebrikizumab in human milk, the effects on the breastfed infant, or the effects on milk production.
Information on the use of lebrikizumab during 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 immunoglobulin (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.1
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 lebrikizumab-lbkz or from the underlying maternal condition.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.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 in adolescent (aged ≥12 and <18 years, weighing ≥40 kg) patients with moderate-to-severe atopic dermatitis. Patients were randomly assigned to receive subcutaneous (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 27, 2026