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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.
What are the effects of Ebglyss® (lebrikizumab-lbkz) on fertility?
No effects on fertility parameters were observed in sexually mature female cynomolgus monkeys, and no effects on reproductive organs or sperm analysis were observed in sexually mature male cynomolgus monkeys administered lebrikizumab-lbkz.
Effect of lebrikizumab on fertility
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 (Cavg,ss) approximately 15 times the human exposure at the maximum recommended human dose (MRHD).1
No effects on reproductive organs or sperm analysis were observed in sexually mature male cynomolgus monkeys that were administered subcutaneous (SC) doses of lebrikizumab-lbkz up to 25 mg/kg/week for 13 weeks, which was associated with plasma exposure (Cavg,ss) approximately 11 times the human exposure at the MRHD.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
The efficacy and safety of lebrikizumab has not been evaluated in human patients using concomitant contraceptive methods.
ADvocate1, ADvocate2, and ADhere clinical trial criteria
In the ADvocate1, ADvocate2, and ADhere clinical trials, women of childbearing potential were included if they
- agreed to remain abstinent by refraining from heterosexual intercourse, or
- used a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.2,3
Highly effective contraceptive methods included
- combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, and transdermal) associated with inhibition of ovulation
- progestogen-only hormonal contraception (oral, injectable, and implantable) associated with inhibition of ovulation
- intrauterine device, intrauterine hormone-releasing system
- bilateral tubal occlusion
- vasectomized partner, or
- sexual abstinence.2,3
Male patients must have agreed to use an effective barrier method of contraception during the study and for a minimum of 18 weeks following the last dose of study drug if sexually active with a female of childbearing potential.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 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