Ebglyss Drug Information

EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.

Concomitant Topical Therapies EBGLYSS can be used with or without topical corticosteroids (TCS). Topical calcineurin inhibitors (TCI) may be used, but reserved for sensitive areas only, such as the face, neck, intertriginous and genital areas.

Important Administration Instructions EBGLYSS is for subcutaneous administration. EBGLYSS is intended for use under the guidance of a healthcare professional. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of EBGLYSS.

Adult patients may self-inject, or caregivers may give EBGLYSS after training in subcutaneous injection technique. For pediatric patients, caregivers may give injections after training in subcutaneous injection technique. Sites for injection include the abdomen, thigh, and back of the upper arm.

Administration of EBGLYSS in the back of the upper arm may be performed by a caregiver or healthcare provider. Alternate the injection site with each injection. Do not inject EBGLYSS within 2 inches (5 cm) of the navel or into areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by atopic dermatitis or skin lesions.

It is not necessary to allow EBGLYSS prefilled pen or EBGLYSS prefilled syringe to warm up to room temperature before use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EBGLYSS is a clear to opalescent, colorless to slightly yellow to slightly brown solution.

Do not use if the liquid contains visible particles, is discolored or cloudy. Refer to the Instructions for Use for complete administration instructions with illustrations.

Missed Dose If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Clinical Trials Experience

Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 891 subjects were treated with EBGLYSS for at least 1 year in the atopic dermatitis development program. ADvocate 1, ADvocate 2, and KGAF compared the safety of EBGLYSS monotherapy to placebo.

ADhere compared the safety of EBGLYSS + TCS to placebo + TCS through 16 weeks. All subjects from the phase 3 trials were allowed to enroll in the long-term extension study. Eosinophilia Increased post-baseline blood eosinophils were observed at a higher frequency in EBGLYSS-treated subjects compared to placebo.

Blood eosinophil elevations were generally transient and did not result in discontinuation. The safety profile of EBGLYSS during maintenance treatment was generally consistent with the safety profile observed through Week 16. Specific Adverse Drug Reactions Conjunctivitis and Keratitis Conjunctivitis was the most frequently reported eye disorder.

Most cases of conjunctivitis and keratitis were mild or moderate in severity and recovered or resolved without treatment interruption or discontinuation. During the 16-week placebo-controlled induction period, 68 subjects reported 73 events of conjunctivitis. All events were nonserious and mild or moderate in severity.

Conjunctivitis led to treatment discontinuation in 3 subjects. During the maintenance treatment period, 14 subjects treated with EBGLYSS reported 18 events of conjunctivitis. Conjunctivitis led to treatment discontinuation in 2 subjects in the EBGLYSS 250 mg every 4 weeks group.

Keratitis led to treatment discontinuation in 2 subjects. One (0.9%) event of severe vernal keratoconjunctivitis in an EBGLYSS 250 mg every 2 weeks subject led to treatment discontinuation. Injection Site Reactions Injection site reactions were reported by 3% of the EBGLYSS group and 1% of the placebo group in the first 16 weeks of the monotherapy trials.

Incidence of injection site reactions declined with continued treatment.

Pregnancy Risk Summary 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. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations). 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) (see Data).

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 respectively.

Report pregnancies to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses and peaks during the third trimester. Therefore, EBGLYSS may be present in infants exposed in utero.

The potential clinical impact of EBGLYSS exposure in infants exposed in utero should be considered. Data Animal Data 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 (C avg,ss ) approximately 18 times the human exposure at the MRHD. Lebrikizumab-lbkz crossed the placenta in monkeys.

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 (C avg,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.

Pediatric Use The safety and effectiveness of EBGLYSS 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 EBGLYSS with 270 subjects exposed to EBGLYSS for at least one year. The safety and effectiveness were generally consistent between pediatric and adult subjects.

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

EBGLYSS is contraindicated in patients with prior serious hypersensitivity to lebrikizumab-lbkz or any excipients of EBGLYSS.

In the event of overdosage, contact Poison Control (1-800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.