Ebglyss

EBGLYSS 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. EBGLYSS can be used with or without topical corticosteroids.

• Prior to EBGLYSS treatment, complete all age-appropriate vaccinations according to current immunization guidelines.
• The recommended dosage of EBGLYSS 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 dose is EBGLYSS 250 mg every 4 weeks.
• Administer by subcutaneous injection.

EBGLYSS is a clear to opalescent, colorless to slightly yellow to slightly brown solution available as follows:

• Injection: 250 mg/2 mL in a single-dose prefilled pen
• Injection: 250 mg/2 mL (125 mg/mL) in a single-dose prefilled syringe with needle shield

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

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).