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.

Lebrikizumab-lbkz is an IgG4 monoclonal antibody that binds with high affinity and slow off-rate to interleukin (IL)-13 and allows IL-13 to bind to IL-13Rα1 but inhibits human IL-13 signaling through the IL-4Rα/IL-13Rα1 receptor complex. IL-13 is a naturally occurring cytokine that is involved in Type 2 inflammation, which is an important component in the pathogenesis of atopic dermatitis. Lebrikizumab-lbkz inhibits IL-13-induced responses including the release of proinflammatory cytokines, chemokines and IgE. Lebrikizumab-lbkz-bound IL-13 can still bind IL-13Rα2 allowing subsequent internalization and natural clearance of IL-13.

Absorption
Following a single subcutaneous 250 mg dose of lebrikizumab-lbkz, peak serum concentrations were achieved approximately 7 to 8 days post dose. The absolute bioavailability for a subcutaneous dose was approximately 86%.

Injection site locations did not influence the absorption of lebrikizumab-lbkz.

Distribution
The lebrikizumab-lbkz steady-state volume of distribution is 5.14 L.

Metabolism/Elimination
Lebrikizumab-lbkz is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.

The lebrikizumab-lbkz half-life is 24.5 days and clearance is 0.154 L/day. Lebrikizumab-lbkz exhibits linear elimination that is independent of dose.

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

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.

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 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. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EBGLYSS and any potential adverse effects on the breastfed infant from EBGLYSS or from the underlying maternal condition.

Hypersensitivity
Conjunctivitis and Keratitis

The recommended subcutaneous dosage of EBGLYSS is an initial dose of 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later, when adequate clinical response is achieved.
The maintenance dosage of EBGLYSS is 250 mg every four weeks or 250 mg every eight weeks.

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

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.

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1. Store refrigerated at 2°C to 8°C (36°F to 46°F).
If necessary, EBGLYSS can be stored at room temperature up to 30°C (86°F) for up to 7 days in the original carton. Dispose of EBGLYSS that has been left at room temperature for longer than 7 days.

2. Store in the original carton to protect from light until use.
3. Do not freeze. Do not use EBGLYSS if it has been frozen.
4. Do not shake.
5. Do not microwave, run hot water over it, or leave it in direct sunlight.
6. Not made with natural rubber latex.