Version July 2025
Dosage guidance:
Clinical considerations: Treat any preexisting helminth infections and complete all age-appropriate immunizations according to current immunization guidelines before initiating therapy; avoid administering live vaccines during therapy. Lebrikizumab may be administered in combination with or without topical corticosteroids; topical calcineurin inhibitors may be administered in combination, but reserve for sensitive areas (eg, face, neck, intertriginous areas, genital areas) only.
Atopic dermatitis, moderate to severe: SUBQ: 500 mg (given as two 250 mg injections) at week 0 and week 2, followed by 250 mg every other week until week 16 or later; once clinical response is achieved, reduce to maintenance dose of 250 mg every 4 weeks.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Lebrikizumab: Pediatric drug information")
Atopic dermatitis, moderate to severe:
Note: Treat any preexisting helminth infections and complete all age-appropriate immunizations before initiating therapy; avoid administering live vaccines during therapy. Lebrikizumab may be administered in combination with topical corticosteroids or topical calcineurin inhibitors; reserve calcineurin inhibitors for problem areas such as the face, neck, intertriginous, and genital areas.
Children ≥12 years and Adolescents, weighing ≥40 kg: SUBQ: 500 mg (two 250 mg injections) at week 0 and week 2, followed by 250 mg every other week until week 16 or later; once clinical response is achieved, reduce to maintenance dose of 250 mg every 4 weeks. Some patients have been continued on every-2-week dosing through 52 weeks (Ref). Consider discontinuation if no clinical benefit observed by week 16 (Ref).
Altered kidney function:
Children ≥12 years and Adolescents: SUBQ: No dosage adjustment necessary (Ref). Lebrikizumab is not expected to undergo significant renal elimination; no clinically significant differences in pharmacokinetics were observed in patients with mild to moderate kidney impairment.
Children ≥12 years and Adolescents: SUBQ: No dosage adjustment necessary (Ref); not expected to undergo significant hepatic elimination.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.
1% to 10%:
Immunologic: Antibody development (3%)
Local: Injection-site reaction (3%)
Ophthalmic: Conjunctivitis (10%; including allergic conjunctivitis)
<1%:
Hematologic & oncologic: Eosinophilia
Infection: Herpes zoster infection
Ophthalmic: Keratitis (including keratoconjunctivitis)
Postmarketing: Hypersensitivity: Hypersensitivity reaction (including angioedema)
Prior serious hypersensitivity to lebrikizumab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity reactions: Angioedema and urticaria have been reported. If signs/symptoms of a serious hypersensitivity reaction develop, discontinue use immediately and initiate appropriate treatment.
• Ocular effects: Conjunctivitis and keratitis have been reported; advise patients to report any new-onset or worsening eye symptoms.
Disease-related concerns:
• Helminth infections: It is unknown if administration of lebrikizumab will influence a patient's response against parasitic infections; patients with known helminth infections were not studied. Treat any preexisting helminth infections prior to initiating lebrikizumab. In patients who become infected during treatment and do not respond to antihelminth therapy, discontinue lebrikizumab until the infection resolves.
Other warnings/precautions:
• Immunizations: Complete all age-appropriate immunizations before initiating therapy; avoid administering live vaccines immediately prior to and during therapy.
• Immunogenicity: Lebrikizumab antibodies, including neutralizing antibodies, may develop.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Ebglyss: 250 mg/2 mL (2 mL)
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Ebglyss: Lebrikizumab-lbkz 250 mg/2 mL (2 mL)
No
Solution Auto-injector (Ebglyss Subcutaneous)
250 mg/2 mL (per mL): $2,100.00
Solution Prefilled Syringe (Ebglyss Subcutaneous)
250 mg/2 mL (per mL): $2,100.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Ebglyss: 250 mg/2 mL (2 mL)
Solution Prefilled Syringe, Subcutaneous:
Ebglyss: Lebrikizumab-lbkz 250 mg/2 mL (2 mL)
SUBQ: For SUBQ injection only. Remove from refrigerator and allow prefilled syringe to reach room temperature for 45 minutes prior to use; do not warm by using an external heat source (eg, hot water, microwave, direct sunlight). It is not necessary for prefilled pen to reach room temperature prior to administration. Do not shake. Administer SUBQ into the thigh, abdomen (avoiding areas within 2 inches of navel), or back of the upper arm (when administered by caregiver/health care provider). Do not administer into skin that is tender, bruised, red, hard, or affected by atopic dermatitis or skin lesions. Alternate injection site with each injection; for doses requiring >1 injection, administer at different injection sites.
If using the prefilled pen, press and hold the injection button and listen for 2 loud clicks (dose is complete after the second click, which may take up to 15 seconds). If using the prefilled syringe, slowly and steadily push plunger rod until it completely stops and the syringe is empty. Pens and syringes are for single use; discard immediately.
Note: Prefilled syringe and pen may be administered by a properly trained caregiver to pediatric patients.
SUBQ: Prefilled pen/syringe: For SUBQ injection only. Allow product to reach room temperature (45 minutes per prefilled syringe or pen); do not warm by using an external heat source (eg, hot water, microwave, direct sunlight). Do not shake. Administer SUBQ into the front of thigh (area between 2 inches below groin and 2 inches above knee), abdomen (avoiding areas within 2 inches of navel), or back of the upper arm (when administered by caregiver/health care provider). Do not administer into skin that is tender, bruised, red, hard, or affected by atopic dermatitis or skin lesions. Alternate injection site with each injection; for doses requiring >1 injection, administer at different injection sites.
Prefilled pen: Place clear base flat and firmly against skin. Press and hold the injection button and listen for 2 loud clicks (dose is complete after the second click, which may take up to 15 seconds). Pens are for single use; discard immediately after use.
Prefilled syringe: Gently pinch skin at injection site, insert needle at a 45 degree angle; slowly and steadily push plunger rod until it completely stops and the syringe is empty. Syringes are for single use; discard immediately after use.
Missed doses: If dose missed, administer as soon as possible and resume doses at regular scheduled time.
Atopic dermatitis, moderate to severe: Treatment of moderate to severe atopic dermatitis in adults and pediatric patients ≥12 years of age weighing ≥40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Vaccines (Live): Lebrikizumab may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Lebrikizumab may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Lebrikizumab is a humanized monoclonal antibody (IgG4). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Data collection to monitor pregnancy and infant outcomes following exposure to lebrikizumab is ongoing. Enroll patients exposed to lebrikizumab during pregnancy to Eli Lilly and Company (800-545-5979).
It is not known if lebrikizumab is present in breast milk.
Lebrikizumab is a humanized monoclonal antibody (IgG4). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Hypersensitivity reactions and ocular adverse effects (consider eye exam in patients with unresolved conjunctivitis).
Lebrikizumab is a human monoclonal IgG4 antibody that binds to interleukin-13 (IL-13), allowing IL-13 to bind to the IL-13Rα1 subunit but inhibits human IL-13 signaling through the IL-4Rα/IL-13Rα1 receptor complex. Lebrikizumab inhibits the bioactivity of IL-13 (a naturally occurring cytokine of the Type 2 immune response), and prevents the release of proinflammatory cytokines, chemokines, and IgE.
Distribution: Vd: 5.14 L.
Metabolism: Monoclonal antibodies are primarily degraded into small peptides and amino acids by catabolism.
Bioavailability: ~86%.
Half-life elimination: 24.5 days.
Time to peak: 7 to 8 days.
Excretion: Clearance: 0.154 L/day.
