Lebrikizumab 250mg/2ml solution for injection pre-filled disposable devices
Requires a prescription from a doctor or prescriber
Safety information for pregnancy and breastfeeding
Pregnancy
The mutagenic potential of lebrikizumab has not been evaluated; however monoclonal antibodies are not expected to alter DNA or chromosomes.[L49369]
Carcinogenicity studies have not been conducted with lebrikizumab.
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Lebrikizumab
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Lebrikizumab on the MHRA register
Ebglyss 250mg/2ml solution for injection pre-filled pens
Clinical guidelines and formulary information
British National Formulary
Lebrikizumab
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(2)
Lebrikizumab for treating moderate to severe atopic dermatitis in people 12 years and over (TA986)
Nemolizumab for treating moderate to severe atopic dermatitis in people 12 years and over (TA1077)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
24.5 days
Mechanism
Lebrikizumab is an immunoglobulin (IgG4) monoclonal antibody that binds with hig…
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
250 mg
[L49369]
Following…
Half-life
24.5 days
[L49369]
Protein binding
[L49369]
Volume of distribution
5.14 L
[L49369]
Metabolism
Clearance
0.154 L
[L49369]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
On November 17, 2023, lebrikizumab was approved by the EMA under the brand name EBGLYSS for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older with a body weight of at least 40 kg. This approval is based on the positive results obtained from the Phase 3 studies ADvocate 1 and ADvocate 2, where nearly 80% of patients taking lebrikizumab either as monotherapy or combination therapy with topical corticosteroid achieved skin clearance, itch relief and reduced disease severity by week 16.[L49404] Lebrikizumab was also approved by the FDA on September 13, 2024.[L51379]
[L49369][L51374]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 379 interactions
[L49369]
The mutagenic potential of lebrikizumab has not been evaluated; however monoclonal antibodies are not expected to alter DNA or chromosomes.
[L49369]
Carcinogenicity studies have not been conducted with lebrikizumab.
Evaluation of the available evidence related to IL-13 inhibition and animal toxicology data with lebrikizumab does not suggest carcinogenic potential for lebrikizumab.
[L49369]
Single intravenous doses up to 10 mg/kg and multiple subcutaneous doses up to 500 mg have been administered to humans in clinical trials without dose-limiting toxicity. There is no specific treatment for lebrikizumab overdose. In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
[L49369]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L49369]
Following the 500 mg loading doses at week 0 and week 2, steady-state serum concentrations were achieved with the first 250 mg Q2W dose at week 4.
[L49369]
Based on a population pharmacokinetic (PK) analysis, the predicted steady-state trough concentrations (Ctrough,ss) following lebrikizumab 250 mg Q2W and Q4W subcutaneous dosing in patients with atopic dermatitis (median and 5th - 95th percentile) were 87 (46-159) µg/mL and 36 (18-68) µg/mL, respectively.
[L49369]
The absolute bioavailability was estimated at 86% based on a population PK analysis. The injection site location did not significantly influence the absorption of lebrikizumab.
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Proteins and enzymes this drug interacts with in the body
PMID:8096327 PMID:8097324
Synergizes with IL2 in regulating interferon-gamma synthesis .
PMID:8096327
Stimulates B-cell proliferation, and activation of eosinophils, basophils, and mast cells .
PMID:7903680 PMID:8759755
Plays an important role in controlling IL33 activity by modulating the production of transmembrane and soluble forms of interleukin-1 receptor-like 1/IL1RL1 (By similarity). Displays the capacity to antagonize Th1-driven proinflammatory immune response and downregulates synthesis of many proinflammatory cytokines including IL1, IL6, IL10, IL12 and TNF-alpha through a mechanism that partially involves suppression of NF-kappa-B (By similarity). Also functions on nonhematopoietic cells, including endothelial cells where it induces vascular cell adhesion protein 1/VCAM1, which is important in the recruitment of eosinophils .
PMID:8639787
Exerts its biological effects through its receptors which comprises the IL4R chain and the IL13RA1 chain, to activate JAK1 and TYK2, leading to the activation of STAT6 .
PMID:9013879
Aside from IL13RA1, another receptor IL13RA2 acts as a high affinity decoy for IL13 and mediates internalization and depletion of extracellular IL13 PMID:21622864
ATC D11AH10
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Lebrikizumab
DrugBank citations
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