Dupilumab 200mg/1.14ml solution for injection pre-filled syringes
Requires a prescription from a doctor or prescriber
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Safety monitoring data
Yellow Card reports
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Suspected adverse reactions reported for Dupilumab
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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.
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Suspected adverse reactions reported for Dupilumab
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Dupixent 200mg/1.14ml solution for injection pre-filled syringes
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(12)
Dupilumab for treating moderate to severe atopic dermatitis (TA534)
Dupilumab for treating severe asthma with type 2 inflammation (TA751)
Dupilumab for treating moderate to severe prurigo nodularis (TA955)
Dupilumab for maintenance treatment of uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils (TA1142)
Dupilumab for treating severe chronic rhinosinusitis with nasal polyps (TA1134)
Dupilumab for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal) (TA938)
Baricitinib for treating moderate to severe atopic dermatitis (TA681)
Mepolizumab for maintenance treatment of uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils (TA1166)
Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis (TA814)
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)
Asthma pathway (BTS, NICE, SIGN) (NG244)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Supply & safety information
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Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
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.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 33 · Randomised trials: 14 · 2015–2026
Showing the 50 most relevant studies, sorted by most relevant.
Anne‐Sofie Halling, Nikolai Loft, Jonathan I. Silverberg, et al.
Journal of the American Academy of Dermatology, 2020
- Blepharitis
- Conjunctivitis
- Dermatitis, Atopic
Ioana Agache, Jessica Beltrán, Cezmi A. Akdiş, et al.
Allergy, 2020
- Asthma
- Biological Products
- Anti-Asthmatic Agents
Emma Guttman‐Yassky, Robert Bissonnette, Benjamin Ungar, et al.
Journal of Allergy and Clinical Immunology, 2018
- Dermatitis, Atopic
- Skin
- Filaggrin Proteins
Christine E. Jo, Alexandra Finstad, Jorge R. Georgakopoulos, et al.
Journal of the American Academy of Dermatology, 2021
- Administration, Cutaneous
- Antifungal Agents
- Dermatitis, Atopic
Ioana Agache, Claudio Rocha, Jessica Beltrán, et al.
Allergy, 2020
- Asthma
- Biological Products
- Anti-Asthmatic Agents
Andrew Blauvelt, Marjolein de Bruin‐Weller, Melinda Gooderham, et al.
The Lancet, 2017
- Adrenal Cortex Hormones
- Antibodies, Monoclonal
- Dermatitis, Atopic
Amy S. Paller, Elaine C. Siegfried, Diamant Thaçi, et al.
Journal of the American Academy of Dermatology, 2020
- Administration, Topical
- Adrenal Cortex Hormones
- Dermatitis, Atopic
Amy S. Paller, Eric L. Simpson, Elaine C. Siegfried, et al.
The Lancet, 2022
- Dermatitis, Atopic
- Dermatologic Agents
- Pharmaceutical Preparations
Kristian Reich, Jacob P. Thyssen, Andrew Blauvelt, et al.
The Lancet, 2022
- Dermatitis, Atopic
- Pyrimidines
- Sulfonamides
Sally E. Wenzel, Mario Castro, Jonathan Corren, et al.
The Lancet, 2016
- Fluticasone-Salmeterol Drug Combination
- Mometasone Furoate, Formoterol Fumarate Drug Combination
- Budesonide, Formoterol Fumarate Drug Combination
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study 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
4.8 to 7 days
Mechanism
Type 2 inflammatory processes in various allergic and atopic conditions, such as…
Food interactions
None known
Human targets
3 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
600 mg
Half-life
4.8 to 7 days
[L7192]
In single-dose pharmacokinetic studies, the mean half-life of dupilumab following…
Protein binding
Volume of distribution
1.3 L
[A180478]
Metabolism
[L7192]
…
Elimination
Clearance
[L7192]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Dupilumab is commonly marketed as Dupixent, which is available as a formulation for subcutaneous injection. It was first approved by the FDA in 2017. It is currently used to treat atopic dermatitis, asthma as an add-on maintenance treatment, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.[L41900] It is used as monotherapy or in combination with other drugs, such as corticosteroids.[L7186][L7192][L41439] Dupilumab is currently under investigations for potential therapeutic use in diseases driven by allergic reactions or type 2 inflammation, such as pediatric atopic dermatitis, and chronic obstructive pulmonary disease. It is also being studied in combination with another antibody that which targets IL-33.[L7225]
Atopic Dermatitis: In the US, it is approved for patients aged six months and older with moderate-to-severe disease not adequately controlled with topical prescription therapies or when those therapies are not advisable.
[L42005]
In Europe and Canada, the drug is similarly approved for patients six months and older,[L7192][L41439] though in Europe, children aged six months to 11 years must have severe atopic dermatitis and be candidates for systemic therapy.
[L7192]
Dupilumab may be used with or without topical corticosteroids in this indication.
[L7186][L41439]
Asthma and COPD: Dupilumab is indicated as an add-on maintenance treatment for patients aged six years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma, though it is not approved for the relief of acute bronchospasm or status asthmaticus.
[L7186][L7192][L41439]
It is also indicated as an add-on maintenance treatment in adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, but again not for acute bronchospasm relief.
[L52375]
Chronic Rhinosinusitis with Nasal Polyposis: In adults with inadequately controlled CRSwNP, dupilumab is approved as an add-on maintenance treatment,[L7186] and in Canada and Europe, it is specifically used with intranasal corticosteroids.
[L7192][L41439]
Eosinophilic Esophagitis: In both the US and Europe, it is indicated for the treatment of adults and children aged one year and older weighing at least 15 kg with eosinophilic esophagitis (EoE).
[L7192][L41900][L43297]
as well as for adults with prurigo nodularis.
[L7192][L41900][L43297]
Prurigo Nodularis: In both the US and Europe, dupilumab is indication for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
[L52375][L7192]
Chronic Spontaneous Urticaria: Finally, in the US, dupilumab is indicated for adults and pediatric patients aged 12 years and older with CSU who remain symptomatic despite H1 antihistamine treatment, though it is not indicated for other forms of urticaria.
[L43297]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 393 interactions
There are two types of receptors for IL-4: the type 1 receptor, which is composed of the IL-4 chain (IL-4Rα) and a γ chain (γC), and the type 2 receptor, which is composed of the IL-4Rα chain and the α1 chain of the IL-13 receptor (IL-13Rα1).[A180709] Essentially, IL‐4Rα is a component shared by the IL‐4 and IL-13 receptor complexes [A180478] and is ubiquitously expressed on both innate and adaptive immune cells to promote the signaling of IL-4 and IL-13.[A181274] The type I receptor is primarily expressed on lymphocytes and controls Th2-cell differentiation, whereas the type II receptor is mostly found across resident and myeloid cells.[A18874] Dupilumab is a fully human monoclonal antibody directed against IL‐4Rα to inhibit the signalling of IL‐4 and IL‐13.[A180712] Dupilumab inhibits IL-4 signalling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα).[L7192] It ultimately downregulates type-2 immunity.[A180709]
While findings of some in vitro and in vivo studies suggest that some cytokine modulators may influence the expression and activity of specific cytochrome P450 (CYP450) enzymes, an open-label drug-drug interaction study demonstrated that dupilumab displays no significant effect on the activity of CYP450 enzymes studied (CYP3A, CYP2C19, CYP2C9, CYP1A2, and CYP2D6).[A180712]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L7186]
Following a subcutaneous dose, the absolute bioavailability of dupilumab ranged between 61% and 64% in patients with atopic dermatitis or asthma.
[L7192]
In clinical trials, the steady-state concentrations were reached by week 16 following the administration of 600 mg starting dose and 300 mg dose every other week. At these concentrations, the mean trough concentrations ranged from 60.3 ± 35.1 mcg/mL to 79.9 ± 41.4 mcg/mL for 300 mg dose and from 29.2 ± 18.7 to 36.5 ± 22.2 mcg/mL for 200 mg dose administered every other week.
[L7186]
[L7192]
In single-dose pharmacokinetic studies, the mean half-life of dupilumab following intravenous or subcutaneous administration ranged from 4.8 to 7 days in rats and 11.7 to 20.5 days in cynomolgus monkeys.
[L7369][L7372]
In these studies, the mean half-life was comparable was comparable following intravenous and subcutaneous administration.
[L7369]
[A180478]
[L7192]
While the metabolism of dupilumab has not been characterized, it is speculated that dupilumab undergoes nonspecific degradation into smaller peptides and amino acids, as often observed with endogenous IgG.
[A180478]
At lower concentrations, it undergoes a non-linear saturable IL-4R α target-mediated elimination.
[L7192]
[L7192]
Proteins and enzymes this drug interacts with in the body
PMID:17030238
Couples to the JAK1/2/3-STAT6 pathway. The IL4 response is involved in promoting Th2 differentiation. The IL4/IL13 responses are involved in regulating IgE production and, chemokine and mucus production at sites of allergic inflammation.
In certain cell types, can signal through activation of insulin receptor substrates, IRS1/IRS2
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
PMID:1993171 PMID:3016727
Induces the expression of class II MHC molecules on resting B-cells. Enhances both secretion and cell surface expression of IgE and IgG1 .
PMID:1993171
Also regulates the expression of the low affinity Fc receptor for IgE (CD23) on both lymphocytes and monocytes .
PMID:2521231
Positively regulates IL31RA expression in macrophages. Stimulates autophagy in dendritic cells by interfering with mTORC1 signaling and through the induction of RUFY4.
In addition, plays a critical role in higher functions of the normal brain, such as memory and learning (By similarity). Upon binding to IL4, IL4R receptor dimerizes either with the common IL2R gamma chain/IL2RG to produce the type 1 signaling complex, located mainly on hematopoietic cells, or with the IL13RA1 to produce the type 2 complex, which is also expressed on nonhematopoietic cells .
PMID:10219247 PMID:11526337 PMID:18243101
Engagement of both types of receptors initiates JAK3 and to a lower extend JAK1 phosphorylation leading to activation of the signal transducer and activator of transcription 6/STAT6 PMID:7721895
ATC D11AH05
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)
Dupilumab
Additional database identifiers
Drugs Product Database (DPD)
22918
HUGO Gene Nomenclature Committee (HGNC)
HGNC:6015
GenAtlas
IL4R
GeneCards
IL4R
GenBank Gene Database
X52425
Guide to Pharmacology
1697
UniProt Accession
IL4RA_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:5973
GenAtlas
IL13
GeneCards
IL13
GenBank Gene Database
X69079
UniProt Accession
IL13_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:6014
GenAtlas
IL4
GeneCards
IL4
GenBank Gene Database
X06750
UniProt Accession
IL4_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72