Dupilumab (Dupixent) is an interleukin-4 receptor alpha antagonist indicated for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis. Dupixent received its first United States Food and Drug Administration (FDA) approval in March 2017 making it the first biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis.
Read on to learn more about Dupixent, including its timeline of additional FDA approvals, warnings and precautions, dosage and administration information, and more.
Medication Overview:
- Brand Name: Dupixent
- Generic Name: dupilumab
- Treatment for: Atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, bullous pemphigoid, allergic fungal rhinosinusitis
- Companies: Sanofi and Regeneron
- Initial FDA Approval: March 2017
| Indicated Condition | Indication | Age | Initial Approval Date |
|---|---|---|---|
| Eczema (atopic dermatitis) | For the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids | Adult and pediatric patients 6 months and older | March 2017 |
| Asthma | As an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. | Adult and pediatric patients 6 years and older | October 2018 |
| Chronic Rhinosinusitis with Nasal Polyps | As an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). | Adult and pediatric patients 12 and older | June 2019 |
| Eosinophilic Esophagitis | For the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). | Adult and pediatric patients ages 1 and older | May 2022 |
| Prurigo Nodularis | For the treatment of adult patients with prurigo nodularis (PN). | Adults | September 2022 |
| Chronic Obstructive Pulmonary Disease | For the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. | Adults and pediatric patients 2 years and older | September 2024 |
| Chronic Spontaneous Urticaria | For the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. | Adults and pediatric patients 2 years and older | April 2025 |
| Bullous Pemphigoid | For the treatment of adult patients with bullous pemphigoid (BP). | Adults | June 2025 |
| Allergic Fungal Rhinosinusitis | For the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis who have a history of sino-nasal surgery. | Adult and pediatric patients 6 years and older | February 2026 |
Warnings and Precautions:
- Hypersensitivity: Hypersensitivity reactions including anaphylaxis, acute generalized exanthematous pustulosis (AGEP), serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme have occurred. Discontinue Dupixent in the event of a hypersensitivity reaction.
- Conjunctivitis, Keratitis, and Blepharitis: Advise patients to promptly report new onset or worsening eye symptoms to their healthcare provider. If symptoms persist or worsen, consider discontinuation of Dupixent. Consider ophthalmological examination, as appropriate.
- Eosinophilic Conditions: Be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, kidney injury and/or neuropathy, especially upon reduction of oral corticosteroids.
Dosage and Administration:
Dupixent is administered by subcutaneous injection.
Atopic Dermatitis:
- Dosage in Adults: Recommended dosage is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
- Dosage in Pediatric Patients 6 Months to 5 Years of Age: 5 to less than 15 kg: 200 mg (one 200 mg injection) every four weeks (Q4W); 15 to less than 30 kg: 300 mg (one 300 mg injection) every four weeks (Q4W). For pediatric patients 6 months to 5 years of age, no initial loading dose is recommended.
- Dosage in Pediatric Patients 6 Years to 17 Years of Age: 15 to less than 30 kg: 600 mg (two 300 mg injections), subsequent dosage 300 mg Q4W; 30 to less than 60 kg: 400 mg (two 200 mg injections), subsequent dosage 200 mg Q2W; 60 kg or more: 600 mg (two 300 mg injections), 300 mg Q2W.
Asthma:
- Dosage in Adult and Pediatric Patients 12 Years and Older: 400 mg (two 200 mg injections), subsequent dosage 200 mg every 2 weeks (Q2W); or 600 mg (two 300 mg injections), subsequent dosage 300 mg every 2 weeks (Q2W).
- Dosage for Patients with Oral Corticosteroid-Dependent Asthma or with Co-Morbid Moderate-to-Severe AD, CRSwNP, or AFRS: 600 mg (two 300 mg injections), subsequent dosage 300 mg every 2 weeks (Q2W). For pediatric patients 12 years to 17 years of age (≥60 kg) and adults with AFRS.
- Dosage in Pediatric Patients 6 Years to 11 Years of Age: 15 to less than 30 kg: 300 mg every 4 weeks (Q4W); 30 kg or more: 200 mg every 2 weeks (Q2W). For pediatric patients 6 years to 11 years of age, no initial loading dose is recommended. For pediatric patients 6 years to 11 years old with asthma and co-morbid moderate-to-severe atopic dermatitis, follow the recommended dosage as per Table 2 which include initial loading dose.
Chronic Rhinosinusitis with Nasal Polyps:
- Recommended dosage for adult and pediatric patients 12 years of age and older is 300 mg given every 2 weeks (Q2W).
Eosinophilic Esophagitis:
- Recommended Dosage in Adult and Pediatric Patients 1 Year and Older, Weighing at Least 15 kg:
- 15 to less than 30 kg: 200 mg every 2 weeks (Q2W)
- 30 to less than 40 kg: 300 mg every 2 weeks (Q2W)
- 40 kg or more: 300 mg every week (QW)
Prurigo Nodularis:
- Recommended dosage for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
Chronic Obstructive Pulmonary Disease:
- Recommended dosage for adult patients is 300 mg given every 2 weeks (Q2W).
Chronic Spontaneous Urticaria:
- Dosage in Adults: Recommended dosage is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every 2 weeks (Q2W).
- Dosage in Pediatric Patients 2 Years to 5 Years of Age: 5 to less than 15 kg: 200 mg (one 200 mg injection) every 4 weeks (Q4W); 15 to less than 30 kg: 300 mg (one 300 mg injection) every 4 weeks (Q4W). For pediatric patients 2 years to 5 years of age with CSU, no initial loading dose is recommended.
- Dosage in Pediatric Patients 6 Years to 17 Years of Age: 15 to less than 30 kg: 600 mg (two 300 mg injections), subsequent dosage 300 mg Q4W; 30 to less than 60 kg: 400 mg (two 200 mg injections), subsequent dosage 200 mg Q2W; 60 kg or more: 600 mg (two 300 mg injections), subsequent dosage 300 mg Q2W.
Bullous Pemphigoid:
- Recommended dosage for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W). Use Dupixent in combination with a tapering course of oral corticosteroids.
Allergic Fungal Rhinosinusitis:
- Dosage in Adults: Recommended dosage is 300 mg given every 2 weeks.
- Dosage in Pediatric Patients 6 Years to 17 Years of Age: 15 to less than 30 kg: 300 mg Q4W; 30 to less than 60 kg: 200 mg Q2W; 60 kg or more: 300 mg Q2W.
Contraindications:
Known hypersensitivity to dupilumab or any excipients in Dupixent.
Adverse Reactions:
Most common adverse reactions are:
- Atopic Dermatitis (incidence ≥1%): injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.
- Asthma (incidence ≥1%): injection site reactions, oropharyngeal pain, and Eosinophilia.
- Chronic Rhinosinusitis with Nasal Polyps (incidence ≥1%): injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
- Eosinophilic Esophagitis (incidence ≥2%): injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
- Prurigo Nodularis (incidence ≥2%): nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.
- Chronic Obstructive Pulmonary Disease (incidence ≥2%): viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reactions, rhinitis, eosinophilia, toothache, and gastritis.
- Chronic Spontaneous Urticaria (incidence ≥2%): injection site reactions.
- Bullous Pemphigoid (incidence ≥2%): arthralgia, conjunctivitis, vision blurred, herpes viral infections, keratitis.
- Allergic Fungal Rhinosinusitis: similar to adverse reactions for chronic rhinosinusitis with nasal polyps.
Examples of dupilumab in Guidelines
- Atopic Dermatitis (Eczema)
- American College of Allergy, Asthma, and Immunology (ACAAI), American Academy of Allergy, Asthma & Immunology (AAAAI)
- December 2023
- Medical Management of Chronic Rhinosinusitis with Nasal Polyposis
- American College of Allergy, Asthma, and Immunology (ACAA), American Academy of Allergy, Asthma & Immunology (AAAAI)
- November 2022
- Management of Eosinophilic Esophagitis
- American Gastroenterological Association (AGA), American College of Allergy, Asthma, and Immunology (ACAA), American Academy of Allergy, Asthma & Immunology (AAAAI)
- April 2020
Please note: This article is current as of August 10, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information. This post updates a previously posted Dupixent monograph published in May 2024.
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