This is our first post in a new series called “Guidelines+ Monographs”. In this series we provide an overview of a single medication or therapeutic agent, and then compare how it is positioned across all current guidelines that the medication is indicated for. This may be a single indication/guideline in some cases, or multiple indications and guidelines in others.
For our inaugural post in this Guidelines+ Monographs series, we will take a closer look at dupilumab (Dupixent) across guidelines for asthma, CRSwNP, atopic dermatitis, EoE, and more.
Note* – This Guidelines+ Monographs for dupilumab (Dupixent) is current as of May 2024. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview:
Brand name: Dupixent
Generic name: dupilumab
Manufacturer(s): Sanofi and Regeneron Pharmaceuticals
Initial FDA Approval: March 2017
Indications and FDA Approval Details
| Indicated Condition | Indicated For | Age Range | Date Approved |
| Atopic Dermatitis (AD) | Treatment of moderate to severe AD | 6 months and older | March 2017 (adults); March 2019 (adolescents); June 2022 (children); |
| Eosinophilic Esophagitis (EoE) | Treatment | 1 year and older weighing 15kg+ | May 2022 (adults); January 2024 (children) |
| Asthma | Add-on maintenance treatment for moderate to severe asthma | 6 years and older | October 2018 (adults); October 2021 (children) |
| Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) | Add-on maintenance treatment | Adults-only | June 2019 |
| Prurigo Nodularis (PN) | Treatment | Adults-only | September 2022 |
Dosage Forms and Strengths
| Dosage Form | Strength |
| Single-Dose Pre-Filled Syringe with Needle Shield | Injection: 300 mg/2 mL |
| Single-Dose Pre-Filled Syringe with Needle Shield | Injection: 200 mg/1.14 mL |
| Single-Dose Pre-Filled Pen | Injection: 300 mg/2 mL |
| Single-Dose Pre-Filled Pen | Injection: 200 mg/1.14 mL |
Dosage by Indication and Patient Population
| Indication and Details | Initial & Subsequent Dosage |
| Atopic Dermatitis | |
| Adults | initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week (Q2W) |
| Pediatric Patients 6 Months to 5 Years of Age weighing 5 to less than 15 kg | 200 mg (one 200 mg injection) every 4 weeks (Q4W) |
| Pediatric Patients 6 Months to 5 Years of Age weighing 15 to less than 30 kg | 300 mg (one 300 mg injection) every 4 weeks (Q4W) |
| Pediatric Patients 6 Years to 17 Years of Age weighing 15 to less than 30 kg | 600 mg (two 300 mg injections) + subsequent dosage of 300 mg Q4W |
| Pediatric Patients 6 Years to 17 Years of Age weighing 30 to less than 60 kg | 400 mg (two 200 mg injections) + subsequent dosage of 200 mg Q2W |
| Pediatric Patients 6 Years to 17 Years of Age weighing 60 kg or more | 600 mg (two 300 mg injections) + subsequent dosage of 300 mg Q2W |
| Asthma | |
| Most Adult and Pediatric Patients 12 Years and Older – OPTION 1 | 400 mg (two 200 mg injections) + subsequent dosage of 200 mg every 2 weeks (Q2W) |
| Most Adult and Pediatric Patients 12 Years and Older – OPTION 2 | 600 mg (two 300 mg injections) + subsequent dosage of 300 mg every 2 weeks (Q2W) |
| Patients with oral corticosteroid-dependent asthma or with comorbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyposis | 600 mg (two 300 mg injections) + subsequent dosage of 300 mg every 2 weeks (Q2W) |
| Pediatric Patients 6 to 11 Years of Age weighing 15 to less than 30 kg | 300 mg every four weeks (Q4W) |
| Pediatric Patients 6 to 11 Years of Age weighing ≥30 kg | 200 mg every other week (Q2W) |
| Chronic Rhinosinusitis with Nasal Polyposis | |
| Adults | 300 mg given every other week (Q2W). |
| Eosinophilic Esophagitis | |
| Adult and Pediatric Patients 1 Year and Older weighing 15 to less than 30 kg | 200 mg every other week (Q2W) |
| Adult and Pediatric Patients 1 Year and Older weighing 30 to less than 40 kg | 300 mg every other week (Q2W) |
| Adult and Pediatric Patients 1 Year and Older weighing 40 kg or more | 300 mg every week (QW) |
| Prurigo Nodularis | |
| Adults | initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W) |
Warnings and Precautions
- Hypersensitivity: Hypersensitivity reactions including anaphylaxis, serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme have occurred. Discontinue DUPIXENT in the event of a hypersensitivity reaction.
- Conjunctivitis and Keratitis: Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination, as appropriate.
- Eosinophilic Conditions: Be alert to vasculitic rash, worsening pulmonary symptoms, and/or neuropathy, especially upon reduction of oral corticosteroids.
- Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Decrease steroids gradually, if appropriate.
- Arthralgia: Advise patients to report new onset or worsening joint symptoms to their healthcare provider. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT.
- Parasitic (Helminth) Infections: Treat pre-existing helminth infections before initiating DUPIXENT. If patients become infected while receiving DUPIXENT and do not respond to anti-helminth treatment, discontinue DUPIXENT until the infection resolves.
- Vaccinations: Avoid use of live vaccines.
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 Polyposis (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.
Now that we’ve covered the basic monograph information for dupilumab, let’s take a closer look at how Dupixent is currently recommended in various clinical practice guidelines. We will categorize the list based on the indication, and then provide a general summary table at the end.
Dupilumab in Atopic Dermatitis Guidelines
Management of Atopic Dermatitis in Adults with Phototherapy and Systemic Therapies
Authoring Society: American Academy of Dermatology (AAD)
Publication Date: November 2023
Dupilumab-Related Recommendation(s):
For adults with moderate to severe AD, we recommend dupilumab. (Strong Recommendation, Moderate Quality of Evidence)
Atopic Dermatitis (Eczema)
Authoring Society: American College of Allergy Asthma and Immunology/American Academy of Allergy, Asthma & Immunology (ACAAI/AAAAI)
Publication Date: December 2023
Dupilumab-Related Recommendation(s):
In patients 6 months of age or older with moderate-severe AD refractory, intolerant, or unable to use mid-potency or greater topical treatment, the JTF panel recommends adding dupilumab over continued standard topical treatment without dupilumab. (Strong Recommendation, High Quality of Evidence)
Dupilumab in Asthma Guidelines
Global Strategy for Asthma Management and Prevention 2023
Authoring Society: Global Initiative for Asthma (GINA)
Publication Date: May 2023
Dupilumab-Related Recommendation(s):
Recommended as an add-on treatment for patients 6 years and older with uncontrolled severe eosinophilic / Type 2 asthma despite optimized maximal therapy, or for adults or adolescents requiring treatment with maintenance OCS (Evidence A)
Severe Asthma Management
Authoring Society: American Thoracic Society / European Respiratory Society (ATS/ERS)
Publication Date: October 2019
Dupilumab-Related Recommendation(s):
We suggest dupilumab as add-on therapy for adult patients with severe eosinophilic asthma and for those with severe corticosteroid-dependent asthma regardless of eosinophil levels. (Conditional Recommendation, Low Quality of Evidence)
Dupilumab in Chronic Rhinosinusitis with Nasal Polyps Guidelines
Medical Management of Chronic Rhinosinusitis with Nasal Polyposis
Authoring Society: American College of Allergy Asthma and Immunology/American Academy of Allergy, Asthma & Immunology (ACAAI/AAAAI)
Publication Date: November 2022
Dupilumab-Related Recommendation(s):
In people with chronic rhinosinusitis with nasal polyposis, the guideline panel suggests biologics rather than no biologics. (Conditional Recommendation, Moderate Quality of Evidence)
International Consensus Statement on Allergy and Rhinology: Rhinosinusitis 2021
Authoring Society: ICAR (AAOA/ARS)
Publication Date: November 2020
Dupilumab-Related Recommendation(s):
Dupilumab may be considered for patients with severe CRSwNP who have not improved despite other medical and surgical treatment options (Level A).
Dupilumab in Eosinophilic Esophagitis Guidelines
Management of Eosinophilic Esophagitis
Authoring Society: American Gastroenterological Association / American College of Allergy Asthma and Immunology/American Academy of Allergy, Asthma & Immunology (AGA/ACAAI/AAAAI)
Publication Date: April 2020
Dupilumab-Related Recommendation(s):
In patients with EoE, the AGA/JTF recommends using anti–IL-13 or anti–IL-4 receptor α therapy for EoE only in the context of a clinical trial. (Evidence Gap, No recommendation)
Dupilumab in Prurigo Nodularis Guidelines
No US-based society guidelines on the topic of Prurigo Nodularis exist
Summary Table Dupilumab in Clinical Guidelines
| Topic | Society | Title | Pub Date | Dupilumab Included? | Recs |
| Atopic Dermatitis | AAD | Management of Atopic Dermatitis in Adults with Phototherapy and Systemic Therapies | November 2023 | Yes | For adults with moderate to severe AD, we recommend dupilumab. (S, M) |
| Atopic Dermatitis | ACAAI/AAAAI | Atopic Dermatitis (Eczema) | December 2023 | Yes | In patients 6 months of age or older with moderate-severe AD refractory, intolerant, or unable to use mid-potency or greater topical treatment, the JTF panel recommends adding dupilumab over continued standard topical treatment without dupilumab. (S, H) |
| CRSwNP | ICAR | International Consensus Statement on Allergy and Rhinology: Rhinosinusitis 2021 | November 2020 | Yes | Dupilumab may be considered for patients with severe CRSwNP who have not improved despite other medical and surgical treatment options (Level A). |
| CRSwNP | ACAAI/AAAAI | Medical Management of Chronic Rhinosinusitis with Nasal Polyposis | November 2022 | Yes | In people with chronic rhinosinusitis with nasal polyposis, the guideline panel suggests biologics rather than no biologics. (C, M) |
| Asthma | ATS | Severe Asthma Management | October 2019 | Yes | We suggest dupilumab as add-on therapy for adult patients with severe eosinophilic asthma and for those with severe corticosteroid-dependent asthma regardless of eosinophil levels. (Conditional, Low) |
| Asthma | GINA | Global Strategy for Asthma Management and Prevention 2023 | May 2023 | Yes | Recommended as an add-on treatment for patients 6 years and older with uncontrolled severe eosinophilic / Type 2 asthma despite optimized maximal therapy, or for adults or adolescents requiring treatment with maintenance OCS (Evidence A) |
| Asthma | NHLBI | 2020 Focused Updates to the Asthma Management Guidelines | December 2020 | No | N/A |
| EoE | AGA/ACAAI/AAAAI | Management of Eosinophilic Esophagitis | April 2020 | Yes | In patients with EoE, the AGA/JTF recommends using anti–IL-13 or anti–IL-4 receptor α therapy for EoE only in the context of a clinical trial. (Evidence Gap, No recommendation) |
Looking Ahead to Future Guidelines
Looking ahead, we expect guideline updates in the next 12 months for a few of these conditions/indications. Specifically, we expect the GINA Asthma Guidelines to update in the near future. We also expect updated Eosinophilic Esophagitis later in 2024.
This concludes our Guidelines+ Monographs for Dupilumab (Dupixent). This list is current as of May 2024, and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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