Dupixent (Dupilumab)
Monoclonal Antibody for Atopic Dermatitis, Asthma and Type 2 Inflammatory Conditions
Dupixent (dupilumab) is a biologic medicine that blocks two key proteins – interleukin-4 (IL-4) and interleukin-13 (IL-13) – that drive type 2 inflammation. It is used to treat moderate-to-severe atopic dermatitis, severe asthma, eosinophilic esophagitis, and chronic spontaneous urticaria. Dupixent is given as a subcutaneous injection, typically every two weeks, and has been shown to significantly improve symptoms and quality of life across these conditions.
Quick Facts
Key Takeaways
- Dupixent is the first biologic specifically approved for moderate-to-severe atopic dermatitis, offering a targeted approach that blocks the IL-4 and IL-13 pathways central to type 2 inflammation.
- It is also approved for severe asthma (as add-on maintenance therapy), eosinophilic esophagitis, and chronic spontaneous urticaria – making it a versatile treatment across multiple type 2 inflammatory diseases.
- Dupixent is administered via subcutaneous injection, typically every two weeks, and patients can self-inject at home after proper training from a healthcare professional.
- The most common side effects are injection site reactions and conjunctivitis (eye inflammation), which are generally mild to moderate and manageable.
- Dupixent is not an immunosuppressant and does not broadly suppress the immune system, which distinguishes it from many other treatments for these conditions.
What Is Dupixent and What Is It Used For?
Quick Answer: Dupixent (dupilumab) is a monoclonal antibody biologic that targets interleukin-4 (IL-4) and interleukin-13 (IL-13), two key cytokines driving type 2 inflammation. It is used to treat atopic dermatitis, severe asthma, eosinophilic esophagitis, and chronic spontaneous urticaria in adults and children.
Dupixent contains the active substance dupilumab, a fully human monoclonal antibody produced using recombinant DNA technology. Monoclonal antibodies are specialised proteins designed to precisely target specific molecules in the body. Dupilumab works by binding to the interleukin-4 receptor alpha (IL-4Rα) subunit, which is shared by both IL-4 and IL-13 receptors. By blocking this shared receptor component, dupilumab simultaneously inhibits the signalling of both IL-4 and IL-13 – two cytokines that play central roles in driving the type 2 inflammatory response underlying several chronic conditions.
Type 2 inflammation is characterised by elevated levels of specific immune markers including immunoglobulin E (IgE), eosinophils, and the cytokines IL-4, IL-5, and IL-13. This type of immune response is responsible for the skin barrier dysfunction, itching, and inflammation seen in atopic dermatitis; the airway hyperresponsiveness and mucus overproduction in certain forms of asthma; the oesophageal inflammation and fibrosis in eosinophilic esophagitis; and the hives and angioedema seen in chronic spontaneous urticaria.
Approved Indications
Atopic Dermatitis (Atopic Eczema): Dupixent is used for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older, and severe atopic dermatitis in children aged 6 months to 11 years. It can be used as monotherapy or in combination with topical treatments such as corticosteroids or calcineurin inhibitors. Clinical trials have demonstrated that Dupixent significantly improves skin clearance, reduces itching intensity by up to 50–60% within the first two weeks, and substantially improves quality of life measures including sleep quality and psychological wellbeing.
Asthma: Dupixent is approved as add-on maintenance therapy for severe asthma in adults, adolescents, and children aged 6 years and older whose asthma is inadequately controlled despite medium-to-high dose inhaled corticosteroids plus another controller medication. It is particularly effective in patients with type 2 or eosinophilic asthma, reducing severe exacerbations by approximately 50–70% and improving lung function (FEV1). In patients on oral corticosteroids, Dupixent may help reduce the need for systemic steroid use while maintaining asthma control.
Eosinophilic Esophagitis (EoE): Dupixent is indicated for the treatment of eosinophilic esophagitis in adults, adolescents, and children aged 1 year and older weighing at least 15 kg. EoE is a chronic, immune-mediated inflammatory condition of the oesophagus characterised by eosinophilic infiltration, leading to symptoms such as difficulty swallowing (dysphagia), food impaction, and chest pain. Dupixent has been shown to reduce oesophageal eosinophil counts and improve histological and symptomatic outcomes.
Chronic Spontaneous Urticaria (CSU): Dupixent is also used for adults and adolescents aged 12 years and older with moderate-to-severe chronic spontaneous urticaria that is not adequately controlled with antihistamines and who have not received immunoglobulin E (IgE) blockers for CSU. It reduces itching and hive activity, improving patients' overall quality of life.
What Should You Know Before Taking Dupixent?
Quick Answer: Do not use Dupixent if you are allergic to dupilumab or any of its excipients. Dupixent is not a rescue medication for acute asthma attacks. Inform your doctor about all medical conditions, particularly parasitic infections, eye problems, and vaccination plans before starting treatment.
Contraindications
Do not use Dupixent if you are allergic (hypersensitive) to dupilumab or any of the other ingredients in this medicine, including L-arginine monohydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sodium acetate trihydrate, acetic acid, sucrose, and water for injections. If you think you may be allergic, or if you are unsure, consult your doctor, pharmacist, or nurse before using Dupixent.
Dupixent is not an emergency or rescue medication. It must not be used to treat a sudden asthma attack or acute exacerbation. If you experience a sudden worsening of breathing, use your prescribed rescue inhaler and seek emergency medical care immediately.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before using Dupixent in the following situations:
Allergic Reactions: In rare cases, Dupixent can cause serious side effects including allergic (hypersensitivity) reactions, anaphylaxis, and angioedema. These reactions can occur from minutes to up to seven days after administration. Watch for signs such as breathing difficulties, swelling of the face, lips, mouth, throat or tongue, fainting, dizziness, feeling faint (low blood pressure), fever, general feeling of being unwell, swollen lymph nodes, hives, itching, joint pain, or skin rash. Stop using Dupixent and seek medical help immediately if you notice any of these signs.
Eosinophilic Conditions: In rare cases, patients taking asthma medications may develop inflammation of blood vessels or lungs due to an increase in certain white blood cells (eosinophils). It is not established whether Dupixent causes this. This typically occurs, but not always, in patients who are also taking corticosteroids that are being discontinued or whose dose is being reduced. Tell your doctor immediately if you develop symptoms such as flu-like illness, tingling or numbness of the arms or legs, worsening respiratory symptoms, and/or skin rash.
Parasitic Infections: Dupixent may weaken your resistance to infections caused by parasites. If you already have a parasitic (helminth) infection, it should be treated before you start Dupixent therapy. Consult your doctor if you experience diarrhoea, gas, upset stomach, greasy stools, or dehydration, as these may be signs of parasitic infection. This is particularly relevant if you live in or travel to areas where parasitic infections are common.
Asthma Patients: If you have asthma and are taking asthma medications, do not change or stop your asthma medications without talking to your doctor first. Speak with your doctor before discontinuing Dupixent or if your asthma remains uncontrolled or worsens during treatment. Corticosteroids, in particular, must be reduced gradually under medical supervision and not stopped abruptly.
Eye Problems: Talk to your doctor if you develop new or worsening eye problems, including eye pain or changes in vision. Conjunctivitis and keratitis have been reported in patients using Dupixent, particularly those with atopic dermatitis.
Drug Interactions
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is also important to tell your doctor if you have recently had or are about to have a vaccination.
The use of live and live-attenuated vaccines should be avoided during Dupixent treatment, as clinical safety and efficacy have not been established. Non-live (inactivated) vaccines, including COVID-19 vaccines, may be given during Dupixent treatment. Consult your doctor regarding your vaccination schedule.
Dupilumab is not metabolised by cytochrome P450 enzymes; however, the levels of inflammatory cytokines IL-4 and IL-13 can influence the activity of CYP450 enzymes. When starting or stopping Dupixent in patients receiving concomitant CYP450 substrates (particularly those with a narrow therapeutic index), your doctor may consider monitoring drug levels and potential dose adjustments.
| Interacting Substance | Interaction Type | Clinical Significance |
|---|---|---|
| Live vaccines | Pharmacodynamic | Avoid concurrent use; safety not established |
| CYP450 substrates (narrow therapeutic index) | Indirect (via cytokine modulation) | Monitor levels when initiating or discontinuing Dupixent |
| Oral corticosteroids | Therapeutic interaction | Taper gradually under medical supervision; do not stop abruptly |
| Topical corticosteroids | Additive benefit | Can be used concurrently; may allow dose reduction over time |
| Warfarin and other anticoagulants | Indirect (CYP450) | Consider INR monitoring when starting Dupixent |
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. The effects of Dupixent during pregnancy are not fully known. Limited human data are available, though animal studies have not shown direct harmful effects on pregnancy or fetal development. Nevertheless, Dupixent should not be used during pregnancy unless your doctor recommends it after weighing the potential benefits and risks.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using this medicine. It is not known whether dupilumab passes into human breast milk. You and your doctor should decide together whether you should breastfeed or use Dupixent; you should not attempt to do both without medical guidance. Human IgG antibodies are known to be present in breast milk, so some transfer of dupilumab is theoretically possible.
Driving and Using Machines
Dupixent is unlikely to affect your ability to drive or use machines.
Children and Adolescents
Dupixent is approved for use in various paediatric populations depending on the indication:
- Atopic dermatitis: Children aged 6 months and older (severe atopic dermatitis in children 6 months to 11 years; moderate-to-severe in adolescents 12–17 years)
- Asthma: Children aged 6 years and older
- Eosinophilic esophagitis: Children aged 1 year and older, weighing at least 15 kg
- Chronic spontaneous urticaria: Adolescents aged 12 years and older
For children under 2 years, the pre-filled pen formulation is not suitable; your doctor will prescribe the appropriate pre-filled syringe presentation. Children aged 6 months to younger than 12 years should receive Dupixent from a responsible adult. For adolescents aged 12 years and older, administration by or under the supervision of an adult is recommended.
What Is the Correct Dosage of Dupixent?
Quick Answer: Dupixent dosage varies by indication, age, and body weight. It is given as a subcutaneous injection, typically starting with a loading dose followed by maintenance injections every 1–4 weeks. Your doctor will determine the correct dose for your specific situation.
Always use Dupixent exactly as your doctor or pharmacist has told you. Do not change your dose without consulting your healthcare provider. Dupixent is administered by subcutaneous injection (injection under the skin) and your doctor or nurse will teach you the proper injection technique before you begin self-administration.
Adults – Atopic Dermatitis
Standard Adult Dosing (Atopic Dermatitis)
Loading dose: 600 mg (two 300 mg injections) on Day 1
Maintenance dose: 300 mg every two weeks
Adolescents (12–17 years) – Atopic Dermatitis
| Body Weight | Loading Dose | Maintenance Dose |
|---|---|---|
| Less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks |
Children (6–11 years) – Atopic Dermatitis
| Body Weight | Loading Dose | Maintenance Dose |
|---|---|---|
| 15 kg to less than 60 kg | 300 mg on Day 1, then 300 mg on Day 15 | 300 mg every 4 weeks* |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks |
* The dose may be increased to 200 mg every two weeks based on the physician's assessment.
Children (6 months – 5 years) – Atopic Dermatitis
| Body Weight | Loading Dose | Maintenance Dose |
|---|---|---|
| 5 kg to less than 15 kg | 200 mg (one injection) | 200 mg every 4 weeks |
| 15 kg to less than 30 kg | 300 mg (one injection) | 300 mg every 4 weeks |
Adults and Adolescents – Asthma (12 years and older)
Standard Asthma Dosing
Loading dose: 400 mg (two 200 mg injections)
Maintenance dose: 200 mg every two weeks
For patients on oral corticosteroids or with comorbid moderate-to-severe atopic dermatitis or severe chronic rhinosinusitis with nasal polyps:
Loading dose: 600 mg (two 300 mg injections)
Maintenance dose: 300 mg every two weeks
Children (6–11 years) – Asthma
| Body Weight | Dose and Frequency |
|---|---|
| 15 kg to less than 30 kg | 300 mg every 4 weeks |
| 30 kg to less than 60 kg | 200 mg every 2 weeks or 300 mg every 4 weeks |
| 60 kg or more | 200 mg every 2 weeks |
Eosinophilic Esophagitis
| Body Weight | Dose and Frequency |
|---|---|
| ≥15 to <30 kg | 200 mg every 2 weeks |
| ≥30 to <40 kg | 300 mg every 2 weeks |
| ≥40 kg | 300 mg every week |
Chronic Spontaneous Urticaria
Adults
Loading dose: 600 mg (two 300 mg injections)
Maintenance dose: 300 mg every two weeks
| Body Weight | Loading Dose | Maintenance Dose |
|---|---|---|
| 30 kg to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks |
| 60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks |
How to Inject Dupixent
Dupixent is given as an injection under the skin (subcutaneous injection). You and your doctor or nurse will decide whether you can self-inject. Before self-injecting, you must be trained by your healthcare provider. For children aged 6 months to under 12 years, a responsible adult must administer the injection. For adolescents aged 12 years and older, administration by or under the supervision of an adult is recommended.
Recommended injection sites include the front of the thighs, the abdomen (except the area 5 cm around the navel), and the outer upper arm (when someone else is giving the injection). Rotate injection sites with each dose. Do not inject into skin that is tender, damaged, bruised, or scarred. Allow the pre-filled pen to reach room temperature (below 25°C) for at least 30 minutes before injection. Do not heat the pen or expose it to direct sunlight.
Missed Dose
If you miss a dose of Dupixent, the approach depends on your dosing schedule:
- Weekly schedule: Give the injection as soon as possible and restart your weekly schedule from that point.
- Every 2 weeks schedule: Give the injection within 7 days of the missed dose, then continue your original schedule. If more than 7 days have passed, wait for your next scheduled dose.
- Every 4 weeks schedule: Give the injection within 7 days of the missed dose, then continue your original schedule. If more than 7 days have passed, restart a new every-4-weeks schedule from when you remember.
Overdose
If you use more Dupixent than prescribed or if the dose is given too early, talk to your doctor, pharmacist, or nurse. No dose-limiting toxicities have been identified in clinical trials, but medical advice should be sought for any suspected overdose.
What Are the Side Effects of Dupixent?
Quick Answer: The most common side effects of Dupixent include injection site reactions, conjunctivitis (eye inflammation), eye infections, cold sores, increased eosinophils, and joint pain. Serious but rare side effects include allergic reactions (anaphylaxis) and angioedema. Most side effects are mild to moderate.
Like all medicines, Dupixent can cause side effects, although not everybody gets them. The side effects observed in clinical trials have generally been mild to moderate in severity. Below is a breakdown of reported side effects by frequency category.
In rare cases, Dupixent may cause serious allergic (hypersensitivity) reactions including anaphylaxis, serum sickness, and serum sickness-like reactions. Signs may include breathing problems, swelling of the face, lips, mouth, throat or tongue (angioedema), fainting, dizziness, feeling faint (low blood pressure), fever, general feeling of being unwell, swollen lymph nodes, hives, itching, joint pain, or skin rash. If you experience any of these symptoms, stop using Dupixent and contact your doctor immediately or seek emergency medical care.
Common
May affect up to 1 in 10 people
- Injection site reactions (redness, swelling, itching, pain, bruising)
- Conjunctivitis (eye redness and itching)
- Eye infection
- Oral herpes (cold sores on lips and skin)
- Increased eosinophil count (a type of white blood cell)
- Joint pain (arthralgia)
Uncommon
May affect up to 1 in 100 people
- Angioedema (swelling of face, lips, mouth, throat or tongue)
- Blepharitis (itching, redness and swelling of eyelids)
- Keratitis (inflammation of the cornea), sometimes with blurred vision
- Facial rash or redness
- Dry eyes
Rare
May affect up to 1 in 1,000 people
- Serious allergic (hypersensitivity) reactions including anaphylaxis
- Ulcerative keratitis (corneal ulcers), sometimes with blurred vision
Additional Side Effects in Children
Children aged 6 to 11 years with asthma: Pinworm infection (enterobiasis) has been reported as a common side effect in this age group.
Eye-Related Side Effects
Conjunctivitis and other eye-related side effects appear to be more common in patients with atopic dermatitis using Dupixent compared to those using it for asthma. The exact mechanism is not fully understood but may relate to changes in the ocular surface immune environment when type 2 inflammation is suppressed. If you develop new or worsening eye problems, consult your doctor. Most cases of conjunctivitis are mild to moderate and can be managed with lubricating eye drops or, in more persistent cases, topical anti-inflammatory eye drops prescribed by your doctor.
Reporting Side Effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this guide. You can also report side effects directly to your national pharmacovigilance authority. By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Dupixent?
Quick Answer: Store Dupixent in a refrigerator (2°C to 8°C). Do not freeze. If needed, it can be kept at room temperature (below 25°C) for up to 14 days. Keep it in the original packaging to protect from light.
Keep this medicine out of the sight and reach of children. Do not use Dupixent after the expiry date stated on the label and carton after “EXP”. The expiry date refers to the last day of that month.
- Refrigerator storage: Store at 2°C to 8°C in the original carton to protect from light.
- Do not freeze. Do not shake the pre-filled pen. Do not heat the pen.
- Room temperature storage: If necessary, the pre-filled pen can be removed from the refrigerator and stored in its packaging at room temperature (not exceeding 25°C), protected from light, for up to 14 days. Record the date of removal from the refrigerator on the designated space on the carton.
- The pen must be discarded if it has been stored outside the refrigerator for more than 14 days, or if the expiry date has passed.
- Visual inspection: Do not use this medicine if the solution is cloudy, discoloured, or contains particles. The solution should be clear to slightly opalescent, colourless to slightly yellow. An air bubble may be visible – this is normal.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist about how to dispose of medicines no longer in use. These measures help protect the environment.
What Does Dupixent Contain?
Quick Answer: Each pre-filled pen contains 200 mg of dupilumab in 1.14 mL of solution. Excipients include L-arginine, L-histidine, polysorbate 80, sodium acetate, acetic acid, sucrose, and water for injections. The medicine contains less than 1 mmol sodium per dose and is considered “essentially sodium-free.”
Active Substance
The active substance is dupilumab. Each pre-filled pen contains 200 mg of dupilumab in 1.14 mL of solution for injection.
Excipients (Inactive Ingredients)
- L-arginine monohydrochloride
- L-histidine
- L-histidine monohydrochloride monohydrate
- Polysorbate 80 (E 433)
- Sodium acetate trihydrate
- Acetic acid (E 260)
- Sucrose
- Water for injections
This medicine contains less than 1 mmol (23 mg) sodium per 200 mg dose, meaning it is essentially sodium-free. It also contains 2.28 mg polysorbate 80 per 200 mg dose (1.14 mL). Polysorbates can cause allergic reactions in some individuals. Inform your doctor if you or your child have any known allergies to polysorbates.
Appearance and Pack Sizes
Dupixent is a clear to slightly opalescent, colourless to slightly yellow solution in a pre-filled pen. The pen may have either a round cap with an arrow-bordered oval window, or a square ridged cap with an oval window without an arrow – both types function identically. Dupixent 200 mg pre-filled pens are available in packs of 1, 2, or 6 pens, or in multipacks containing 6 pens (2 packs of 3). Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Dupixent
Dupixent (dupilumab) is used to treat moderate-to-severe atopic dermatitis (eczema), severe asthma with type 2 inflammation, eosinophilic esophagitis, and chronic spontaneous urticaria. It works by blocking two key inflammatory proteins (IL-4 and IL-13) that drive these conditions. It is available for adults and children (from 6 months of age depending on the indication) and is administered as a subcutaneous injection.
Dupixent is given as a subcutaneous injection (under the skin) using a pre-filled pen or syringe. After an initial training session with a healthcare provider, patients can self-inject at home. Common injection sites include the thigh, abdomen (avoiding the navel area), and outer upper arm (when given by someone else). Rotate injection sites each time. The injection takes up to 15 seconds to complete.
The most common side effects include injection site reactions (redness, swelling, itching, pain), conjunctivitis (eye redness and itching), eye infections, cold sores (oral herpes), increased eosinophil count, and joint pain. Most side effects are mild to moderate. Conjunctivitis is more frequently reported in patients using Dupixent for atopic dermatitis. Serious allergic reactions are rare but require immediate medical attention.
Yes. Dupixent is approved for children as young as 6 months with severe atopic dermatitis, children aged 6 years and older with severe asthma, children aged 1 year and older (weighing ≥15 kg) with eosinophilic esophagitis, and adolescents aged 12 and older with chronic spontaneous urticaria. Dosing is weight-based in children, and a responsible adult must administer injections to children under 12.
The safety of Dupixent during pregnancy has not been fully established. Limited human data are available, though animal studies have not shown harmful effects. Dupixent should only be used during pregnancy if the potential benefit justifies the potential risk. If you are pregnant, planning a pregnancy, or breastfeeding, discuss all treatment options with your doctor before starting or continuing Dupixent.
For atopic dermatitis, many patients notice improvement in itching within 1–2 weeks, with significant skin improvement by weeks 4–8. For asthma, improvement in lung function and reduction in exacerbations can be seen in the first few weeks of treatment. Full therapeutic benefit may take up to 16 weeks as the medication reaches steady-state concentrations. Treatment response varies by individual and condition.
References
- European Medicines Agency (EMA). Dupixent (dupilumab) – Summary of Product Characteristics. Updated 2025.
- U.S. Food and Drug Administration (FDA). Dupixent (dupilumab) – Prescribing Information. Regeneron Pharmaceuticals / Sanofi. 2024.
- Simpson EL, Bieber T, Guttman-Yassky E, et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. New England Journal of Medicine. 2016;375(24):2335-2348.
- Rabe KF, Nair P, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. New England Journal of Medicine. 2018;378(26):2475-2485.
- Dellon ES, Rothenberg ME, Collins MH, et al. Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis. New England Journal of Medicine. 2022;387(25):2317-2330.
- Wollenberg A, Blauvelt A, Guttman-Yassky E, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe atopic dermatitis. Journal of Allergy and Clinical Immunology. 2023;151(4):1077-1087.
- Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2023 Report.
- Wollenberg A, Kinberger M, Arents B, et al. European guideline (EuroGuiDerm) on atopic eczema. Journal of the European Academy of Dermatology and Venereology. 2022;36(8):1409-1431.
- World Health Organization (WHO). Model List of Essential Medicines. 23rd List, 2023.
- British National Formulary (BNF). Dupilumab – Drug monograph. National Institute for Health and Care Excellence (NICE). 2025.
Editorial Team
This article has been written and medically reviewed by the iMedic Medical Editorial Team, consisting of licensed specialist physicians in dermatology, allergy, immunology, and pulmonology. All content follows the GRADE evidence framework and adheres to international clinical guidelines including those from the EMA, FDA, EAACI, AAD, and GINA.
iMedic Medical Editorial Team – Specialists in Dermatology and Clinical Pharmacology
iMedic Medical Review Board – Independent panel of medical experts reviewing all content according to international guidelines
Conflict of Interest: No commercial funding. Independent medical editorial content. No pharmaceutical company sponsorship or advertising.
Evidence Level: 1A – Based on systematic reviews and meta-analyses of randomised controlled trials.