Dupilumab

Pronunciation: doo-PIL-ue-mab.

Generic name
dupilumab
Drug class
Interleukin-4 receptor alpha (IL-4Ra) antagonist (biologic monoclonal antibody)
Form
Injection (pre-filled syringe or pre-filled pen), 300 mg/2 mL or 200 mg/1.14 mL
Route
Subcutaneous injection
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Dupixent (5) · Full directory

What dupilumab is and how it works

Dupilumab is a prescription-only biologic (monoclonal antibody) injection used to treat several long-term conditions driven by type-2 inflammation, including certain forms of eczema, asthma, chronic sinus/nasal polyp disease, and a number of other approved uses. It works by blocking IL-4 and IL-13, two proteins that drive this type of inflammation. (1)

Take dupilumab exactly as your prescriber directs. Your specific dose, injection schedule, and starting ('loading') dose depend on which condition it is being used for and your body weight -- there is no single dose that applies to everyone.

Mechanism of action: how dupilumab works

Dupilumab is a recombinant human IgG4 monoclonal antibody that binds the IL-4 receptor alpha subunit shared by both the type I (IL-4) and type II (IL-4 and IL-13) receptor complexes, blocking IL-4- and IL-13-driven type 2 inflammatory signalling implicated across the group of approved indications. (1)

What dupilumab is used for

Atopic dermatitis (eczema)

Used for moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies, or when those therapies are not advisable, in adults and children from 6 months of age. (1) (2)

Asthma

Used as an add-on maintenance treatment for moderate-to-severe asthma with an eosinophilic phenotype, or oral-corticosteroid-dependent asthma, in people aged 6 and older. Not for relieving a sudden asthma attack. (1)

Chronic rhinosinusitis with nasal polyps (CRSwNP)

Used as an add-on maintenance treatment for adults (and adolescents in the US label) with inadequately controlled chronic sinus inflammation and nasal polyps. (1) (5)

Eosinophilic esophagitis (EoE)

Used for eosinophilic esophagitis, a chronic immune condition affecting the esophagus, in people aged 1 and older weighing at least 15 kg. (1) (4)

Prurigo nodularis

Used for prurigo nodularis, a chronic skin condition causing intensely itchy, firm nodules, in adults. (1)

Chronic obstructive pulmonary disease (COPD)

Used as an add-on maintenance treatment for COPD with an eosinophilic phenotype, in adults. (1) (3)

Chronic spontaneous urticaria (CSU)

Used for chronic spontaneous urticaria (long-term hives with no identified trigger) in people aged 2 and older who remain symptomatic despite antihistamine treatment. (1) (3)

Bullous pemphigoid

Used for bullous pemphigoid, a chronic autoimmune blistering skin disease, in adults. This is a newer US approval (2025). (1)

Allergic fungal rhinosinusitis (AFRS)

Used for allergic fungal rhinosinusitis in people aged 6 and older. This is a newer US approval (2026). (1)

Before taking dupilumab

Do not take / not appropriate for

  • Do not use dupilumab if you have had a serious allergic reaction to dupilumab or any of its ingredients. (all countries) (1) (2)

Tell your clinician about

  • Any history of eye problems, including conjunctivitis or keratitis.
  • Any parasitic (worm/helminth) infection, past or present -- this should be treated before starting dupilumab.
  • Whether you are due for any vaccinations -- live vaccines should be avoided while on dupilumab.
  • Any history of eosinophilic conditions, vasculitis, or unexplained joint pain.
  • All other medicines you take, including inhaled, topical, or oral steroids.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1) (2)

How to take dupilumab

  • Given by subcutaneous (under-the-skin) injection, usually in the thigh, abdomen (avoiding 2 inches around the navel), or upper arm.
  • Let the pre-filled syringe or pen reach room temperature before injecting -- do not warm it any other way.
  • Do not use if the solution looks cloudy, discoloured, or contains visible particles.
  • Rotate injection sites and avoid areas that are tender, bruised, red, or hard.
  • Follow your prescriber's or pharmacist's instructions on self-injection technique closely, especially the first few times.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (3) (2) (4) (5) (6)

Missed dose

Contact your prescriber or pharmacist for specific guidance if you miss a dose, since timing depends on your individual injection schedule for your particular condition.

Overdose

Seek urgent medical attention if you think you have received too much dupilumab or notice any severe or unusual symptoms after an injection. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Injection site reactions (redness, swelling, itching, or pain).

What to notice: Injection site reactions (redness, swelling, itching, or pain).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Conjunctivitis and other eye-related symptoms, including dry eye and blepharitis.

What to notice: Conjunctivitis and other eye-related symptoms, including dry eye and blepharitis.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Oral herpes (cold sores).

What to notice: Oral herpes (cold sores).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Joint pain (arthralgia).

What to notice: Joint pain (arthralgia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Raised eosinophil count on blood tests.

What to notice: Raised eosinophil count on blood tests.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Nasopharyngitis (common cold-type symptoms) and headache.

What to notice: Nasopharyngitis (common cold-type symptoms) and headache.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of a serious allergic reaction (hypersensitivity/anaphylaxis) — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash, hives, or a rash with peeling skin; fever with a rash (a sign of a rare severe skin reaction).

Action: Seek emergency medical help immediately. Your prescriber will decide whether to stop dupilumab if a significant allergic reaction occurs. (1) (2)

Signs of a rare eosinophilic condition (including EGPA-type vasculitis or eosinophilic pneumonia) — high caution

Symptoms: New or worsening rash, chest pain, breathlessness, tingling or numbness in the hands or feet, or signs of a sinus condition getting worse -- particularly if you are also reducing a corticosteroid dose.

Action: Contact your prescriber promptly if these develop; this can occur when systemic corticosteroids are being reduced under medical supervision. (1) (2)

New or worsening eye symptoms — high caution

Symptoms: Eye redness, itching, pain, or vision changes (conjunctivitis or keratitis).

Action: Report new or worsening eye symptoms to your prescriber promptly -- do not wait for your next scheduled appointment. (1) (2)

New joint symptoms — high caution

Symptoms: New or worsening joint pain, stiffness, or swelling.

Action: Tell your prescriber, who may assess for an inflammatory joint condition if symptoms persist. (1)

Interactions

  • Live and live-attenuated vaccines should be avoided while being treated with dupilumab -- discuss any planned vaccinations with your prescriber, who may advise completing them before starting treatment. (1) (2)
  • Non-live vaccines can generally still be given, but discuss timing with your prescriber. (1)
  • If you are taking corticosteroids (inhaled, topical, or oral) for your condition, your prescriber will decide whether and how to reduce these gradually -- do not change your corticosteroid dose yourself. (1) (2)
  • No specific interaction affecting how the body processes other medicines (via CYP450 enzymes) has been identified for dupilumab. (1) (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Available human data have not identified a clear drug-associated risk of birth defects or pregnancy complications. As an antibody, dupilumab is known to cross the placenta. If you have asthma, your prescriber will want to monitor your asthma control closely during pregnancy. Discuss your individual situation with your prescriber. (1) (3) (2) (4) (5) (6)

Breastfeeding

There is no data on whether dupilumab passes into breast milk or affects a breastfed infant. Antibodies like this are a normal part of human milk. Discuss the benefits and risks with your prescriber. (1) (3) (2) (4) (5) (6)

Children

Approved for certain indications from as young as 6 months (atopic dermatitis), 1 year (eosinophilic esophagitis), or 2 years (chronic spontaneous urticaria) and up, depending on the specific condition and country label -- age thresholds vary by indication and region. (1) (3) (2) (4) (5) (6)

Elderly

No specific dose adjustment based on age alone is described in the sources reviewed for this dossier. (1) (3) (2) (4) (5) (6)

Hepatic_impairment

Not specifically described as requiring dose adjustment in the sources reviewed. (1) (3) (2) (4) (5) (6)

Renal_impairment

Not specifically described as requiring dose adjustment in the sources reviewed. (1) (3) (2) (4) (5) (6)

Monitoring

Before starting

  • Screening for pre-existing helminth (parasitic worm) infection and treating it first if present
  • Review of vaccination status
  • Baseline eye examination if there is a history of eye problems

During treatment

  • Watching for new or worsening eye symptoms.
  • Watching for signs of eosinophilic conditions, especially during corticosteroid tapering.
  • Periodic clinical review of the condition being treated to confirm ongoing benefit.
(1) (2)

Storage

Refrigerate at 36-46°F (2-8°C) in the original carton to protect from light until the expiry date. Do not freeze. If needed, an individual pre-filled syringe or pen may be kept at room temperature for up to 14 days, then must be used or discarded -- do not put it back in the refrigerator after storing at room temperature. Do not use if it has been frozen, or if the solution is cloudy, discoloured, or contains visible particles.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.

United States

Indication: Multiple approved indications (atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, COPD, CSU, bullous pemphigoid, AFRS)

Dose summary: Subcutaneous injection; regimens are indication-specific. Common adult pattern: 600 mg (two 300 mg injections) initial dose then 300 mg every 2 weeks, or 400 mg initial then 200 mg every 2 weeks for select non-OCS-dependent asthma; CRSwNP uses 300 mg every 2 weeks with no loading dose; EoE uses weight-based dosing; paediatric dosing varies by age/weight and indication.

Renal context: No renal dose adjustment described in the source reviewed for this dossier. (1)

Mechanism of action

Hepatic guidance

No specific hepatic dose-adjustment guidance identified in the sources reviewed.

Overdose note

No specific antidote; manage any adverse reaction symptomatically and monitor the patient. Contact a poison control resource or emergency service as clinically indicated. (1)

Frequently asked questions

Is dupilumab (Dupixent) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, it is approved in all of these regions. In New Zealand, Medsafe classified it as a prescription medicine in 2018; separately, a 2024 media report noted Pharmac (the NZ funding agency) had funding on hold pending a local supplier -- a supply/funding question distinct from regulatory approval. (1) (3) (2) (4) (5) (6)

Why does dupilumab treat so many different conditions?

Dupilumab blocks IL-4 and IL-13, two signalling proteins involved in a group of related conditions all driven by similar 'type 2' immune inflammation -- including certain forms of eczema, asthma, sinus disease, esophagitis, chronic hives, and some autoimmune skin conditions. Each individual indication was separately studied and approved. (1)

Can I stop my inhaled or oral steroid once I start dupilumab?

No -- do not change your corticosteroid dose on your own. Your prescriber will decide if and how to reduce it gradually, since stopping abruptly can be unsafe. (1) (2)

What is the mechanism of action of dupilumab?

Dupilumab is a recombinant human IgG4 monoclonal antibody that binds the IL-4 receptor alpha subunit shared by both the type I (IL-4) and type II (IL-4 and IL-13) receptor complexes, blocking IL-4- and IL-13-driven type 2 inflammatory signalling implicated across the group of approved indications. (1)

What is the generic name of Dupilumab?

The generic name is dupilumab. (1)

What class of drug is dupilumab?

Dupilumab is classed as: Interleukin-4 receptor alpha (IL-4Ra) antagonist (biologic monoclonal antibody). (1)

References

  1. DUPIXENT (dupilumab) injection -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Sanofi-Aventis U.S. LLC / Regeneron · United States · accessed 2026-07-29 · source 1
  2. Dupixent 300 mg solution for injection in pre-filled pen -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Sanofi · United Kingdom · accessed 2026-07-29 · source 2
  3. Dupixent European Public Assessment Report (EPAR) and product informationEuropean Medicines Agency (EMA) · European Union · accessed 2026-07-29 · source 3
  4. DUPIXENT (dupilumab injection) Product MonographHealth Canada product monograph · Canada · accessed 2026-07-29 · source 4
  5. DUPIXENT dupilumab -- ARTG registration and Product InformationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 5
  6. Minutes of the Medicines Classification Committee, 7 November 2017 -- dupilumab classification decisionMedsafe Medicines Classification Committee (New Zealand regulator) · New Zealand · accessed 2026-07-29 · source 6

Brand names by country

Single-ingredient dupilumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Dupixent200 mg.14mL, 300 mg/2mL · sanofi-aventis u.s. llc

United Kingdom

  • Dupixent (2)MHRA licensed emc smpc confirmed · 300 mg, 200 mg · Sanofi

Canada

  • Dupixent (4)Health Canada approved confirmed · 300 mg, 200 mg · Sanofi-aventis Canada Inc.

Australia

  • Dupixent (5)TGA ARTG registered confirmed · 300 mg/2 mL, 300 mg (150 mg/mL) pen, 200 mg (175 mg/mL) pen · Sanofi-Aventis Australia Pty Ltd

New Zealand

  • Dupixent (6)Medsafe classified prescription medicine 2018 confirmed via classification committee minutes; Pharmac funding separately reported on hold pending NZ supplier as of a 2024 media report · not specified in fetched source · Sanofi-Aventis New Zealand Limited
View brands in additional countries.

European Union

Dupixent (3)