Dupilumab Injection
Dupilumab is a targeted injectable medication used to treat a range of inflammatory conditions, including moderate-to-severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, COPD, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Dupilumab Injection: Patient Information Guide
A plain-language walkthrough of Dupilumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Dupilumab injection (brand name Dupixent) is a single ingredient used across a broad range of inflammatory conditions. All uses below are for Dupixent subcutaneous injection:
- Atopic dermatitis (moderate-to-severe eczema): Adults and children 6 months and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not appropriate. Can be used with or without topical corticosteroids.
- Asthma (moderate-to-severe): Add-on maintenance treatment in adults and children 6 years and older with an eosinophilic phenotype or who depend on oral corticosteroids. Not for sudden asthma attacks.
- Chronic rhinosinusitis with nasal polyps (CRSwNP): Add-on maintenance treatment in adults and children 12 years and older with inadequately controlled disease.
- Eosinophilic esophagitis (EoE): Adults and children 1 year and older weighing at least 15 kg.
- Prurigo nodularis (PN): Adults only.
- Chronic obstructive pulmonary disease (COPD): Add-on maintenance treatment in adults with inadequately controlled COPD and an eosinophilic phenotype. Not for sudden COPD flares.
- Chronic spontaneous urticaria (CSU — ongoing hives): Adults and children 2 years and older who remain symptomatic despite antihistamine treatment. Not indicated for other types of urticaria.
- Bullous pemphigoid (a blistering skin disease): Adults only, used in combination with a tapering course of oral corticosteroids.
- Allergic fungal rhinosinusitis (AFRS): Adults and children 6 years and older who have a history of sinus surgery.
⚙️How it works▾
Dupilumab is a human monoclonal antibody — a precision-engineered protein — that blocks a receptor called IL-4Rα. This receptor is the shared gateway for two key inflammatory signals, IL-4 and IL-13. By blocking this gateway, dupilumab prevents these signals from triggering the cascade of inflammation that drives symptoms in eczema, asthma, nasal polyps, and the other conditions it treats. The result is a reduction in inflammatory chemicals, including histamine-related mediators and IgE (an antibody linked to allergic responses). The exact mechanism has not been definitively established.
💊How it's taken▾
Dupixent is given as a subcutaneous injection (under the skin) and does not need to be taken with food. The frequency varies by condition, age, and body weight — some regimens are weekly, some every 2 weeks, and some every 4 weeks. Many regimens start with a higher loading dose before settling into a regular maintenance schedule.
- Injection sites include the thigh, abdomen (avoiding 2 inches around the navel), or upper arm (if a caregiver administers it)
- Rotate injection sites with each dose to reduce irritation
- Always follow your prescriber's specific instructions — do not adjust the schedule on your own
- If you miss a dose, contact your healthcare provider for guidance rather than doubling up
🤒Side effects — in detail▾
The most common side effects vary somewhat by condition, but overall include:
- Injection site reactions (redness, swelling, itching at the shot site)
- Conjunctivitis (pink eye) and blepharitis (eyelid inflammation) — especially in atopic dermatitis
- Dry eye or eye itching
- Oral herpes or other herpes simplex infections
- Eosinophilia (higher-than-normal levels of a type of white blood cell)
- Nasopharyngitis (cold-like symptoms)
- Joint pain (arthralgia)
- Headache or dizziness (reported with some indications)
Serious reactions — including severe allergic reactions (anaphylaxis), significant eye problems, new-onset psoriasis or psoriatic arthritis, and rare lung or blood vessel conditions — should be reported to your doctor or treated as an emergency right away.
⚠️Warnings & precautions▾
- Eye problems: Conjunctivitis, keratitis (corneal inflammation), and blepharitis are among the most frequently reported concerns, especially in people with atopic dermatitis. Rare postmarketing reports include vision impairment and cases requiring surgery. Report any new or worsening eye symptoms promptly. Use with extra caution if you have dry eye disease or prior eyelid or tear duct surgery.
- Severe allergic reactions: Anaphylaxis, angioedema, and other hypersensitivity reactions have occurred. If you have trouble breathing, develop severe rash, or experience throat or face swelling, seek emergency care immediately and stop Dupixent.
- Do not stop corticosteroids suddenly: If you are on oral, inhaled, or topical steroids, do not stop them abruptly when you start Dupixent — taper slowly under your doctor's supervision to avoid withdrawal and unmasking of hidden conditions.
- Eosinophilic conditions: Particularly in asthma patients reducing oral steroids, watch for signs of serious inflammation in the lungs or blood vessels (vasculitic rash, worsening breathing, heart or kidney problems).
- New-onset psoriasis or joint pain: Tell your doctor if you notice new scaly skin patches or significant joint pain — some cases have required hospitalization or stopping Dupixent.
- Live vaccines: Avoid live vaccines during treatment. Get up-to-date on all recommended vaccines before starting Dupixent.
- Parasitic infections: Treat any existing helminth (worm) infection before starting. If a new infection develops during treatment and doesn't respond to therapy, Dupixent may need to be paused.
🔀What it interacts with▾
Dupixent has a limited number of documented interactions, but a few important ones to know:
- Live vaccines: Avoid these during Dupixent treatment — it is unknown whether the vaccine will be safe or work properly while your immune system is being modulated
- Corticosteroids (oral, inhaled, or topical): Do not abruptly stop these when starting Dupixent — dose reduction must be gradual and supervised, as stopping suddenly can cause steroid withdrawal or unmask previously hidden conditions
- Asthma medications: If you have asthma as a co-existing condition, do not adjust or stop your asthma treatments without first consulting your doctor
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to dupilumab or any Dupixent ingredient: This is a contraindication — do not take it if you've had a serious reaction before
- Eye conditions: Tell your doctor if you have dry eye disease, a history of eyelid abnormalities, or prior nasolacrimal (tear duct) surgery
- Parasitic (helminth/worm) infections: These should be treated and resolved before starting Dupixent
- Pregnancy: A pregnancy registry is available to track outcomes. Dupilumab is a large antibody that can cross the placenta, especially in the third trimester. Discuss risks and benefits with your doctor.
- Breastfeeding: It is not known whether dupilumab passes into breast milk. Discuss the potential risks and benefits with your doctor.
- Children: Dupixent is approved for various age groups depending on the condition — as young as 6 months for atopic dermatitis. Children under 12 must receive injections from a caregiver; those 12 and older should be supervised by an adult.
- Vaccinations: Complete all age-appropriate vaccines before starting treatment; avoid live vaccines during treatment
- Co-existing asthma: Tell your doctor about any asthma — do not adjust asthma medications without guidance
🚑If you take too much▾
There is no specific antidote or treatment for a Dupixent overdose. If you think you or someone else has taken too much, call Poison Control at 1-800-222-1222 right away for guidance. Monitor for any unusual symptoms and get medical attention if needed.
📡Pharmacodynamics — effects in the body▾
Dupilumab works by blocking the IL-4 and IL-13 inflammatory signaling pathways, which leads to measurable reductions in markers of inflammation throughout the body. In people with asthma, it lowers levels of eosinophil-related proteins, total IgE (an allergy-linked antibody), and exhaled nitric oxide — a marker of airway inflammation — with effects appearing as early as 2 weeks into treatment. In chronic spontaneous urticaria and allergic fungal rhinosinusitis, IgE levels decline progressively over months of treatment. Studies in adults with atopic dermatitis showed that Dupixent did not interfere with the body's ability to respond to non-live vaccines (such as Tdap and meningococcal vaccines).
🔬Pharmacokinetics — how your body processes it▾
Dupixent is injected under the skin and absorbed into the bloodstream, reaching peak levels roughly one week after a dose. Steady drug levels in the blood are typically achieved by about 16 weeks of treatment. The bioavailability (the proportion that actually reaches circulation) is approximately 61–66% across all approved conditions. Like other antibodies, dupilumab is broken down by the body's normal protein-processing pathways into small peptides and amino acids — not by the liver enzymes that process most medications. This means it is unlikely to have the liver-based drug interactions seen with many traditional medicines.
📦How to store it▾
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. store above 25°C (77°F). refrigerator, DUPIXENT must be used within 14 days or discarded.
📄 Written from Dupilumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Dupilumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Dupixent actually used for? ▾
How do I take Dupixent, and can I do it at home? ▾
What side effects should I watch out for? ▾
Can I get vaccines while I'm on Dupixent? ▾
I'm also on steroids — do I need to keep taking them? ▾
Is Dupixent safe to use during pregnancy? ▾
Is Dupilumab Injection available over the counter? ▾
When was Dupilumab Injection first available? ▾
Who makes Dupilumab Injection? ▾
💬 Answers drafted from Dupilumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Dupilumab Injection comes
Dupilumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Dupixent is used to treat moderate-to-severe atopic dermatitis in patients 6 months and older when topical prescription treatments haven't been enough
- Dupixent is used as an add-on maintenance treatment for moderate-to-severe asthma in patients 6 years and older with an eosinophilic profile or oral steroid dependence
- Dupixent is used for chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, COPD, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis in eligible patients
- Dupixent is not for relief of sudden asthma or COPD attacks, and is not for other forms of urticaria
- Dupixent is injected subcutaneously (under the skin) into the thigh, abdomen (avoiding 2 inches around the navel), or upper arm if a caregiver gives the injection
- Dupixent pre-filled pen is for patients aged 2 years and older; the pre-filled syringe is for patients aged 6 months and older
- Patients 12 years and older (or their caregivers) may self-inject after proper training from a healthcare provider; children under 12 must be injected by a caregiver
- Rotate injection sites with each dose and do not inject into skin that is tender, bruised, damaged, or scarred
📊 Dupilumab Injection across the U.S. market
How Dupilumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Dupilumab Injection is used
A general measure of how commonly Dupilumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Dupilumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Dupilumab Injection prescribed? Of the 1,596 medications we measure, Dupilumab Injection ranks #208 by Medicaid prescriptions — more than 87% of them.
Utilization by Dupilumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
2 ML dupilumab 150 MG/ML Auto-Injector Most dispensed
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2375327
2 ML dupilumab 150 MG/ML Prefilled Syringe
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1876401
1.14 ML dupilumab 175 MG/ML Auto-Injector
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2559706
1.14 ML dupilumab 175 MG/ML Prefilled Syringe
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2099300
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dupilumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 7 of 16 listed Dupilumab Injection NDCs with Medicaid activity.
🔍 Compare Dupilumab Injection products
A representative set of FDA-listed product records for Dupilumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 150 mg/mL | — | Regeneron Pharmaceuticals, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 175 mg/mL | — | Regeneron Pharmaceuticals, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg/0.67 mL | Subcutaneous | Sanofi-Aventis U.S. LLC × 4 listings | BLA | View NDC → |
| 200 mg/1.14 mL | Subcutaneous | Sanofi-Aventis U.S. LLC × 10 listings | BLA | View NDC → |
| 300 mg/2 mL | Subcutaneous | Sanofi-Aventis U.S. LLC × 10 listings | BLA | View NDC → |
Showing 26 of 26 products — FDA National Drug Code Directory. See every product, package size and price: browse all 26 Dupilumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dupilumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dupilumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Dupilumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1876376 2 dose forms · 5 strengths
-
Dose form (SCDF) Auto-Injector RxCUI 2375326In current FDA listingsClinical drug / strength (SCD) 1.14 ML dupilumab 175 MG/MLRxCUI 25597062 ML dupilumab 150 MG/MLRxCUI 2375327 -
Dose form (SCDF) Prefilled Syringe RxCUI 1876400No current FDA listingClinical drug / strength (SCD) 0.67 ML dupilumab 150 MG/MLRxCUI 25836341.14 ML dupilumab 175 MG/MLRxCUI 20993002 ML dupilumab 150 MG/MLRxCUI 1876401
Look up RxCUI 1876376 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Dupilumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. sanofi-aventis U.S. LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.