Dupixent
Pronunciation: DU-pix-ent
Generic name: dupilumab
Dosage form: pre-filled syringe for subcutaneous use (300 mg/2 mL and 200 mg/1.14 mL), pre-filled pen for subcutaneous use (300 mg/2 mL and 200 mg/1.14 mL)
Drug class: Interleukin inhibitors
What is Dupixent?
Dupixent is used to treat eczema, eosinophilic or oral-corticosteroid-dependent asthma, chronic rhinosinusitis with nasal polyps, COPD with an eosinophilic phenotype, eosinophilic esophagitis (EOE), chronic spontaneous urticaria, or prurigo nodularis. Dupixent injection can be self-administered subcutaneously (under the skin) every 1 to 4 weeks.
Dupixent (dupilumab) gained FDA approval on March 28, 2017, for eczema. Approvals for other medical conditions followed, based on the results of clinical trials. There is no generic or biosimilar.
How does Dupixent work?
Dupixent's mechanism of action involves targeting and blocking two key inflammatory proteins in the body, interleukin-4 (IL-4) and interleukin-13 (IL-13). These agents control inflammatory signaling pathways and substances like proinflammatory cytokines, nitric oxide, and IgE (immunoglobulin E), which contribute to inflammation in conditions that Dupixent treats, such as eczema, asthma, COPD, chronic rhinosinusitis, and EOE.
Dupixent is not an immunosuppressant. It calms overreactive immune systems, rather than fully suppressing them (see Is Dupixent an immunosuppressant?).
Dupixent belongs to the drug class called interleukin inhibitors.
FDA approvals and indications
Dupixent is approved for the following conditions:
- Eczema. Dupixent is used for eczema (atopic dermatitis) that is moderate to severe in adults and children 6 months and older whose condition is not well controlled with prescription treatments used on the skin (topical) or who cannot use topical therapies. Can be used with or without topical corticosteroids
- Asthma. In adults and children aged 6 and older, Dupixent treats moderate-to-severe eosinophilic or oral-corticosteroid-dependent asthma in conjunction with other asthma maintenance treatments. Will NOT treat an acute asthma attack or status asthmaticus (an extreme form of acute asthma)
- Chronic rhinosinusitis with nasal polyps. Dupixent is used for inadequately controlled chronic rhinosinusitis (a long-standing inflammation of the sinuses) with nasal polyps, as an add-on maintenance treatment in adults and children aged 12 years and older
- COPD. In adults, Dupixent can be used for inadequately controlled COPD with an eosinophilic phenotype as an add-on maintenance treatment
- EOE. Dupixent is also used for eosinophilic esophagitis (EOE) in adults and children 1 year of age and older who weigh at least 33 pounds (15 kg)
- Chronic spontaneous urticaria in adults and adolescents 12 years and older who remain symptomatic despite H1 antihistamine treatment
- Prurigo nodularis in adults.
Cost
The cost of Dupixent varies based on your insurance coverage, including the type of prescription drug insurance, preferred medication status, and deductible status. For cost estimates, use the Dupixent Cost and Coverage Tool.
Dupixent MyWay provides comprehensive support, including:
- Financial assistance through copay cards for eligible patients
- Help to access the medication
- Injection training and support
- Prescription delivery coordination
- Educational resources.
See Dupixent Prices, Coupons, Copay Cards & Patient Assistance for more information.
Side effects
The most common side effects of Dupixent are:
- injection site reactions (pain, swelling, burning, irritation)
- upper respiratory tract infections (stuffy nose, sneezing, sore throat)
- eye-related problems (inflammation, redness, swelling, itching, blurred vision)
- herpes virus infections and cold sores
- elevated white blood cell counts (eosinophilia)
- musculoskeletal issues (back pain, muscle/joint pain)
- respiratory symptoms (rhinitis, throat pain)
- digestive issues (diarrhea, gastritis)
- general symptoms (dizziness, insomnia, headache)
- other infections (parasitic, urinary tract)
- facial rash or redness.
Dupixent injections may hurt (see Why do Dupixent injections hurt so much?).
Note on weight gain
While not listed in the official Dupixent Package Insert, some people have reported weight gain as an anecdotal side effect (see Does Dupixent cause weight gain?).
Serious side effects and warnings
Dupixent can cause the following serious side effects:
- Allergic reactions. Dupixent can cause serious hypersensitivity reactions such as anaphylaxis, serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme. Do not use Dupixent if you are allergic to dupilumab or any of the ingredients. Seek immediate medical attention for signs of severe allergic reactions, including:
- breathing difficulties or wheezing
- rapid heartbeat
- fever
- lymph node swelling
- facial/throat swelling
- skin reactions (hives, itching, rash)
- gastrointestinal symptoms (nausea, vomiting, stomach cramps)
- fainting or dizziness
- joint pain.
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems while taking Dupixent, including eye pain, vision changes (such as blurred vision), or conjunctivitis (red or sticky eyes). Your healthcare provider may send you to an ophthalmologist for an eye exam. See Why does Dupixent cause eye problems? for more information.
- Dupixent may cause blood vessel inflammation. Tell your healthcare provider right away if you have:
- an unexplained rash
- worsening breathing difficulties
- persistent fever
- chest pain
- pins and needles sensation or numbness in your limbs.
- Joint aches and pain. Severe joint pain affecting mobility has been reported in some people who have used Dupixent. Tell your healthcare provider about any new or worsening joint symptoms.
- An increased risk of developing eosinophilic conditions. These are conditions associated with the overproduction of eosinophils, causing chronic inflammation and tissue damage. Tell your doctor if you develop a red or purple rash, shortness of breath, tingling, or nerve pain in your hands or feet.
Important safety information
Parasitic Infections
- Healthcare providers should treat confirmed or suspected parasitic infections before starting Dupixent.
- Discontinue this medication if a new infection doesn't respond to treatment.
Corticosteroid Usage
- Continue taking corticosteroids (if prescribed) as directed by your healthcare provider.
- Do not stop taking corticosteroids suddenly without your doctor's advice.
Vaccinations
- Avoid live vaccines during treatment.
- Dupixent may reduce the effectiveness of vaccines.
Asthma/COPD Management
- Not for sudden breathing problems.
- Does not replace rescue inhalers.
Age Restrictions
Dupixent's safety and effectiveness are not established for:
- Eczema/AD: children less than 6 months
- Asthma: Children less than 6 years
- Chronic rhinosinusitis with nasal polyposis: children less than 12 years
- EOE: children less than 1 year or who weigh less than 33 pounds (15 kg)
- COPD with eosinophilic phenotype: children and adolescents less than 18 years
- Chronic spontaneous urticaria: children less than 12 years
- Prurigo nodularis: children and adolescents less than 18 years.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of Dupixent. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Before taking
Do not receive if you are allergic to dupilumab, Dupixent, or any inactive ingredients in the injection.
Before using Dupixent injection, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection, such as pinworms, roundworms, or tapeworms
- are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with Dupixent
- are taking oral, topical, or inhaled corticosteroid medicines
- have asthma and use an asthma medicine, or have other medical conditions such as AD, chronic rhinosinusitis, EOE, prurigo nodularis, or chronic obstructive pulmonary disease, and also have asthma
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Do not change or stop your other medicines, including corticosteroids and asthma medicines, without talking to your healthcare provider first. This may cause symptoms controlled by these medications to come back.
Pregnancy
It is not known whether Dupixent will harm your unborn baby. Ask your healthcare provider about the risks vs benefits of using Dupixent during pregnancy.
There is a pregnancy exposure registry for women who use Dupixent during pregnancy. The purpose of this registry is to collect information about your health and that of your baby. Your healthcare provider can enroll
you in this registry or you can enroll yourself or get more information about the registry by calling 1-877-311-8972 or going to the MotherToBaby Dupixent study page.
Breastfeeding
It is not known whether Dupixent passes into your breast milk.
How do I use Dupixent?
Use exactly as prescribed by your doctor. See the detailed “Instructions for Use” that comes with the Package Insert for the Dupixent Prefilled Syringe or Dupixent Prefilled pen, including how to properly store and throw away (dispose of) used syringes and pens.
Your healthcare provider will tell you how much to inject and how often to inject it. Dupixent is only available from a specialty pharmacy that will work with you to schedule your shipments.
- Dupixent is usually administered once every 1 to 4 weeks, depending on the condition.
- It is given as an injection under the skin (subcutaneous injection).
- The pre-filled pen is only for adults and children 2 years of age and older.
- The pre-filled syringe is for adults and children 6 months of age and older.
- See How do you inject Dupixent? for more information.
Do not try to inject Dupixent until you have been shown the right way to do so by your healthcare provider.
- In children, Dupixent should be given by or under the supervision of an adult.
Your healthcare provider may prescribe other medicines to use with Dupixent. Use the other prescribed medicines exactly as your healthcare provider tells you to.
How to administer Dupixent
Dupixent is injected under the skin, usually once every 1 to 4 weeks. Your first dose may be given as 2 injections.
Before you give yourself a dose:
- Take a syringe or pen out of the refrigerator and let it reach room temperature for 30 to 45 minutes. Leave the needle cap on until you are ready to inject your dose
- Do not shake the prefilled syringe or injection pen. Prepare your injection only when you are ready to give it
- Do not use if the medicine looks cloudy, has changed colors, or has particles in it
- The Dupixent prefilled pen or syringe may be injected under the skin of your upper thigh or stomach area (except for the 2 inches [5 cm]) around your belly button (navel). Caregivers may also inject it in the outer area of your upper arm
- Choose a different site for each injection. Do not inject into skin that is tender, damaged, has bruises or scars, or into areas with visible veins. Do not inject through clothes
- Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if medicine is left over.
Dosing information
The dosage of Dupixent depends on the condition being treated and the person's age.
Eczema (Adults):
- An initial dose of Dupixent 600 mg (two 300 mg injections), followed by 300 mg every other week (Q2W).
Eczema (Child Aged 6 Months to 5 Years):
Body weight | Initial and subsequent Dupixent dosage |
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) |
Eczema (Child Aged 6 Through 17 Years):
Body weight | Initial Dupixent loading dose | Subsequent Dupixent dosage |
15 to less than 30 kg | 600 mg (two 300 mg injections) | 300 mg every 4 weeks (Q4W) |
30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
60 kg or more | 600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Asthma (Adults and Children 12 and Older)
Initial Dupixent loading dose | Subsequent Dupixent dosage |
400 mg (two 200 mg injections) | 200 mg every 2 weeks (Q2W) |
Or | |
600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Dupixent dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with comorbid chronic rhinosinusitis with nasal polyps | |
600 mg (two 300 mg injections) | 300 mg every 2 weeks (Q2W) |
Asthma (Children Aged 6 to 11 Years):
Body weight | Initial Dupixent dose and subsequent dose |
15 to less than 30 kg | 300 mg every four weeks (Q4W) |
30 kg or more | 200 mg every other week (Q2W) |
See the Dupixent Prescribing Information for Dupixent dosing for children aged 6 to 11 years with asthma and co-morbid moderate-to-severe atopic dermatitis (includes an initial loading dose).
Chronic Rhinosinusitis With Nasal Polyps (Adults and Children 12 Years and Older):
- Dupixent 300 mg given every other week (Q2W).
Eosinophilic Esophagitis (Adults and Children 1 Year and Older, at Least 15kg):
Body weight | Recommended Dupixent dosage |
15 to less than 30 kg | 200 mg every other week (Q2W) |
30 to less than 40 kg | 300 mg every other week (Q2W) |
40 kg or more | 200 mg every week (QW) |
Chronic Obstructive Pulmonary Disease (Adults):
- Dupixent 300 mg given every other week (Q2W).
Prurigo Nodularis (Adults):
- An initial dose of Dupixent 600 mg (two 300 mg injections), followed by 300 mg every other week (Q2W).
What happens if I miss a dose?
If your dose schedule is every week and you miss a dose of Dupixent, give the Dupixent injection as soon as possible and start a new every-week dose schedule from the time you remember to take your Dupixent injection.
If your dose schedule is every other week and you miss a dose of Dupixent, give the Dupixent injection within 7 days of the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, wait until the next scheduled dose to give your Dupixent injection
If your dose schedule is every 4 weeks and you miss a dose of Dupixent, give the Dupixent injection within 7 days of the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, start a new every 4-week dose schedule from the time you remember to take your Dupixent injection.
What happens if I overdose?
If you inject too much Dupixent, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What should I avoid while using this medicine?
Do not receive a "live" vaccine while using Dupixent. The vaccine may not work as well during this time and may not fully protect you from the disease. Live vaccines include MMR, typhoid, yellow fever, varicella, and zoster vaccines.
What other drugs will affect this medicine?
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you:
- are taking oral, topical, or inhaled corticosteroid medicines, have asthma, or use an asthma medicine
- are being treated for atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, or prurigo nodularis, and also have asthma.
Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicines to come back.
Dupixent has not been reported to have a drug interaction with alcohol (see Can you drink alcohol on Dupixent?).
This list is not complete. See the Dupixent Prescribing Information for a full list. Other drugs may interact with Dupixent, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Storage
Store Dupixent in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. You may store a prefilled syringe or injection pen at cool room temperature for up to 14 days. Do not store above 25°C (77°F).
Throw the injection away if not used within 14 days. Do not put it back into the refrigerator. Do not expose a Dupixent injection to heat or direct sunlight. Do NOT freeze. Do NOT shake.
Ingredients
Active ingredients: dupilumab.
Inactive ingredients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection.
Dupixent injection comes as a single-dose pre-filled syringe with a needle shield or as a pre-filled pen.
- The pre-filled syringe is available in the following strengths: 300 mg/2 mL and 200 mg/1.14 mL.
- The pre-filled pen is available in the following strengths: 300 mg/2 mL and 200 mg/1.14 mL.
What does Dupixent SOPN mean?
The abbreviation SOPN is often used with Dupixent 300 mg/2 mL as Dupixent 300 mg/2 mL SOPN. The SOPN stands for Solution Pen-Injector and means that this Dupixent injection is a prefilled pen.
What does Dupixent SOSY mean?
The abbreviation SOSY may be associated with Dupixent 300 mg/2 mL as Dupixent 300 mg/2 mL SOSY. The SOSY stands for Solution Prefilled Syringe, which means that this Dupixent injection is a prefilled syringe.
Who makes Dupixent?
Dupixent (dupilumab) is manufactured by Sanofi and Regeneron Pharmaceuticals through a collaboration agreement.
Dupixent Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Dupixent.
Dupixent (dupilumab) - Regeneron Pharmaceuticals, Inc.
Formulation type | Strength |
---|---|
Autoinjector | 200 mg/1.14 mL |
Autoinjector | 300 mg/2 mL |
Pre-Filled Syringe | 100 mg/0.67 mL Discontinued |
Pre-Filled Syringe | 200 mg/1.14 mL |
Pre-Filled Syringe | 300 mg/2 mL |
Pre-Filled Syringe | 300 mg/2 mL Discontinued |
Popular FAQ
Why do Dupixent injections hurt so much?
Dupixent (dupilumab) injections can cause discomfort for some people. The amount of discomfort people feel from injections can depend on many factors, including the temperature of the medication and individual pain tolerance. However, there are some things you can do to reduce pain and discomfort from your Dupixent injection. Continue reading
How fast does Dupixent work?
Dupixent (generic name: dupilumab) can start to work in 2 to 4 weeks to relieve symptoms associated with inflammatory conditions like eczema, asthma, and sinus swelling due to nasal polyps. Initial improvements in chronic obstructive pulmonary disease (COPD) and prurigo nodularis (a skin condition) were seen at 12 weeks. Continue reading
Why does Dupixent cause eye problems?
Dupixent is associated with several different eye problems, including conjunctivitis, blepharitis, dry eyes, itchy eyes, and keratitis. The cause of the eye problems is thought to be due to Dupixent blocking interleukin-13 (IL-13), an inflammatory protein that also stimulates the production of goblet cells. Goblet cells are responsible for creating mucus in the eye and ensuring the stability of tears. So when Dupixent blocks IL-13 it also lowers the numbers of epithelial goblet cells leading to eye inflammation and eye problems. Continue reading
How does the Dupixent Myway copay card work?
With a Dupixent MyWay copay card, you may pay as little as $0 for out-of-pocket costs if you have commercial insurance. The maximum benefit per year is $13,000. Continue reading
Is Dupixent an immunosuppressant?
No, Dupixent (dupilumab) is not an immunosuppressant or a steroid. Dupixent works by targeting a type of protein called an interleukin, that is involved in inflammation. Dupixent calms an overreactive immune system but does not suppress the immune system. This leads to fewer and less severe episodes of inflammation when used to treat conditions such as eczema, asthma, COPD, rhinosinusitis, esophagitis, and prurigo nodularis. Continue reading
Does Dupixent cause weight gain?
Yes, it does appear that Dupixent can cause weight gain, although this is not listed as a side effect in the product information. A case series of 12 people prescribed Dupixent reported an average weight gain of 6.1kg over one year – the amount of weight gained ranged from 0.1kg to 18.0kg. Anecdotally, blog sites also report weight gain as a side effect. How Dupixent causes weight gain is not known; however, people should be informed that weight gain may be a possible side effect of Dupixent. Continue reading
How effective is Dupixent for Eosinophilic Esophagitis (EOE)?
Dupixent (dupilumab) has demonstrated significant efficacy in treating eosinophilic esophagitis (EoE) across various patient populations, from children to adults. Multiple clinical trials and real-world studies have consistently shown that Dupixent substantially reduces eosinophil counts, improves endoscopic appearance, and alleviates symptoms related to difficulty swallowing. Continue reading
How long can Dupixent stay out of the fridge?
Dupixent can stay out of the fridge for a maximum of 14 days at room temperature (up to 77°F [25°C]). If you do not use it within 14 days, then it must be thrown away. Do not expose Dupixent to temperatures above 77°F and do not put it back in the refrigerator if it has been inadvertently left out and allowed to warm up to room temperature. Continue reading
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