Dupilumab
Pronunciation: DU-pill-U-mab
Generic name: dupilumab
Brand name: Dupixent
Dosage form: injection for subcutaneous use
Drug class: Interleukin inhibitors
What is dupilumab?
Dupilumab (brand name Dupixent) may be used to treat eczema (atopic dermatitis [AD]), eosinophilic or oral-corticosteroid-dependent asthma, chronic rhinosinusitis with nasal polyps, COPD with an eosinophilic phenotype, eosinophilic esophagitis (EOE), or prurigo nodularis.
Dupilumab is self-administered by subcutaneous (under the skin) injection every 1 to 4 weeks.
Dupilumab first gained FDA approval under the brand name Dupixent on March 28, 2017, for eczema. Approvals for other medical conditions were based on the results of clinical trials. There is no dupilumab generic or biosimilar.
How does dupilumab work?
Dupilumab's mechanism of action involves targeting and blocking two key inflammatory proteins in your body, interleukin-4 (IL-4) and interleukin-13 (IL-13) which control inflammatory signalling pathways and substances such as proinflammatory cytokines, nitric oxide, and IgE (immunoglobulin E). This targeted approach helps control inflammation in conditions like atopic dermatitis, asthma, and other inflammatory diseases, see What is dupilumab used for and how does it work?
Dupilumab is not an immunosuppressant, it calms down an overreactive immune system, rather than fully suppressing it, relieving inflammation (see Is dupilumab an immunosuppressant?).
Dupilumab belongs to the drug class called interleukin inhibitors.
What is dupilumab used for?
Dupilumab is used to treat 6 different conditions with inflammation as a symptom. Dupilumab reduces inflammation, relieving symptoms of eczema, asthma, chronic rhinosinusitis, COPD, eosinophilic esophagitis, and prurigo nodularis. FDA approval is granted under the following criteria.
Eczema. Dupilumab 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. dupilumab for eczema can be used with or without topical corticosteroids.
Asthma. In adults and children aged 6 and older dupilumab treats moderate-to-severe eosinophilic or oral-corticosteroid-dependent asthma in addition to other asthma maintenance treatments. dupilumab will NOT treat an acute asthma attack or status asthmatics (an extreme form of acute asthma).
Chronic rhinosinusitis with nasal polyps. Dupilumab 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, dupilumab can be used for inadequately controlled COPD with an eosinophilic phenotype as an add-on maintenance treatment.
EOE. Dupilumab 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).
Prurigo nodularis in adults.
Dupilumab cost
The cost of dupilumab varies based on your insurance coverage, including 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 accessing the medication
- Injection training and support
- Prescription delivery coordination
- Educational resources.
See Dupixent (dupilumab) Prices, Coupons, Copay Cards & Patient Assistance for more cost information.
Dupilumab side effects
Common side effects of dupilumab
- 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
Dupilumab injections may hurt (see Why do Dupixent injections hurt so much?).
Note on weight gain
While not listed in the official Dupixent (dupilumab) Package Insert, some people have reported weight gain as an anecdotal side effect (see Does Dupixent cause weight gain?).
Serious side effects and warnings
Dupilumab can cause the following serious side effects.
Allergic reactions. Dupilumab can serious hypersensitivity reactions such as anaphylaxis, serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme. Do not use dupilumab 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 dupilumab, 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.
Dupilumab 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 dupilumab. Tell your healthcare provider about any new or worsening joint symptoms.
May increase the risk of developing eosinophilic conditions. These are conditions associated with 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
- Must treat existing infections before starting dupilumab
- Discontinue if new infection doesn't respond to treatment
Corticosteroid Usage
- Continue as directed by your healthcare provider
- Never stop suddenly without medical guidance
Vaccination Guidelines
- Avoid live vaccines during treatment
- May reduce vaccine effectiveness
Asthma/COPD Management
- Not for sudden breathing problems
- Does not replace rescue inhalers
Age Restrictions
Dupilumab's safety and effectiveness are not established for:
- AD/eczema: under 6 months
- Asthma: under 6 years
- Chronic rhinosinusitis with nasal polyposis: under 12 years
- EOE: under 1 year or below 33 pounds (15 kg)
- COPD with eosinophilic phenotype: under 18 years
- Prurigo nodularis: under 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 dupilumab. 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 dupilumab 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 dupilumab
- 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 corticosteroid medicine or other asthma medicine, without talking to your healthcare provider first. This may cause other symptoms that were controlled by those medicines to come back.
Pregnancy
It is not known whether dupilumab will harm your unborn baby. Ask your healthcare provider about the risks vs benefits of using dupilumab during pregnancy.
There is a pregnancy exposure registry for women who use dupilumab during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Your healthcare provider can enroll you in this registry. You may also 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 dupilumab passes into your breast milk.
How do I use dupilumab?
Use dupilumab exactly as prescribed by your doctor. See the detailed “Instructions for Use” that comes with the dupilumab Package Insert for the Dupixent (dupilumab) Prefilled Syringe or Dupixent (dupilumab) Prefilled pen including how to properly store and throw away (dispose of) used dupilumab pre-filled syringes and pre-filled pens.
Your healthcare provider will tell you how much dupilumab to inject and how often to inject it. dupilumab is only available from a speciality pharmacy that will work with you to schedule your shipments.
- Dupilumab is usually administered 1 time 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 use in adults and children 2 years of age and older.
- The pre-filled syringe is for use in adults and children 6 months of age and older.
- See How do you inject dupilumab? for more information.
If your healthcare provider decides that you or a caregiver can give the injections of dupilumab, you or your caregiver should receive training on the right way to prepare and inject dupilumab. Do not try to inject it until you have been shown the right way by your healthcare provider.
- In children 12 years of age and older, it is recommended that dupilumab be given by or under the supervision of an adult.
- In children 6 months to less than 12 years of age, dupilumab should be given by a caregiver.
Your healthcare provider may prescribe other medicines to use with this medicine. Use them exactly as your healthcare provider tells you to.
How to administer dupilumab
- Dupilumab is injected under the skin, usually 1 time every 1 to 4 weeks. Your first dose may be given in 2 injections.
- Take a syringe or pen out of the refrigerator and let it reach room temperature for 30 to 45 minutes before injecting your dose. 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 it if the medicine looks cloudy, has changed colors, or has particles inside. Call your pharmacist for new medicine.
- The 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 the 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 there is still medicine left inside.
Dupilumab dosing
The dosage of dupilumab depends on the condition being treated and the person's age.
Eczema
Dosing for eczema for adults: An initial dose of dupilumab 600 mg (two 300 mg injections), followed by 300 mg given every other week.
Dosing for eczema children 6 months to 5 years:
Body weight | Initial and subsequent dupilumab 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) |
Dosing for eczema children 6 years to 17 years:
Body weight | Initial dupilumab loading dose | Subsequent dupilumab 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
Dosing for asthma for adults and children aged 12 and older:
Initial dupilumab loading dose | Subsequent dupilumab 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) |
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) |
Dosing for asthma for children aged 6 to 11 years:
Body weight | Initial dupilumab 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 (dupilumab) Prescribing Information for dosing information 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
The recommended dosage for adults and children aged 12 and older for chronic rhinosinusitis with nasal polyps is dupilumab 300 mg given every other week (Q2W).
EoE (eosinophilic esophagitis)
Dosing for EOE for adults and children aged 1 year and older weighing at least 15kg:
Body weight | Recommended dupilumab 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) |
Prurigo nodularis
The recommended dosage for adults with prurigo nodularis is an initial dose of dupilumab 600 mg (two
300 mg injections), followed by 300 mg given every other week (Q2W).
COPD (chronic obstructive pulmonary disease)
The recommended dosage for adults with COPD is dupilumab 300 mg given every other week (Q2W).
What happens if I miss a dose?
If your dose schedule is every week and you miss a dose of dupilumab, give the dupilumab injection as soon as possible and start a new every-week dose schedule from the time you remember to take your dupilumab injection.
If your dose schedule is every other week and you miss a dose of dupilumab, give the dupilumab injection within 7 days from 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 dupilumab injection
If your dose schedule is every 4 weeks and you miss a dose of dupilumab, give the dupilumab injection within 7 days from the missed dose, then continue with your original schedule. If the missed dose is not given within 7 days, start a new 4-week dose schedule from the time you remember to take your dupilumab injection.
What happens if I overdose?
If you inject too much dupilumab, 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 dupilumab?
Do not receive a "live" vaccine while using dupilumab. The vaccine may not work as well during this time and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
What other drugs will affect dupilumab?
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 and use an asthma medicine
- have 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 medicine to come back.
Dupilumab 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 (dupilumab) Prescribing Information for a full list. Other drugs may interact, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Dupilumab storage
Store dupilumab 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 dupilumab prefilled syringe or dupilumab injection pen at cool room temperature for up to 14 days. Do not store above 25°C (77°F).
Throw dupilumab injection away if not used within 14 days. Do not put it back into the refrigerator. Do not expose a dupilumab injection to heat or direct sunlight. Do NOT freeze. Do NOT shake.
Injection ingredients
Dupilumab is only available as a Dupixent injection.
Active ingredients: dupilumab.
Inactive ingredients: L-arginine hydrochloride, L-histidine, polysorbate 80, sodium acetate, sucrose, and water for injection.
Available as a single-dose pre-filled syringe with a needle shield or as a pre-filled pen.
- The pre-filled syringe is available as Dupixent 300mg/2mL, 200mg/1.14mL, and 100mg/0.67mL.
- The pre-filled pen is available as Dupixent 300mg/2mL, and 200mg/1.14 mL.
Who makes dupilumab?
Dupixent (dupilumab) is manufactured by Sanofi and Regeneron Pharmaceuticals through a collaboration agreement.
Key drugs from Sanofi include: Lantus (diabetes), Aubagio (multiple sclerosis), and various vaccines including Fluzone (flu).
Regeneron's major drugs include: Eylea (macular degeneration), Praluent (cholesterol), and REGEN-COV (COVID-19 antibody treatment).
Dupilumab 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 dupilumab.
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 |
View Dupixent information in detail.
Popular FAQ
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
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 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
How does Dupixent work and what is its mechanism of action?
Dupixent (generic name: dupilumab) is approved to treat some people with eczema (atopic dermatitis), asthma, chronic rhinosinusitis (sinus and nasal cavity swelling) with nasal polyps (tissue growths), chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis, and prurigo nodularis (a skin condition). Dupixent works blocking proteins (IL-4, IL-13) to help lower inflammation. Continue reading
Does Dupixent cause joint pain?
Yes, it does appear that Dupixent can cause joint pain although this is not listed in the product information as a side effect. However, several reports of painful joints, tendinitis, and arthritic-like pain associated with Dupixent use have appeared recently in the literature including a 55-year-old woman with multiple joint and thumb pain, a 38-year-old with severe pain and stiffness in one ankle that progressed to her knees, hips and elbows within days of her first dose, and a 40-year-old with generalized joint pain and morning stiffness. Continue reading
Can Dupixent cure eczema?
Dupixent is not a cure for eczema; however, it does effectively reduce symptoms in the majority of people prescribed it. Dupixent significantly reduces itching, skin appearance, the frequency of eczema flares, sleep, and quality of life in most people. However, there does appear to be a subset of people who only partially respond to Dupixent (partial responders), or who respond initially, and then their symptoms return (non-durable responders). Continue reading
How do you inject Dupixent?
Dupixent (generic name: dupilumab) is given as a subcutaneous (under the skin) injection into the upper thigh or stomach area by the patient or a caregiver. A caregiver may also inject into the oyer area of the upper arm. Your doctor will tell you how often to inject Dupixent. Continue reading
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