Dupilumab
Pronunciation: DU-pill-U-mab
Generic name: dupilumab
Brand name: Dupixent
Dosage form: single-dose prefilled syringe (200 mg/1.14 mL, 300 mg/2 mL), single-dose prefilled pen (200 mg/1.14 mL, 300 mg/2 mL)
Drug class: Interleukin inhibitors
What is dupilumab?
Dupilumab 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. All these conditions have inflammation in common.
Dupilumab is a subcutaneous injection that can be self-administered using a prefilled syringe or pen every 1 to 4 weeks, depending on the condition. The brand name is Dupixent.
Dupilumab first gained FDA approval on March 28, 2017, under the brand Dupixent, made by Sanofi and Regeneron Pharmaceuticals under a collaborative agreement. There is no generic or biosimilar.
How does dupilumab work?
Dupilumab targets and blocks 2 key inflammatory proteins in your body, interleukin-4 (IL-4) and interleukin-13 (IL-13). Il-4 and IL-3 control inflammatory signalling pathways and substances such as proinflammatory cytokines, nitric oxide, and IgE (immunoglobulin E). Blocking IL-4 and IL-13 helps control inflammation in conditions such as atopic dermatitis, asthma, urticaria, COPD, and other inflammatory diseases.
Dupilumab does not fully suppress the immune system, rather it calms it down, relieving inflammation.
Dupilumab belongs to the drug class called interleukin inhibitors.
FDA-approved uses and indications
Dupilumab is approved by the FDA for:
- moderate-to-severe atopic dermatitis (eczema) in adults and children 6 months and older whose disease is not adequately controlled with topical prescription treatments or who cannot use these treatments. May be used with or without topical corticosteroids
- moderate-to-severe Asthma characterized by an eosinophilic phenotype or that is oral corticosteroid dependent in adults and children 6 years and older. Not for the relief of an acute asthma attack (acute bronchospasm) or status asthmatics (an extreme form of acute asthma)
- inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP), as an add-on maintenance treatment in adults and children 12 years and older
- eosinophilic esophagitis (EoE) in adults and children 1 year of age and older, who weigh at least 33 pounds (15 kg)
- Prurigo nodularis (PN) in adults
- inadequately controlled COPD with an eosinophilic phenotype as add-on maintenance treatment in adults. Not for the relief of acute bronchospasm
- Chronic spontaneous urticaria in adults and adolescents 12 years and older who remain symptomatic despite H1 antihistamine treatment.
Side effects
The most common side effects of dupilumab are:
- injection site reactions, such as pain, swelling, or burning at the injection site
- upper respiratory tract infections, such as a cold or the flu
- eye-related problems with eye symptoms such as inflammation, redness, swelling, itching, or blurred vision
- herpes virus infections and cold sores
- elevated white blood cell counts
- musculoskeletal issues (back pain, muscle/joint pain)
- respiratory symptoms (rhinitis, throat pain)
- digestive issues (diarrhea, gastritis)
- dizziness, sleeplessness, or headache
- other infections, such as parasitic infections or urinary tract infections
- facial rashes or redness.
Serious side effects and warnings
Dupilumab can cause the following serious side effects.
- Allergic reactions. Dupilumab can cause 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.
- 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.
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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Important safety information
Parasitic Infections
- Must treat existing infections before starting dupilumab.
- Discontinue if a 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
- CRwNP: under 12 years
- EOE: under 1 year or below 33 pounds (15 kg)
- COPD with eosinophilic phenotype: under 18 years
- Chronic urticaria: under 12 years
- Prurigo nodularis: under 18 years
Before taking
Do not receive dupilumab 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 enrol you in this registry. You may also enrol 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 come with the Package Insert.
- Your healthcare provider will tell you how much dupilumab to inject and how often to inject it. Dupilumab is only available from a specialty 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 for adults and children 2 years and older.
- The pre-filled syringe is for adults and children 6 months and older.
A caregiver or patient 12 years of age and older may inject dupilumab using the pre-filled syringe or pre-filled pen.
- In children 12 to 17 years of age, administer under the supervision of an adult.
- In children 6 months to less than 12 years of age, administer dupilumab 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 a 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 medicine is left inside.
Dosing information
The dosage of dupilumab depends on the condition being treated and the person's age.
Eczema
Adults: An initial dose of dupilumab 600 mg (two 300 mg injections), followed by 300 mg given every other week.
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) |
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
Adults and children 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) |
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
Adults and children aged 12 and older: dupilumab 300 mg given every other week (Q2W).
EoE (eosinophilic esophagitis)
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
Adults: an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W).
COPD (chronic obstructive pulmonary disease)
Adults: 300 mg given every other week (Q2W).
Chronic Spontaneous Urticaria
Adults: an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week (Q2W).
Children 12 through 17 years:
Body weight | Initial Loading Dose | Subsequent Dosage |
30 to less than 60 kg | 400 mg (two 200 mg injections) | 200 mg Q2W |
60 kg or more | 600 mg (two 300 mg injections) | 300 mg Q2W |
Dupilumab cost
The cost of dupilumab 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 (dupilumab) Prices, Coupons, Copay Cards & Patient Assistance for more cost information.
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 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 dupilumab injection
If your dose schedule is every 4 weeks and you miss a dose of dupilumab, give the dupilumab 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 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 this medicine?
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 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, 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 medicines 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.
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 prefilled syringe or injection pen at cool room temperature for up to 14 days. Do not store above 25°C (77°F).
Throw the 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.
Ingredients
Dupilumab is only available as the brand name Dupixent.
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 300 mg/2 mL and 200 mg/1.14 mL.
- The pre-filled pen is available as 300 mg/2 mL and 200 mg/1.14 mL.
Who makes dupilumab?
Dupilumab is manufactured by Sanofi and Regeneron Pharmaceuticals through a collaborative agreement, under the brand Dupixent. Sanofi is headquartered in Paris, France, and Regeneron Pharmaceuticals are headquartered in Tarrytown, New York, USA.
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
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
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
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