Package leaflet: Dupixent 300 mg solution for injection in pre-filled syringe

1. What Dupixent is and what it is used for

What Dupixent is
Dupixent contains the active substance dupilumab.

Dupilumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called interleukins (IL)-4 and IL-13. Both play a major role in causing the signs and symptoms of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis (PN), eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria (CSU).

What Dupixent is used for
Dupixent is used to treat adults and adolescents 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema. Dupixent is also used to treat children 6 months to 11 years old with severe atopic dermatitis. Dupixent may be used with eczema medicines that you apply to the skin or it may be used on its own.

Dupixent is also used with other asthma medicines for the maintenance treatment of severe asthma in adults, adolescents, and children aged 6 years and older whose asthma is not controlled with their current asthma medicines (e.g. corticosteroids).

Dupixent is also used with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled with their current CRSwNP medicines. Dupixent can also reduce the need for surgery and the need for systemic corticosteroid use.

Dupixent is also used to treat adults with moderate-to-severe prurigo nodularis (PN), also known as chronic nodular prurigo (CNPG). Dupixent may be used with PN medicines that you apply to the skin or it may be used on its own.

Dupixent is also used to treat adults, adolescents and children 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).

Dupixent is also used with other medicines for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults with uncontrolled COPD.

Dupixent is also used to treat adults, adolescents, and children 2 years and older with moderate-to- severe chronic spontaneous urticaria (CSU) not controlled with antihistamines who have not received immunoglobulin E (IgE) blockers for their CSU.

How Dupixent works
Using Dupixent for atopic dermatitis (atopic eczema) can improve the condition of your skin and reduce itching. Dupixent has also been shown to improve symptoms of pain, anxiety, and depression associated with atopic dermatitis. In addition, Dupixent helps improve your sleep disturbance and overall quality of life.

Dupixent helps prevent severe asthma attacks (exacerbations) and can improve your breathing.
Dupixent may also help reduce the amount of another group of medicines you need to control your asthma, called oral corticosteroids, while preventing severe asthma attacks and improving your breathing.

Dupixent helps prevent moderate or severe COPD attacks (exacerbations) and can improve your breathing. Dupixent may also help to improve overall symptoms of COPD.

Using Dupixent for CSU can improve the condition of your skin by reducing itch and hives.

2. What you need to know before you use Dupixent

Do not use Dupixent
- if you are allergic to dupilumab or any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using Dupixent.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Dupixent:

Dupixent is not a rescue medicine and should not be used to treat a sudden asthma or COPD attack.

Every time you get a new pack of Dupixent, it is important that you note down the name of the medicine, the date of the administration and the batch number (which is on the packaging after “Lot”) and keep this information in a safe place.

Allergic reactions
- Rarely, Dupixent can cause serious side effects, including allergic (hypersensitivity) reactions and anaphylactic reaction and angioedema. These reactions can occur from minutes until seven days after Dupixent administration. You must look out for signs of these conditions (i.e. breathing problems, swelling of the face, lips, mouth, throat or tongue, fainting, dizziness, feeling lightheaded (low blood pressure), fever, general ill feeling, swollen lymph nodes, hives, itching, joint pain, skin rash) while you are taking Dupixent. Such signs are listed under “Serious side effects” in section 4.
- Stop using Dupixent and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction.

Eosinophilic conditions

Rarely patients taking an asthma medicine may develop inflammation of blood vessels or lungs due to an increase of certain white blood cells (eosinophilia).
It is not known whether this is caused by Dupixent. This usually, but not always, happens in people who also take a steroid medicine which is being stopped or for which the dose is being lowered.
Tell your doctor immediately if you develop a combination of symptoms such as a flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash.

Parasitic (intestinal parasites) infection
- Dupixent may weaken your resistance to infections caused by parasites. If you already have a parasitic infection it should be treated before you start treatment with Dupixent.
- Check with your doctor if you have diarrhoea, gas, upset stomach, greasy stools, and dehydration which could be a sign of a parasitic infection.
- If you live in a region where these infections are common or if you are travelling to such a region check with your doctor.

Asthma
If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your doctor. Talk to your doctor before you stop Dupixent or if your asthma remains uncontrolled or worsens during treatment with this medicine.

Eye problems
Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision.

Children and adolescents
- The safety and benefits of Dupixent are not yet known in children with atopic dermatitis below the age of 6 months.
- The safety and benefits of Dupixent are not yet known in children with asthma below the age of 6 years.
- The safety and benefits of Dupixent are not yet known in children with CRSwNP below the age of 18 years.
- The safety and benefits of Dupixent are not known in children with PN below the age of 18 years.
- The safety and benefits of Dupixent are not yet known in children with EoE below the age of 1 year, or with a body weight < 15 kg.
- The safety and benefits of Dupixent are not known in children with COPD below the age of 18 years.
- The safety and benefits of Dupixent are not yet known in children with CSU below the age of 2 years.

Other medicines and Dupixent
Tell your doctor or pharmacist
- if you are using, have recently used or might use any other medicines.
- if you have recently had or are due to have a vaccination.

Other medicines for asthma
Do not stop or reduce your asthma medicines, unless instructed by your doctor.
- These medicines (especially ones called corticosteroids) must be stopped gradually.
- This must be done under the direct supervision of your doctor and dependent on your response to Dupixent.

Pregnancy and breast-feeding

- If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. The effects of this medicine in pregnant women are not known;
therefore, it is preferable to avoid the use of Dupixent in pregnancy unless your doctor advises to use it.
- If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you will breast-feed or use Dupixent. You should not do both.

Driving and using machines
Dupixent is unlikely to influence your ability to drive and use machines.

Dupixent contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 300 mg dose, that is to say essentially ‘sodium-free’.

Dupixent contains polysorbate
This medicine contains 4 mg of polysorbate 80 in each 300 mg dose (2 mL). Polysorbates may cause allergic reactions. Tell your doctor if you have or your child has any known allergies.

3. How to use Dupixent

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much Dupixent you will receive
Your doctor will decide which dose of Dupixent is right for you.

Recommended dose in adults with atopic dermatitis
For patients with atopic dermatitis, the recommended dose of Dupixent is:
- An initial dose of 600 mg (two 300 mg injections)
- Followed by 300 mg given every other week by subcutaneous injection.

Recommended dose in adolescents with atopic dermatitis
The recommended dose of Dupixent for adolescents (12 to 17 years of age) with atopic dermatitis is based on body weight:

Body weight of patient
Initial dose
Subsequent doses
(every other week) less than 60 kg
400 mg (two 200 mg injections)
200 mg
60 kg or more
600 mg (two 300 mg injections)
300 mg

Recommended dose in children 6 to 11 years of age with atopic dermatitis
The recommended dose of Dupixent for children (6 to 11 years of age) with atopic dermatitis is based on body weight:

Body weight of patient
Initial dose
Subsequent doses

15 kg to less than 60 kg
300 mg (one 300 mg injection) on Day 1, followed by 300 mg on Day 15
300 mg every 4 weeks*, starting 4 weeks after Day 15 dose
60 kg or more
600 mg (two 300 mg injections)
300 mg every other week
* The dose may be increased to 200 mg every other week based on the doctor’s opinion.

Recommended dose in children 6 months to 5 years of age with atopic dermatitis

The recommended dose of Dupixent for children 6 months to 5 years of age with atopic dermatitis is based on body weight:

Body Weight of Patient
Initial Dose
Subsequent Doses
5 kg to less than 15 kg
200 mg (one 200 mg injection)
200 mg every 4 weeks
15 kg to less than 30 kg
300 mg (one 300 mg injection)
300 mg every 4 weeks

Recommended dose in adult and adolescent patients with asthma (12 years of age and older) For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid severe chronic rhinosinusitis with nasal polyposis, the recommended dose of Dupixent is:
- An initial dose of 600 mg (two 300 mg injections)
- Followed by 300 mg given every other week administered as subcutaneous injection.

For all other patients with severe asthma, the recommended dose of Dupixent is:
- An initial dose of 400 mg (two 200 mg injections)
- Followed by 200 mg given every other week administered as subcutaneous injection.

Recommended dose children with asthma
The recommended dose of Dupixent for children (6 to 11 years of age) with asthma is based on body weight:

Body weight of patient
Initial and subsequent doses
15 to less than 30 kg
300 mg every 4 weeks
30 kg to less than 60 kg

200 mg every other week or
300 mg every 4 weeks
60 kg or more
200 mg every other week

For patients 6 to 11 years old with asthma and coexisting severe atopic dermatitis, your doctor will decide which dose of Dupixent is right for you.

Recommended dose in adults with chronic rhinosinusitis with nasal polyposis (CRSwNP) In CRSwNP, the recommended first dose of Dupixent is 300 mg followed by 300 mg given every two weeks by subcutaneous injection.

Recommended dose in adults with prurigo nodularis (PN)
For patients with prurigo nodularis, the recommended dose of Dupixent is:
- An initial dose of 600 mg (two 300 mg injections)
- Followed by 300 mg given every other week by subcutaneous injection.

Recommended dose in adults, adolescents and children (1 year of age and older ) with eosinophilic esophagitis (EoE) Body Weight Dose ≥15 to <30 kg 200 mg every other week ≥30 to <40 kg 300 mg every other week ≥40 kg 300 mg every week

Recommended dose in adults with chronic obstructive pulmonary disease (COPD)
In COPD, the recommended dose of Dupixent is 300 mg given every other week by subcutaneous injection.

Recommended dose in adults with chronic spontaneous urticaria (CSU)
The recommended dose of Dupixent for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week.

Recommended dose in children and adolescents 6 to 17 years with chronic spontaneous urticaria (CSU):
The recommended dose of Dupixent for children and adolescents (6 to 17 years of age) with chronic spontaneous urticaria is based on body weight:* Body Weight Initial Dose Subsequent Doses 15 to less than 30 kg 300 mg (one 300 mg injection) on Day 1, followed by 300 mg on Day 15 300 mg every four weeks (Q4W), starting 4 weeks after Day 15 dose 30 to less than 60 kg 400 mg (two 200 mg injections) 200 mg every other week (Q2W) 60 kg or more 600 mg (two 300 mg injections) 300 mg every other week (Q2W) *For patients weighing 5 to less than 15 kg the recommended dose is 200 mg every 4 weeks (Q4W).

Recommended dose in children 2 to 5 years with chronic spontaneous urticaria (CSU):
The recommended dose of Dupixent for children (2 to 5 years of age) with chronic spontaneous urticaria is based on body weight:

Body Weight
Initial and subsequent doses
5 to less than 15 kg
200 mg every four weeks (Q4W)
15 to less than 30 kg
300 mg every four weeks (Q4W)

Injecting Dupixent
Dupixent is given by injection under your skin (subcutaneous injection). You and your doctor or nurse should decide if you should inject Dupixent yourself.

Before injecting Dupixent yourself you must have been properly trained by your doctor or nurse. Your Dupixent injection may also be given by a caregiver after proper training by a doctor or nurse.

Each pre-filled syringe contains one dose of Dupixent (300 mg). Do not shake the pre-filled syringe.

Read carefully the “Instructions for Use” included at the end of the package leaflet before using Dupixent.

If you use more Dupixent than you should
If you use more Dupixent than you should or the dose has been given too early, talk to your doctor, pharmacist or nurse.

If you forget to use Dupixent
If you have forgotten to inject a dose of Dupixent, talk to your doctor, pharmacist or nurse. In addition,

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 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 Dupixent injection.

If your dose schedule is every 4 weeks and you miss a dose of Dupixent:

give the Dupixent 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 every 4 week dose schedule from the time you remember to take your Dupixent injection.

If you stop using Dupixent
Do not stop using Dupixent without speaking to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Dupixent can cause serious side effects, including rare allergic (hypersensitivity) reactions, including anaphylactic reaction, serum sickness reaction, serum sickness-like reaction; the signs may include:
- breathing problems
- swelling of the face, lips, mouth, throat or tongue (angioedema)
- fainting, dizziness, feeling lightheaded (low blood pressure)
- fever
- general ill feeling
- swollen lymph nodes
- hives
- itching
- joint pain
- skin rash

If you develop an allergic reaction, stop using Dupixent and talk to your doctor right away.

Other side effects

Common (may affect up to 1 in 10 people):
- injection site reactions (e.g localized redness, swelling, itching, pain, bruising)
- eye redness and itching
- eye infection
- cold sores (on lips and skin)
- an increase in a certain kind of white blood cell (eosinophils)
- joint pain (arthralgia)

Uncommon (may affect up to 1 in 100 people):
- swelling of the face, lips, mouth, throat or tongue (angioedema)
- eyelid itching, redness and swelling
- inflammation of the eye surface, sometimes with blurred vision (keratitis)
- facial rash or redness
- eye dryness

Rare (may affect up to 1 in 1 000 people):
- serious allergic (hypersensitivity) reactions
- ulcers on the outer clear layer of the eye, sometimes with blurred vision (ulcerative keratitis)

Additional side effects in children 6 to 11 years old with asthma
Common: pinworms (enterobiasis)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dupixent

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C to 8 °C). Do not freeze. Store in the original carton to protect from light. If necessary, the pre-filled syringe can be removed from the refrigerator and kept in the pack for up to 14 days at room temperature up to 25 °C, while protected from light. The date of removal from the refrigerator shall be recorded in the space provided on the outer carton. The pack must be discarded if left out of the refrigerator for more than 14 days or if the expiry date has passed.

Do not use this medicine if you notice that the medicine is cloudy, discoloured, or has particles in it.
Do not throw away any medicines via wastewater or household waste. Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Dupixent contains
- The active substance is dupilumab.
- Each pre-filled syringe contains 300 mg of dupilumab in 2 mL solution for injection (injection).
- The other ingredients are L-Arginine monohydrochloride, L-Histidine, L-Histidine monohydrochloride monohydrate, Polysorbate 80 (E 433), Sodium acetate trihydrate, Acetic acid glacial (E 260), Sucrose, Water for injections.

What Dupixent looks like and contents of the pack
Dupixent is a clear to slightly opalescent, colourless to pale yellow solution supplied in a glass pre- filled syringe with needle shield.

Dupixent is available as 300 mg pre-filled syringes in a pack containing 1 or 2 pre-filled syringes or in multipack containing 6 (3 packs of 2) pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:
SANOFI WINTHROP INDUSTRIE
1051 Boulevard Industriel,
76580 LE TRAIT,
FRANCE

Genzyme Ireland Limited
IDA Industrial Park
Old Kilmeaden Road
Waterford
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 04 36 996
Tel. aus dem Ausland: +49 69 305 70 13

Nederland
Sanofi B.V.
Tel: + 31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop IndustrieTél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000
Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu

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Dupixent 300 mg solution for injection in a pre-filled syringe with needle shield dupilumab

Instructions for use

The parts of the Dupixent pre-filled syringe with needle shield are shown in this picture.

Important information
This device is a single-use pre-filled syringe. It contains 300 mg of Dupixent for injection under the skin (subcutaneous injection).

You must not try to give yourself or someone else the injection unless you have received training from your healthcare professional. In adolescents 12 years and older, it is recommended that Dupixent is administered by or under supervision of an adult. In children less than 12 years of age, Dupixent should be given by a caregiver.

Read all of the instructions carefully before using the syringe.
Check with your healthcare professional how often you will need to inject the medicine.
Ask your healthcare professional to show you the right way to use the syringe before you inject for the first time.
Change the injection site for each injection.
Do not use the syringe if it has been dropped on a hard surface or damaged.
Do not use the syringe if the needle cap is missing or not securely attached.
Do not touch the plunger rod until you are ready to inject.
Do not inject through clothes.
Do not get rid of any air bubbles in the syringe.
To help prevent accidental needle injury, each pre-filled syringe has a needle shield that is automatically activated to cover the needle after you have given your injection.
Never pull back on the plunger rod.
Do not re-use the syringe.

How to Store Dupixent

Keep the syringe(s) out of the reach of children.
Keep unused syringes in the original carton and store in the refrigerator between 2 ºC and 8 ºC.
Do not keep Dupixent at room temperature (< 25 ºC) for more than 14 days. If you need to permanently remove the carton from the refrigerator, write down the date of removal in the space provided on the outer carton, and use Dupixent within 14 days.
Do not shake the syringe at any time.
Do not heat the syringe.

Do not freeze the syringe.
Do not place the syringe into direct sunlight.

Step 1: Remove

Remove the syringe from the carton by holding the middle of the syringe body.
Do not pull off the needle cap until you are ready to inject.
Do not use the syringe if it has been dropped on a hard surface or damaged.

Step 2: Prepare

Ensure you have the following:
the Dupixent pre-filled syringe
1 alcohol wipe*
1 cotton ball or gauze* a puncture-resistant container* (See Step 12)

*Items not included in the carton

Look at the label:
Check the expiry date.
Check that you have the correct product and dose.
Do not use the syringe if the expiry date has passed.
Do not keep Dupixent at room temperature for more than 14 days.

Step 3: Inspect

Look at the medicine through the viewing window on the syringe:

Check if the liquid is clear and colourless to pale yellow.

Note: You may see an air bubble; this is normal.

Do not use the syringe if the liquid is discoloured or cloudy, or if it contains flakes or particles.

Step 4: Wait 45 minutes

Lay the syringe on a flat surface for at least 45 minutes and let it get to room temperature naturally.

Do not warm the syringe in a microwave, hot water, or direct sunlight.
Do not place the syringe in direct sunlight.
Do not keep Dupixent at room temperature for more than 14 days.

Step 5: Choose

Select the injection site.
You can inject into your thigh or belly (stomach), except for the 5 cm around your navel.
If somebody else gives you the injection, they can also use your upper arm.
Change the injection site for each injection.

Do not inject into skin that is tender, damaged or has bruises or scars.

Step 6: Clean

Wash your hands.

Clean the injection site with an alcohol wipe.

Let your skin dry before injecting.

Do not touch the injection site again or blow on it before the injection.

Step 7: Pull

Hold the syringe in the middle of the syringe body with the needle pointing away from you and pull off the needle cap.

Do not put the needle cap back on.
Do not touch the needle.

Inject your medicine immediately after removing the needle cap.

Step 8: Pinch

Pinch a fold of skin at the injection site, as shown in the picture.

Step 9: Insert

Insert the needle completely into the fold of skin at roughly a 45º angle.

Step 10: Push

Relax the pinch.

Push the plunger rod down slowly and steadily as far as it will go until the syringe is empty.

Note: You will feel some resistance. This is normal.

Step 11: Release and Remove

Lift your thumb to release the plunger rod until the needle is covered by the needle shield and then remove the syringe from the injection site.
Lightly press a cotton ball or gauze on the injection site if you see any blood.

Do not put the needle cap back on.
Do not rub your skin after the injection.

Step 12: Dispose

Dispose of the syringe and the needle cap in a puncture-resistant container.

Do not put the needle cap back on.

Always keep the container out of the reach of children.

Package leaflet: Dupixent 300 mg solution for injection in pre-filled pen

1. What Dupixent is and what it is used for

What Dupixent is
Dupixent contains the active substance dupilumab.

Dupilumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called interleukins (IL)-4 and IL-13. Both play a major role in causing the signs and symptoms of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis (PN), eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria (CSU).

What Dupixent is used for
Dupixent is used to treat adults and adolescents 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema. Dupixent is also used to treat children 6 months to 11 years old with severe atopic dermatitis (see section Children and adolescents). Dupixent may be used with eczema medicines that you apply to the skin or it may be used on its own.

Dupixent is also used with other asthma medicines for the maintenance treatment of severe asthma in adults. Adolescents, and children aged 6 years and older whose asthma is not controlled with their current asthma medicines (e.g. corticosteroids).