Patient leaflet - DUPIXENT 200 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 and chronic
spontaneous urtircaria (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).
Dupixent is also used to treat chronic spontaneous urticaria (CSU) in adults and adolescents aged
12 years and older.
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.
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
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 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 promptly if you have any new
or worsening eye problems. These may include
watering, itching, redness and swelling, eye dryness, a feeling of gritty eyes or a sensation
of a foreign body in the eye. If you experience
sudden changes in vision or significant eye pain that does not settle, speak to your doctor straight away.
Children and adolescents
The Dupixent pre-filled pen is not intended
for use in children below 2 years of age.
For children aged 6 months to less than
2 years of age, contact your doctor who will
prescribe the appropriate Dupixent pre-filled
syringe.
In children 6 months to less than 12 years
of age, dupilumab should be given by a caregiver.
- In children 12 years of age and older, it is recommended that dupilumab is administered by or under supervision of an adult.
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 CSU
below the age of 12 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 200 mg dose, that is to say essentially ’sodium-free’.
Dupixent contains polysorbate
This medicine contains 2.28 mg of polysorbate
80 in each 200 mg dose (1.14 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 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 most 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.
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.
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 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 adolescents with chronic spontaneous urticaria (CSU)
The recommended dose of Dupixent for
adolescents (12 to 17 years of age) with chronic spontaneous urticaria is based on body weight:
Body Weight | Initial Dose | Subsequent Doses |
|---|---|---|
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) |
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 pen contains one dose of Dupixent
200 mg. Do not shake the pre-filled pen.
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*
*These eye side effects were common (up to 1 in
10 people) in patients with atopic dermatitis
Rare (may affect up to 1 in 1000 people):
- serious allergic (hypersensitivity) reactions
ulcers on the outer clear layer of the eye,
sometimes with blurred vision (ulcerative keratitis)*
*The side effect of ulcerative keratitis was uncommon (up to 1 in 100 people) in patients with atopic dermatitis
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA in the Google Play or Apple App
Store.
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 pen 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 pen contains 200 mg of dupilumab in 1.14 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 pre-filled pen.
The pre-filled pen may either have a round cap and oval viewing window encircled with an arrow or may have a square cap with ridges and an oval viewing window without an arrow. Although there are minor differences in the appearance of the two pre-filled pens, they both function the same.
Dupixent is available as 200 mg pre-filled pens in a pack containing 2 pre-filled pens.
Manufacturer
Sanofi-Aventis Deutschland GmbH, Brüningstrasse 50 Industriepark Hoechst, 65926 FRANKFURT AM MAIN, GERMANY.
Product procured from within the EU and repackaged by PCO Manufacturing Ltd.,
Unit 10, Ashbourne Business Park, Rath,
Ashbourne, Co. Meath, Ireland.
Product Licence Holder: Ecosse Pharmaceuticals Limited, 3 Young Place, East Kilbride, G75 0TD
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Dupixent is a registered trademark of SANOFI BIOTECHNOLOGY.
PL 19065/0942
This leaflet was last revised in 18.12.2025
If you are blind or partially sighted and require this leaflet in a different format, call
01355 574450 and ask for the Regulatory Department
Dupixent 200 mg The parts of the Dupixent pre-filled pen
200 mg of Dupixent for injection under the skin
older, it is recommended that Dupixent is administered
than 12 years of age, Dupixent should be given by a caregiver. The Dupixent pre-filled pen is only for use in
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removal in the space provided on the outer carton, and use Dupixent within 14 days. How to Store Dupixent
- the Dupixent pre-filled pen
(See Step D)
Do not keep Dupixent at room
Lay the pre-filled pen on a flat surface and let it naturally warm up at room temperature (less than 25ºC) for at least 30 minutes. Do not warm the pre-filled pen in a microwave, hot water, or direct sunlight. Do not put the pre-filled pen into direct sunlight. Do not keep Dupixent at room temperature for more than 14 days. |
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Choose a different injection site for each Dupixent injection. Do not inject through clothes. Do not inject into skin that is tender, damaged, bruised or scarred. |
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Do not give yourself a second dose without speaking to your