Dupixent® 200 mg – patient leaflet, side effects, dosage

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.

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How Dupixent works

Parasitic (intestinal parasites) infection

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 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.

  therefore, it is preferable to avoid the use of Dupixent in pregnancy unless your doctor advises to use it.

  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:

  • If you are breast-feeding or are planning

• Check with your doctor if you have

  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.

  diarrhoea, gas, upset stomach, greasy stools, and dehydration which could be a sign of a parasitic infection.

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.

• If you live in a region where these

infections are common or if you are travelling to such a region check with your doctor.

Driving and using machines

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

Asthma

Dupixent contains sodium

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.

This medicine contains less than 1 mmol sodium (23 mg) per 200 mg dose, that is to say essentially 'sodium-free'.

2. What you need to know before you use Dupixent

Recommended dose in adult and adolescent patients with asthma (12 years of age and older)

Dupixent contains polysorbate

Do not use Dupixent

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.

• if you are allergic to dupilumab or any

  For most patients with severe asthma, the recommended dose of Dupixent is:

  of the other ingredients of this medicine (listed in section 6).

  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.

  • An initial dose of 400 mg (two 200 mg

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

injections)

• Followed by 200 mg given every other

3. How to use Dupixent

week administered as subcutaneous injection.

Talk to your doctor, pharmacist or nurse before using 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.

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:

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

Children and adolescents

• The Dupixent pre-filled pen is not

  How much Dupixent you will receive

  intended for use in children below 2 years of age.

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

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

• For children aged 6 months to less than

  • An initial dose of 600 mg (two 300 mg

Recommended dose in adolescents with atopic dermatitis

2 years of age contact your doctor who will prescribe the appropriate Dupixent pre-filled syringe.

injections)

• Followed by 300 mg given every other

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

week administered as subcutaneous injection.

• In children 6 months to less than 12

  years of age, dupilumab should be given by a caregiver.

• Rarely, Dupixent can cause serious

  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:

  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.

• 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.

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:

• The safety and benefits of Dupixent

are not yet known in children with CSU below the age of 12 years.

Other medicines and Dupixent

• Stop using Dupixent and tell your doctor

or get medical help immediately if you notice any signs of an allergic reaction. Eosinophilic conditions

Tell your doctor or pharmacist

• if you are using, have recently used or

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.

might use any other medicines.

• if you have recently had or are due to

• Rarely patients taking an asthma

  have a vaccination.

  medicine may develop inflammation of blood vessels or lungs due to an increase of certain white blood cells (eosinophilia).

Other medicines for asthma

Recommended dose in adults with chronic spontaneous urticaria (CSU)

Do not stop or reduce your asthma medicines, unless instructed by your doctor.

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.

• It is not known whether this is caused

  • These medicines (especially ones called

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.

corticosteroids) must be stopped gradually.

• This must be done under the direct

  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:

supervision of your doctor and dependent on your response to Dupixent.

• Tell your doctor immediately if you

  Pregnancy and breast-feeding

  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.

  *The dose may be increased to 200 mg every other week based on the doctor’s opinion.

  • 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;

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 1, 2, or 6 pre-filled pens or in a pack containing 6 (2 packs of 3) pre-filled pens.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Sanofi

410 Thames Valley Park Drive

Reading

Berkshire

RG6 1PT

UK

Tel : 0800 035 2525

Email : uk-medicalinformation@sanofi.com

Manufacturer:

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

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.

This leaflet was last revised in October 2025

Dupixent 200 mg solution for injection in a pre-filled pen

dupilumab

Instructions for use

The parts of the Dupixent pre-filled pen

are shown in this picture.

Before Injection After Injection

Yellow Cap

Medicine Yellow Cap

Label Orange Needle Cover

(Removed)

(Needle inside)

Important information How to Store Dupixent

This device is a single-use pre-filled pen. It contains 200 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. The Dupixent pre-filled pen is only for use in adults and children aged 2 years and older.

• Read all of the instructions carefully before using the pre-filled pen.
• Ask your healthcare professional how often you will need to inject the medicine.
• Choose a different injection site for each injection
• Do not use the pre-filled pen if it has been damaged.
• Do not use the pre-filled pen if the yellow cap is missing or not securely attached.
• Do not press or touch the orange needle cover with your fingers.
• Do not inject through clothes.
• Do not remove the yellow cap until just before you give the injection.
• Do not try to put the yellow cap back on the pre-filled pen.

• Do not re-use the pre-filled pen.

  • Keep the pre-filled pen(s) and all medicines out of the reach of children.
  • Keep unused pre-filled pens in the original carton and store in the refrigerator between 2ºC and 8ºC.
  • Store pre-filled pens in the original carton to protect it from light.
  • Do not keep pre-filled pens at room temperature (<25ºC) 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 pre-filled pen at any time.
  • Do not heat the pre-filled pen.
  • Do not freeze the pre-filled pen.
  • Do not place the pre-filled pen into direct sunlight.

A Prepare

B Choose your injection site

A1 Gather supplies

A2 Look at the label A3 Check expiration date A4 Check the medicine A5 Wait 30 minutes B1 Recommended injection sites are:

B2 Wash your hands

Ensure you have the following:

• the Dupixent pre-filled pen
• 1 alcohol wipe*
• 1 cotton ball or gauze*
• a puncture-resistant container* (See Step D)

*Items not included in the carton

Look at the Label

• Confirm that you have the correct product and

  dose.

  Expiration Date

  • Check the expiration date.

    Do not use the pre-filled pen if the expiration date has passed.

    Do not keep Dupixent at room temperature for more than 14 days.

    Check

    Window

    Look at the medicine through the window on the pre-filled pen.

    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 pre-filled pen if the liquid is discolored or cloudy, or if it contains visible flakes or particles.

    Do not use the pre-filled pen if the window is yellow.

    30

    minutes

    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.

    Injection by

    caregiver only

    Self-injection or

    by caregiver

    Self-injection or by caregiver

    Injection by caregiver only

    • Thigh
    • Stomach except for the 5 cm around your belly button (navel).
    • Upper Arm If a caregiver gives your dose, they can also use the outer area of the upper arm.

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.

B3 Prepare the injection site

• 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.

C Give injection

D Dispose

C1 Remove yellow cap C2 Pinch and Place C3 Press down C4 Hold firmly C5 Remove

Pull the Yellow Cap straight off.

Correct

FIRST

CLICK

Pinching of the skin

is not needed for

adults and children

aged 12 years and

older.

Check

Yellow

Window Then slowly count to 5

Pinching of the skin is not needed for adults and children aged 12 years and older.

Pre-filled Pen

Yellow Cap

Needle inside

1...2...3...4...5

Pinch Skin

Incorrect

Pull the yellow cap straight off.

Do not twist the yellow cap off.

Do not remove the yellow cap until you are ready to inject. Do not press or touch the orange needle cover with your fingers. The needle is inside.

Do not put the yellow cap back on the pre-filled pen after you have removed it.

• Pinch the skin before and during the injection.

• Pinching is not needed for adults and children aged 12 years and

  older.

• When placing the orange needle cover on your skin, hold the pre-filled

  pen so that you can see the window.

• Place the orange needle cover on your skin at approximately

  a 90-degree angle.

  Do not press or touch the orange needle cover with your fingers.

  The needle is inside.

  Press the pre-filled pen firmly against your skin until you cannot see the orange needle cover, and hold.

  • There will be a “click” when the injection starts.
  • The window will start to turn yellow.

The injection can take up to 15 seconds.

Keep holding the pre-filled pen firmly against your skin.

• You may hear a second click.
• Check that the entire window has turned to yellow.
• Then slowly count to 5.
• Then lift the pen up off the skin, your injection is complete.

If the window does not turn completely yellow, remove the pen and call your healthcare provider.

Do not give yourself a second dose without speaking to your healthcare provider.

• After you have completed your injection pull straight up to remove

  pre-filled pen from the skin and dispose of immediately as described in section D.

• If you see any blood at the site, lightly dab a cotton ball or gauze pad.

  Do not rub your skin after the injection.

  • Dispose of the pre-filled pens, (needle inside), and yellow caps in a puncture resistant container right away after use.

Do not dispose of (throw away) pre-filled pens (needle inside), and yellow caps in your household trash.

Do not put the yellow cap back on.