Dupixent: detailed information

Package leaflet: Information for the user

Dupixent 300 mg solution for injection in pre-filled syringe

dupilumab
Read this entire leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Dupixent is and what it is used for
What you need to know before using Dupixent
How to use Dupixent
Possible side effects
How to store Dupixent
Contents of the pack and other information

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 interleukin (IL)-4 and IL-13. Both of these proteins play a key role in causing the signs and symptoms of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), nodular prurigo (NP), eosinophilic oesophagitis (EoE), chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria (CSU).

What Dupixent is used for
Dupixent is used to treat adults and adolescents aged 12 years and older with moderate to severe atopic dermatitis, also known as atopic eczema. Dupixent is also used to treat children from 6 months to 11 years of age with severe atopic dermatitis. Dupixent may be used alone or together with topical eczema medications applied to the skin.

Dupixent is also used together with other asthma medications 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 medications (e.g., corticosteroids).

Dupixent is also used in combination with other medications for the maintenance treatment of CRSwNP in adults whose disease is not controlled with their current CRSwNP medications.
Dupixent may also reduce the need for surgery and the need for systemic corticosteroids.

Dupixent is also used to treat adults with moderate to severe nodular prurigo (NP), also known as chronic nodular prurigo (CNPG). Dupixent may be used in combination with topical NP medications applied to the skin or alone.

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

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

Dupixent is also used to treat adults and adolescents aged 12 years and older with moderate to severe chronic spontaneous urticaria (CSU) not controlled with antihistamines, who have not received immunoglobulin E (IgE) inhibitor drugs for their CSU.

How Dupixent works
Using Dupixent for atopic dermatitis (atopic eczema) can improve skin condition 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 sleep disturbances and overall quality of life.

Dupixent helps prevent severe asthma attacks (exacerbations) and can improve breathing.
Dupixent may also help reduce the amount of other medications needed to control asthma, known as oral corticosteroids, by preventing severe asthma attacks and improving breathing.

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

Using Dupixent for CSU can improve skin condition by reducing itching and hives.

2. What you need to know before using Dupixent

Do not use Dupixent

if you are allergic to dupilumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, or if you are unsure, ask your doctor, pharmacist, or nurse 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 an acute asthma or COPD attack.
Each time you obtain a new pack of Dupixent, it is important to record the name of the medicine, the date of administration, and the batch number (found on the pack after "Batch") and keep this information in a safe place.

Allergic reactions

Rarely, Dupixent may cause serious side effects, including allergic reactions (hypersensitivity), anaphylactic reaction, and angioedema. These reactions may occur within minutes up to 7 days after administration of Dupixent. While taking Dupixent, be alert for symptoms that may be related to these types of reactions (e.g. breathing difficulties, swelling of the face, lips, mouth, throat, or tongue, fainting, dizziness, lightheadedness (low blood pressure), fever, general feeling of being unwell, swollen lymph nodes, hives, itching, joint pain, rash). These symptoms are listed in section 4 under “Serious undesirable effects”.
Stop using Dupixent and contact your doctor or seek immediate medical help if you notice any symptoms of an allergic reaction.

Conditions related to eosinophilia

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

Parasitic infection (intestinal parasites)

Dupixent may weaken your resistance to infections caused by parasites. If you already have a parasitic infection, you should be treated for it before starting treatment with Dupixent.
Talk to your doctor if you have diarrhoea, gas, stomach discomfort, oily stools, or dehydration, which may be signs of a parasitic infection.
Talk to your doctor if you live in an area where such infections are common or if you plan to travel to such an area.

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

Eye problems
Inform your doctor if you notice any eye symptoms or worsening of an existing eye problem, including eye pain or changes in vision.

Children and adolescents

The safety and benefits of Dupixent have not yet been established in children under 6 months of age with atopic dermatitis.
The safety and benefits of Dupixent have not yet been established in children under 6 years of age with asthma.
The safety and benefits of Dupixent have not yet been established in children under 18 years of age with CRSwNP.
The safety and benefits of Dupixent have not yet been established in children under 18 years of age with PN.
The safety and benefits of Dupixent have not yet been established in children under 1 year of age or with body weight < 15 kg with EoE.
The safety and benefits of Dupixent have not yet been established in children under 18 years of age with COPD.
The safety and benefits of Dupixent have not yet been established in children under 12 years of age with CSU.

Other medicines and Dupixent
Inform your doctor or pharmacist:

if you are currently using, have recently used, or might use any other medicines.
if you have recently received or are due to receive a vaccination.

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

These medicines (especially those called corticosteroids) should be stopped gradually.
This must be done under the direct supervision of your doctor and based on your response to Dupixent.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning a pregnancy, ask your doctor for advice before taking this medicine. The effects of this medicine in pregnant women are unknown; therefore, it is preferable to avoid using Dupixent during pregnancy unless your doctor specifically instructs you to do so.
If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine. You and your doctor will need to decide whether to breastfeed or use Dupixent. You should not do both.

Driving and using machines
It is unlikely that Dupixent will affect your ability to drive or use machines.

Dupixent contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 300 mg dose, i.e. essentially ‘sodium-free’.

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

3. How to use Dupixent

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
How much Dupixent you will receive
Your doctor will decide which dose of Dupixent is suitable 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 injections of 300 mg)
Followed by 300 mg every other week via subcutaneous injection.

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

Patient body weight	Initial dose	Subsequent doses (given 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 aged 6 to 11 years with atopic dermatitis
The recommended dose of Dupixent for children (aged 6 to 11 years) with atopic dermatitis is based on body weight:

Body weight of the patient	Initial dose	Subsequent doses
From 15 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 the 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 2 weeks based on the physician's assessment.
Recommended dose in children aged 6 months to 5 years with atopic dermatitis
The recommended dose of Dupixent for children aged 6 months to 5 years with atopic dermatitis is
based on body weight:

Patient body weight	Initial dose	Subsequent doses
From 5 kg to less than 15 kg	200 mg (one 200 mg injection)	200 mg every 4 weeks
From 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 (age 12 years and older)
For patients with severe asthma who are on oral corticosteroid treatment, or for patients with severe asthma and concomitant moderate to severe atopic dermatitis, or adults with concomitant severe chronic rhinosinusitis with nasal polyposis, the recommended dose of dupilumab is:

An initial dose of 600 mg (two injections of 300 mg)
Followed by 300 mg administered every other week as a subcutaneous injection.

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

An initial dose of 400 mg (two injections of 200 mg)
Followed by 200 mg administered every other week as a subcutaneous injection.

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

Body weight of the patient	Initial and subsequent doses
from 15 to less than 30 kg	300 mg every 4 weeks
from 30 to less than 60 kg	200 mg on alternate weeks or 300 mg every 4 weeks
60 kg or more	200 mg on alternate weeks

For patients aged 6 to 11 years with coexisting asthma and severe atopic dermatitis, the physician will decide which dose of Dupixent is appropriate.

Recommended dose in adults with chronic rhinosinusitis with nasal polyposis (CRSwNP)
In CRSwNP, the recommended initial dose is 300 mg, followed by 300 mg every other week, administered as a subcutaneous injection.

Recommended dose in adults with nodular prurigo (PN)
For patients with nodular prurigo, the recommended dose of Dupixent is:

An initial dose of 600 mg (two 300 mg injections)
Followed by 300 mg every other week via subcutaneous injection.

Recommended dose in adult, adolescent, and pediatric patients (aged 1 year 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 weekly

Recommended dose in adult patients with chronic obstructive pulmonary disease (COPD)
In COPD, the recommended dose of Dupixent is 300 mg administered every other week as a subcutaneous injection.

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

Recommended dose in adolescents with chronic spontaneous urticaria (CSU)
The recommended dose of Dupixent for adolescents (aged 12 to 17 years) with chronic spontaneous urticaria is based on body weight:

Body weight	Initial dose	Subsequent doses
From 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 administered by injection under the skin (subcutaneous injection). You and your doctor or
nurse must decide whether you should self-inject Dupixent.
Before self-injecting Dupixent, you must have received adequate training from your doctor or nurse.
A caregiver may also administer the Dupixent injection after receiving adequate training from a doctor or
nurse.
Each prefilled syringe contains one dose of Dupixent (300 mg). Do not shake the prefilled syringe.
Read the "Instructions for use" included at the end of the package leaflet carefully before using

Dupixent.

If you use more Dupixent than you should
If you use more Dupixent than you should, or if the dose was taken earlier than scheduled, inform your doctor,
pharmacist, or nurse.

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

If your dosing schedule is every week and you miss a dose of Dupixent:

inject the missed dose of Dupixent as soon as possible and start a new weekly dosing schedule from the time you remember to administer the injection.

If your dosing schedule is every other week and you miss a dose of Dupixent:

inject the missed dose of Dupixent within 7 days after the missed dose, then continue with your original dosing schedule.
if the missed dose has not been administered within 7 days, wait for the next scheduled dose and inject Dupixent at that time.

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

inject the missed dose of Dupixent within 7 days after the missed dose, then continue with your original dosing schedule.
if the missed dose has not been administered within 7 days, start a new dosing schedule every 4 weeks, beginning from the time you remember to administer the injection.

If you stop treatment with Dupixent
Do not stop using Dupixent without first talking to your doctor. If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Dupixent may cause serious side effects, including rare allergic reactions (hypersensitivity), anaphylactic reaction, serum sickness, serum sickness-like reaction; signs may include:

breathing problems
swelling of the face, lips, mouth, throat or tongue (angioedema)
fainting, dizziness, feeling lightheaded (low blood pressure)
fever
feeling generally unwell
swollen lymph nodes
hives
itching
joint pain
rash If you experience an allergic reaction, stop using Dupixent and inform your doctor immediately. Other side effects Common (may affect up to 1 in 10 people):
injection site reactions (e.g. local redness, swelling, itching, pain, bruising)
eye redness and eye itching
eye infection
cold sores (on lips and skin)
increase in a certain type of white blood cells (eosinophils)
joint pain (arthralgia) Uncommon (may affect up to 1 in 100 people):
swelling of the face, lips, mouth, throat or tongue (angioedema)
itching, redness and swelling of the eyelids
inflammation of the surface of the eye, sometimes with blurred vision (keratitis)
facial rash or redness
dry eyes Rare (may affect up to 1 in 1,000 people):
severe allergic reactions (hypersensitivity)
ulcers on the clear outer layer of the eye, sometimes with blurred vision (ulcerative keratitis) Additional side effects in children aged 6 to 11 years with asthma Common: pinworm infestation (enterobiasis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex 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 stated on the label and carton following "Exp".
The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep in the original packaging to protect from light.
If necessary, the pre-filled syringe may be removed from the refrigerator and stored in its packaging for up to 14 days at room temperature not exceeding 25°C, protected from light. The date when removed from the refrigerator should be recorded in the designated space on the outer carton. The carton must be discarded if left outside the refrigerator for more than 14 days or if the expiry date has passed.
Do not use this medicine if you notice that the solution is cloudy, has changed colour, or contains particles.
Do not dispose of any medicine via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Dupixent contains

The active substance is dupilumab.
Each pre-filled syringe contains 300 mg of dupilumab in 2 mL of injectable solution (injection).
The other components are L-arginine monohydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E433), sodium acetate trihydrate, glacial acetic acid (E260), sucrose, water for injections.

Description of the appearance of Dupixent and contents of the pack
Dupixent is a solution ranging from clear to slightly opalescent, colourless to pale yellow, supplied in a glass pre-filled syringe with or without a needle cap. Dupixent is available in 300 mg pre-filled syringes in packs containing 1 or 2 pre-filled syringes, or in a multiple pack 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Sanofi Belgium
Swixx Biopharma UAB
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 Industrie
Tél: 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

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu

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

Instructions for use

The components of the Dupixent pre-filled syringe with needle guard are shown in this image.

Technical diagram of a prefilled syringe with components labeled by guide lines indicating plunger, barrel, needle, and cap

Important information
This device is a single-use pre-filled syringe. It contains 300 mg of Dupixent for injection under the
skin (subcutaneous injection).
Do not attempt to administer the injection yourself or have someone else administer it without first receiving
training from a healthcare provider. In adolescents aged 12 years and older, Dupixent should be administered by or under the supervision of an adult. In children under 12 years of age, Dupixent must be administered by a caregiver.

Read all instructions carefully before using the syringe.
Check with your healthcare provider how often you should inject the medicine.
Ask your healthcare provider to show you how to correctly use the syringe before your first injection.
Change the injection site each time you inject.
Do not use the syringe if it has fallen on a hard surface or if it is 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 clothing.
Do not try to remove any air bubbles in the syringe.
To prevent accidental needle injury, each pre-filled syringe is equipped with an automatic needle guard that activates to cover the needle after the injection is administered.
Do not pull back on the plunger rod.
Do not reuse the syringe.

How to store Dupixent

Keep the syringe(s) out of the reach of children.
Keep unused syringes in their original packaging and store them in the refrigerator at a temperature between 2 °C and 8 °C.
Do not store Dupixent at room temperature (<25 ºC) for more than 14 days. If you need to permanently remove the package from the refrigerator, write the removal date in the designated space on the outer carton and use Dupixent within 14 days.
Do not shake the syringe.
Do not heat the syringe.
Do not freeze the syringe.
Do not place the syringe in direct sunlight.

Step 1: Removal
Remove the syringe from the packaging by holding it at the center of the syringe barrel.

Two identical warning symbols consisting of a yellow triangle with black border and a black exclamation mark at the center

Do not remove the needle cap until you are ready to inject.
Do not use the syringe if it has fallen on a hard surface or if it is damaged.

A hand holding a syringe with needle above an open cardboard box with internal compartments for drug containment

Step 2: Preparation
Make sure you have the following items:

the pre-filled syringe with Dupixent
1 alcohol wipe*
1 cotton ball or gauze*
a puncture-resistant container* (see Step 12)
*Items not included in the package

Check the label:

Verify the expiration date.
Confirm you have the correct product and dose.

Hazard symbol composed of a yellow triangle with black border and a black exclamation mark at the center

Do not use the syringe if the expiration date has passed.

Warning symbol with a black exclamation mark at

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

Technical drawing of a syringe labeled with batch number 3LN58A and expiration date 02/2018 with an indicator arrow

Step 3: Inspection
Look at the medicine through the inspection window on the syringe:
Ensure the liquid is clear and colorless to pale yellow.
Note: An air bubble may be visible; this is normal.

Hazard sign composed of a yellow triangle with black border and a black exclamation mark at the center

Do not use the syringe if the liquid has changed color, is cloudy, or contains flakes or
particles.

Technical drawing of a medical device with a viewing window showing batch number and expiration date on a white background

Step 4: Wait 45 minutes
Place the syringe on a flat surface for at least 45 minutes to allow it to warm to room temperature naturally.

Two identical warning symbols consisting of a yellow triangle with black border and a black exclamation mark at the center on a white background

Do not heat the syringe in a microwave, in warm water, or in direct sunlight.
Do not place the syringe in direct sunlight.

Warning symbol composed of a yellow triangle with black border containing a black exclamation mark at the center

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

Analog clock with green dial indicating a 45-minute interval above a white syringe with plunger and needle

Step 5: Choose
Select the injection site.

You may inject in the thigh or abdomen (stomach), except within 5 cm of the navel.
If someone else is administering the injection, the upper arm may also be used.
Change the injection site with each injection.

Warning symbol composed of a yellow triangle with black border and a black exclamation mark at the center

Do not inject into areas of skin that are tender, damaged, bruised, or scarred.

Human body diagram with blue zones on arms for assisted injection and light blue zones on abdomen and thighs for self-injection or assisted injection

Step 6: Clean
Wash your hands.
Clean the injection site with an alcohol wipe.
Allow the skin to dry before injecting.

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

A hand applying a small square adhesive patch onto the skin of the

Step 7: Remove
Hold the syringe in the middle of the barrel with the needle pointing away from yourself and remove the needle cap.

Do not re-cap the needle.
Do not touch the needle.
Inject immediately after removing the needle cap.

Two hands moving a syringe with a needle back and forth to connect it to a vial with black directional arrows above

Step 8: Pinch
Pinch a fold of skin at the injection site as shown.

Step 9: Insertion
Insert the needle fully into the skin fold at an angle of approximately 45º.

Two hands holding a syringe at a 45-degree angle to the skin with a black arrow indicating downward pressure movement

Step 10: Injection
Release the pinched skin.
Push the plunger rod down slowly and steadily until it stops and the syringe is empty.
Note: You may feel slight resistance. This is normal.

A hand pressing a cylindrical medical device against the

Step 11: Release and removal
Lift your thumb to release the plunger rod until the needle is covered by the needle guard, then remove the syringe from the injection site.
If you see blood, gently press a cotton ball or gauze over the injection site.

Do not re-cap the needle.
Do not rub the skin after injection.

A hand holding a syringe-shaped medical device to apply it to the skin of the

Step 12: Disposal
Dispose of the syringe and needle cap in a puncture-resistant container.

Do not re-cap the needle.
Always keep this container out of the reach of children.

A hand holding a needle cap above a syringe being inserted into the neck of a medical vial for drug withdrawal

Patient Information Leaflet: Information for the User

Dupixent 300 mg solution for injection in pre-filled pen

dupilumab
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Dupixent is and what it is used for
What you need to know before using Dupixent
How to use Dupixent
Possible side effects
How to store Dupixent
Contents of the pack and other information

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 interleukin (IL)-4 and IL-13. Both of these proteins play a key role in causing the signs and symptoms of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), nodular prurigo (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 aged 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema. Dupixent is also used to treat children from 6 months to 11 years of age with severe atopic dermatitis (see section Children and adolescents). Dupixent may be used alone or together with topical eczema medications.

Dupixent is used in combination with other asthma medications 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 medications (e.g., corticosteroids).

Dupixent is also used in combination with other medications for the maintenance treatment of CRSwNP in adults whose disease is not controlled with their current CRSwNP medications. Dupixent may also reduce the need for surgery and the need for systemic corticosteroids.

Dupixent is also used to treat adults with moderate-to-severe nodular prurigo (NP), also known as chronic nodular prurigo (CNPG). Dupixent may be used in combination with topical medications for NP or alone.

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

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

Dupixent is also used to treat adults and adolescents aged 12 years and older with moderate-to-severe chronic spontaneous urticaria (CSU) not controlled with antihistamines, who have not received immunoglobulin E (IgE) inhibitor drugs for their CSU.

Dupixent helps prevent severe asthma attacks (exacerbations) and can improve breathing. Dupixent may also help reduce the amount of other medications needed to control asthma, known as oral corticosteroids, by preventing severe asthma attacks and improving breathing.

Dupixent helps prevent moderate or severe COPD flare-ups (exacerbations) and can improve breathing. Dupixent may also help improve overall COPD symptoms.

Using Dupixent for CSU can improve skin condition by reducing itching and hives.

2. What you should know before using Dupixent

Do not use Dupixent

if you are allergic to dupilumab or to any of the other ingredients of this medicine (listed in section 6); if you think you may be allergic, or if you are unsure, ask your doctor, pharmacist, or nurse 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 sudden asthma or COPD attacks.
Each time you receive a new pack of Dupixent, it is important to record the name of the medicine, the date of administration, and the batch number (found on the pack after "Lotto") and keep this information in a safe place.

Allergic reactions

Rarely, Dupixent may cause serious side effects, including allergic reactions (hypersensitivity), anaphylactic reaction, and angioedema. These reactions may occur within minutes up to 7 days after administration of Dupixent. While taking Dupixent, pay attention to symptoms that may be related to such reactions (e.g., breathing difficulties, swelling of the face, lips, mouth, throat, or tongue, fainting, dizziness, lightheadedness (low blood pressure), fever, general feeling of being unwell, swollen lymph nodes, hives, itching, joint pain, rash). These symptoms are listed in section 4 under "Serious side effects".
Stop using Dupixent and consult your doctor or seek immediate medical help if you notice any symptoms of an allergic reaction.

Conditions related to eosinophilia

Rarely, patients taking medicine for asthma may develop inflammation of blood vessels or lungs due to an increase in certain white blood cells (eosinophilia).
It is not known whether this is caused by Dupixent. This usually, but not always, occurs in people who are also taking a steroid medicine that is being stopped or whose dose is being reduced.
Inform your doctor immediately if you develop a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms and/or skin rash.

Parasitic infection (intestinal parasites)

Dupixent may reduce resistance to infections caused by parasites. If you already have a parasitic infection, you should be treated for it before starting treatment with Dupixent.
Talk to your doctor if you experience diarrhoea, gas, stomach discomfort, oily stools, or dehydration, which may be signs of a parasitic infection.
Talk to your doctor if you live in an area where such infections are common or if you plan to travel to such an area.

Eye problems
Inform your doctor if you notice any symptoms or worsening of eye problems, including eye pain or changes in vision.

Children and adolescents

The pre-filled pen of Dupixent is not intended for use in children under 2 years of age. For children aged 6 months to less than 2 years, contact your doctor, who will prescribe the appropriate pre-filled syringe of Dupixent.
In children aged 6 months to less than 12 years, dupilumab should be administered by a caregiver.
In children aged 12 years and older, dupilumab is recommended to be administered by or under the supervision of an adult.
The safety and benefits of Dupixent have not yet been established in children under 6 months of age with atopic dermatitis.
The safety and benefits of Dupixent have not yet been established in children under 6 years of age with asthma.
The safety and benefits of Dupixent have not yet been established in children under 18 years of age with CRSwNP.
The safety and benefits of Dupixent have not yet been established in children under 18 years of age with PN.
The safety and benefits of Dupixent have not yet been established in children under 1 year of age or with body weight < 15 kg with EoE.
The safety and benefits of Dupixent have not yet been established in children under 18 years of age with COPD.
The safety and benefits of Dupixent have not yet been established in children under 12 years of age with CSU.

Other medicines and Dupixent
Inform your doctor or pharmacist

if you are taking, have recently taken, or might take any other medicines.
if you have recently received or are scheduled to receive any vaccination.

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. The effects of this medicine in pregnant women are unknown; therefore, it is preferable to avoid using Dupixent during pregnancy unless your doctor specifically instructs you to do so.
If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine. You and your doctor will need to decide whether to breastfeed or use Dupixent. You should not do both.

Driving and using machines
It is unlikely that Dupixent will affect your ability to drive or use machines.

Dupixent contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 300 mg dose, i.e., essentially 'sodium-free'.

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