Dupixent 300 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dupixent 300 mg solution for injection in pre-filled syringe

dupilumab

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

• Keep this leaflet, as 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Dupixent is and what it is used for
2. What you need to know before using Dupixent
3. How to use Dupixent
4. Possible side effects
5. How to store Dupixent
6. 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 interleukins (IL)-4 and IL-13. Both play a key role in the development of 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 it 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 with topical eczema medications applied to the skin or may be used alone.

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

Dupixent is also used, together with other medications, for maintenance treatment of CRSwNP in adults whose disease is not controlled with their current CRSwNP medication. 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 (CNP). Dupixent may be used with topical medications for NP applied to the skin or may be used alone.

Dupixent is also used to treat adults, adolescents, and children aged 1 year and older with a minimum body weight of 15 kg with eosinophilic oesophagitis (EoE).

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

Dupixent is also used to treat adults, adolescents, and children aged 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) may improve your skin condition and reduce itching. Dupixent has also demonstrated improvement in 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 may improve your breathing ability. Dupixent may also help reduce the amount of another group of medications 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 flare-ups (exacerbations) and may improve your breathing ability. Dupixent may also help improve general COPD symptoms.

Using Dupixent for CSU may improve your 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 components of this medicine (listed in section 6).

If you think you may be allergic, or are unsure, consult your doctor, pharmacist, or nurse before using Dupixent.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Dupixent:

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

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 packaging after “Lot”) and keep this information in a safe place.

Allergic reactions

• Rarely, Dupixent may cause serious adverse reactions, including allergic reactions (hypersensitivity), anaphylactic reaction, and angioedema. These reactions may occur from minutes after administration of Dupixent up to seven days afterwards. While using Dupixent, you should watch for signs of these conditions (i.e., breathing difficulties, swelling of the face, lips, mouth, throat, or tongue, fainting, dizziness, feeling faint (low blood pressure), fever, general feeling of discomfort, swollen lymph nodes, hives, itching, joint pain, skin rash). These signs are listed under "Serious adverse reactions" in section 4.
• Stop using Dupixent and tell your doctor or seek immediate medical help if you notice any signs of an allergic reaction.

Eosinophilic conditions

• Rarely, patients taking medication for asthma may develop inflammation of blood vessels or lungs due to an increase in a certain type of 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 has been stopped or is being tapered.
• If you develop a combination of symptoms including flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms and/or rash, inform your doctor immediately.

Parasitic infection (intestinal parasites)

• Dupixent may weaken your resistance to infections caused by parasites. If you already have a parasitic infection, it should be treated before starting treatment with Dupixent.
• Consult your doctor if you have diarrhea, gas, stomach discomfort, greasy stools, or dehydration, which may be signs of a parasitic infection.
• If you live in or are traveling to an area where such infections are common, consult your doctor.

Asthma

If you have asthma and are taking medication for asthma, do not change or stop taking your asthma medication without consulting your doctor. Talk to your doctor before stopping treatment with Dupixent or if your asthma is not controlled or worsens during treatment with this medicine.

Eye problems

Talk to your doctor if you develop or experience worsening eye problems, including eye pain or changes in vision.

Children and adolescents

• The Dupixent pre-filled pen is not designed 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 Dupixent pre-filled syringe.

• 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 chronic rhinosinusitis with nasal polyps (CRSwNP).

• The safety and benefits of Dupixent have not yet been established in children under 18 years of age with prurigo nodularis (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 eosinophilic esophagitis (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 2 years of age with chronic urticaria (CU).

Other medicines and Dupixent

Tell your doctor or pharmacist

• if you are taking, have recently taken, or might need to take any other medicines.
• if you have recently been vaccinated or need to be vaccinated.

Other asthma medicines

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

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

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using 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 advises otherwise.
• If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine. You and your doctor must decide whether to breastfeed or use Dupixent. You should not do both at the same time.

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; hence, 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. Inform your doctor if you or your child has any known allergies.

3. How to use Dupixent

Follow exactly the instructions for administering this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose of 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 two weeks by 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 (every two weeks)
Less than 60 kg	400 mg (two injections of 200 mg)	200 mg
60 kg or more	600 mg (two injections of 300 mg)	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:

Patient body weight	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 the day 15 dose
60 kg or more	600 mg (two 300 mg injections)	300 mg every two weeks

• The dose may be increased to 200 mg every two weeks according to the physician's judgment.

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

For patients with severe asthma who are taking oral corticosteroids or for patients with severe asthma and comorbid moderate-to-severe atopic dermatitis or adults with comorbid severe chronic rhinosinusitis with nasal polyposis, the recommended dosage of Dupixent is:

• An initial dose of 600 mg (two injections of 300 mg)
• Followed by 300 mg administered every two weeks by subcutaneous injection.

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

• An initial dose of 400 mg (two injections of 200 mg)
• Followed by 200 mg administered every two weeks by subcutaneous injection.

Recommended dosage in children with asthma

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

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

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

Recommended dose in adults with chronic rhinosinusitis with nasal polyposis (CRSwNP)

In CRSwNP, the recommended initial dose of Dupixent is 300 mg, followed by 300 mg every two weeks by subcutaneous injection.

Recommended dose in adults with nodular prurigo (NP)

For patients with nodular prurigo, the recommended dose of Dupixent is:

• An initial dose of 600 mg (two injections of 300 mg)
• Followed by 300 mg administered every two weeks by subcutaneous injection.

Recommended dose in adults, adolescents, and children (1 year of age and older) with eosinophilic esophagitis (EoE)

Body weight	Dosage
≥15 kg to <30 kg	200 mg every two weeks
≥30 kg to <40 kg	300 mg every two weeks
≥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 administered every two weeks 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 administered every two weeks.

Recommended dose in children and adolescents aged 6 to 17 years with chronic spontaneous urticaria (CSU)

The recommended dose of Dupixent for children and adolescents (aged 6 to 17 years) with chronic spontaneous urticaria is based on body weight:*

Body weight	Initial dose	Subsequent doses
15 kg to less than 30 kg	300 mg (one 300 mg injection) on day 1, followed by 300 mg on day 15	300 mg every 4 weeks (Q4W), starting 4 weeks after the day 15 dose
30 kg to less than 60 kg	400 mg (two 200 mg injections)	200 mg every two weeks (Q2W)
60 kg or more	600 mg (two 300 mg injections)	300 mg every two weeks (Q2W)

*For patients weighing from 5 kg to less than 15 kg, the recommended dose is 200 mg every 4 weeks (Q4W).

Recommended dose in children 2 to 5 years of age 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 dose
5 kg to less than 15 kg	200 mg every four weeks (E4W)
15 kg to less than 30 kg	300 mg every four weeks (E4W)

Dupixent Injection

Dupixent is administered by injection under the skin (subcutaneous injection). You and your doctor or nurse should decide whether you should self-inject Dupixent.

Before self-injecting Dupixent, you must be properly trained by your doctor or nurse. Your Dupixent injection may also be administered by a caregiver after appropriate training by a healthcare professional. Each pre-filled pen contains one dose of Dupixent (300 mg). Do not shake the pre-filled pen. Carefully read 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 if you have administered the dose too early, consult your doctor, pharmacist, or nurse.

If you forget to use Dupixent

If you forget to inject a dose of Dupixent, consult your doctor, pharmacist, or nurse.

In addition,

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

• administer the Dupixent injection as soon as possible, and start a new weekly dosing schedule from the day you remember to take your missed injection.

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

• administer the Dupixent injection within 7 days of the missed dose, then resume your original schedule.
• if the missed dose is not administered within 7 days, wait until your next scheduled dose to administer your Dupixent injection.

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

• administer the Dupixent injection within 7 days of the missed dose, then resume your original schedule.
• if the missed dose is not administered within 7 days, start a new dosing schedule every 4 weeks from the day you remember to take your missed injection.

If you stop treatment with Dupixent

Do not stop treatment with Dupixent without first discussing it with your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Dupixent may cause serious adverse effects, including rare allergic reactions (hypersensitivity), such as 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 faint (low blood pressure)
• fever
• feeling generally unwell
• swollen lymph nodes
• hives
• itching
• joint pain
• skin rash

If you develop an allergic reaction, stop using Dupixent and contact your doctor immediately.

Other adverse effects

Frequent (may affect up to 1 in 10 people):

• injection site reactions (e.g., localized redness, swelling, itching, pain, bruising)
• red and itchy eyes
• eye infection
• herpes (of the lips and skin)
• an 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):

• serious allergic reactions (hypersensitivity)
• ulcers on the clear outer layer of the eye, sometimes with blurred vision (ulcerative keratitis)

Additional adverse effects in children aged 6 to 11 years with asthma

Frequent: pinworm infection (enterobiasis)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 after EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 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 at room temperature up to 25 °C for a maximum of 14 days, protected from light. The date when it was removed from the refrigerator must be recorded in the space provided for this purpose on the outer carton. The carton must be discarded if the syringe has been kept 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, discolored, or contains particles.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dupixent

• The active substance is dupilumab.
• Each pre-filled pen contains 300 mg of dupilumab in 2 ml of injectable solution.
• The other components are L-arginine monohydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 (E 433), sodium acetate trihydrate, glacial acetic acid (E 260), sucrose, and water for injections.

Description of the product 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 an oval viewing window surrounded by an arrow, or a square-edged cap and an oval viewing window without an arrow. Although there are minor differences in the appearance of the two pre-filled pens, both function identically.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer

SANOFI WINTHROP INDUSTRIE

1051 Boulevard Industriel,

76580 LE TRAIT,

France

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

Industriepark Hoechst

65926 FRANKFURT AM MAIN

Germany

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Sanofi Belgium Tel/Tel: +32 (0)2 710 54 00	Lithuania Swixx Biopharma UAB Tel: +370 5 236 91 40
	Luxembourg/Luxembourg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgium/Belgium)
Czech Republic Sanofi s.r.o. Tel: +420 233 086 111	Hungary SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0050
Denmark Sanofi A/S Tlf: +45 45 16 70 00	Malta Sanofi S.r.l. Tel: +39 02 39394275
Germany Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 996 Tel. from abroad: +49 69 305 70 13	Netherlands Sanofi B.V. Tel: +31 20 245 4000
Estonia Swixx Biopharma OÜ Tel: +372 640 10 30	Norway sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Greece Sanofi-Aventis Μονοπρόσωπη AEBE Tel: +30 210 900 16 00	Austria sanofi-aventis GmbH Tel: +43 1 80 185 – 0
Spain sanofi-aventis, S.A. Tel: +34 93 485 94 00	Poland Sanofi Sp. z o.o. Tel.: +48 22 280 00 00
France Sanofi Winthrop Industrie Tél: 0 800 222 555 Call from abroad: +33 1 57 63 23 23	Portugal Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400
Croatia Swixx Biopharma d.o.o. Tel: +385 1 2078 500	Romania 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	Slovenia Swixx Biopharma d.o.o. Tel: +386 1 235 51 00
Iceland Vistor ehf. Sími: +354 535 7000	Slovakia Swixx Biopharma s.r.o. Tel: +421 2 208 33 600
Italy Sanofi S.r.l. Tel: 800 536389	Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300
Cyprus C.A. Papaellinas Ltd. Tel: +357 22 741741	Sweden Sanofi AB Tel: +46 (0)8 634 50 00
Latvia Swixx Biopharma SIA Tel: +371 6 616 47 50

Date of the latest review of this leaflet:

Other sources of information

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

---

Dupixent 300mg solution for injection in pre-filled pen

dupilumab

Instructions for use

The drawing below shows the parts of the Dupixent pre-filled pen.

Important information

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

Do not attempt to administer the injection to yourself or another person unless you have been trained by your healthcare professional. 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. The Dupixent pre-filled pen is intended for use only in adults and children aged 2 years and older.

• Read all instructions carefully before using the pre-filled pen.
• Ask your healthcare professional how often the medicine should be injected.
• 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 green cap is missing or not properly attached.
• Do not press or touch the yellow needle shield with your fingers.
• Do not inject through clothing.
• Do not remove the green cap until just before administering the injection.
• Do not attempt to re-cap the green cap onto the pre-filled pen.
• Do not reuse the pre-filled pen.

Storage of Dupixent

• Keep the pre-filled pen(s) and all medicines out of the reach of children.
• Keep unused pre-filled pens in their original packaging and store them in the refrigerator at 2 °C to 8 °C.
• Store pre-filled pens in their original packaging to protect them from light.
• Do not keep pre-filled pens at room temperature (<25 °C) for more than 14 days. If you need to remove the packaging from the refrigerator permanently, write the date of removal in the space provided on the outer carton, and use Dupixent within the following 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 expose the pre-filled pen to direct sunlight.

A: Prepare

A1. Prepare the necessary materials

Make sure you have the following:

• the Dupixent pre-filled pen
• 1 alcohol swab*
• 1 cotton ball or gauze*
• a sharps disposal container* (see Step D)

*Items not included in the package

A2. Check the label

• Confirm that you have the correct medicine and dose.

A3. Check the expiration date

• Check the expiration date.

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

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

A4. Check the medicine

Look at the medicine through the viewing window of the pre-filled pen.

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

Note: An air bubble may be visible, which is normal.

Do not use the pre-filled pen if the liquid is cloudy or discoloured, or if it contains flakes or visible particles.

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

A5. Wait 45 minutes

Place the pre-filled pen on a flat surface and allow it to warm naturally to room temperature (below 25 °C) for at least 45 minutes.

Do not heat the pre-filled pen in a microwave, hot water, or direct sunlight.

Do not place the pre-filled pen in direct sunlight.

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

• Choose the injection site

B1. Recommended injection sites are:

• Thigh.
• Stomach, avoiding the area within approximately 5 cm around your navel.
• Upper arm. If a caregiver is administering your dose, the outer area of the upper arm may also be used.

Choose a different injection site for each Dupixent injection.

Do not inject through clothing.

Do not administer the injection into sensitive, damaged, bruised, or scarred skin.

B2. Wash hands

B3. Prepare the injection site

• Clean the injection site with an alcohol swab.
• Allow the skin to dry before proceeding with the injection.

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

• Administer the injection

C1. Remove the green cap

Pull the green cap straight off.

Do not twist the green cap.

Do not remove the green cap until you are ready to inject.

Do not press or touch the yellow needle shield with your fingers. The needle is inside.

Do not re-cap the green cap onto the pre-filled pen after removal.

C2. Pinch the skin and position

• Pinch the skin before and during the injection.

• Pinching is not required in adults and children aged 12 years and older.

• When placing the yellow needle shield on your skin, hold the pre-filled pen so that you can see the viewing window.

• Place the yellow needle shield on your skin at an angle of approximately 90 degrees.

Do not press or touch the yellow needle shield with your fingers. The needle is inside.

C3. Press down

Press the pre-filled pen firmly against your skin until you can no longer see the yellow needle shield, and hold it in place.

• You will hear a "click" when the injection starts.
• The viewing window will begin to turn yellow.

The injection may take up to 20 seconds.

Pinching the skin is not required in adults and children aged 12 years and older.

C4. Hold firmly

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

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

If the window does not turn completely yellow, remove the pen and contact your healthcare professional.

Do not administer a second dose without speaking to your healthcare professional.

Pinching the skin is not required in adults and children aged 12 years and older.

C5. Remove

• After your injection is complete, pull straight up to remove the pre-filled pen from the skin and dispose of it immediately as described in Section D.

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

Do not rub the skin after administering the injection.

• Disposal

• Immediately after use, dispose of the pre-filled pens (with needle inside) and green caps into a sharps disposal container.

Do not dispose of (throw away) the pre-filled pens (with needle inside) or green caps in household waste.

Do not re-cap the green cap.

Dupixent 300mg solution for injection in pre-filled pen

dupilumab

Instructions for use

The drawing below shows the parts of the Dupixent pre-filled pen.

Important information

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

Do not attempt to administer the injection to yourself or another person unless you have been trained by your healthcare professional. 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. The Dupixent pre-filled pen is intended for use only in adults and children aged 2 years and older.

• Read all instructions carefully before using the pre-filled pen.
• Ask your healthcare professional how often the medicine should be injected.
• 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 green cap is missing or not properly attached.
• Do not press or touch the yellow needle shield with your fingers.
• Do not inject through clothing.
• Do not remove the green cap until just before administering the injection.
• Do not attempt to re-cap the green cap onto the pre-filled pen.
• Do not reuse the pre-filled pen.

Storage of Dupixent

• Keep the pre-filled pen(s) and all medicines out of the reach of children.
• Keep unused pre-filled pens in their original packaging and store them in the refrigerator at 2 °C to 8 °C.
• Store pre-filled pens in their original packaging to protect them from light.
• Do not keep pre-filled pens at room temperature (<25 °C) for more than 14 days. If you need to remove the packaging from the refrigerator permanently, write the date of removal in the space provided on the outer carton, and use Dupixent within the following 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 expose the pre-filled pen to direct sunlight.

A: Prepare

A1. Prepare the necessary materials

Make sure you have the following:

• the Dupixent pre-filled pen
• 1 alcohol swab*
• 1 cotton ball or gauze*
• a sharps disposal container* (see Step D)

*Items not included in the package

A2. Check the label

• Confirm that you have the correct medicine and dose.

A3. Check the expiration date

• Check the expiration date.

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

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

A4. Check the medicine

Look at the medicine through the viewing window of the pre-filled pen.

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

Note: An air bubble may be visible, which is normal.

Do not use the pre-filled pen if the liquid is cloudy or discoloured, or if it contains flakes or visible particles.

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

A5. Wait 45 minutes

Place the pre-filled pen on a flat surface and allow it to warm naturally to room temperature (below 25 °C) for at least 45 minutes.

Do not heat the pre-filled pen in a microwave, hot water, or direct sunlight.

Do not place the pre-filled pen in direct sunlight.

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

• Choose the injection site

B1. Recommended injection sites are:

• Thigh.
• Stomach, avoiding the area within approximately 5 cm around your navel.
• Upper arm. If a caregiver is administering your dose, the outer area of the upper arm may also be used.

Choose a different injection site for each Dupixent injection.

Do not inject through clothing.

Do not administer the injection into sensitive, damaged, bruised, or scarred skin.

B2. Wash hands

B3. Prepare the injection site

• Clean the injection site with an alcohol swab.
• Allow the skin to dry before proceeding with the injection.

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

• Administer the injection

C1. Remove the green cap

Pull the green cap straight off.

Do not twist the green cap.

Do not remove the green cap until you are ready to inject.

Do not press or touch the yellow needle shield with your fingers. The needle is inside.

Do not re-cap the green cap onto the pre-filled pen after removal.

C2. Pinch the skin and position

• Pinch the skin before and during the injection.
• Pinching is not required in adults and children aged 12 years and older.
• When placing the yellow needle shield on your skin, hold the pre-filled pen so that you can see the viewing window.
• Place the yellow needle shield on your skin at an angle of approximately 90 degrees.

Do not press or touch the yellow needle shield with your fingers. The needle is inside.

C3. Press down

Press the pre-filled pen firmly against your skin until you can no longer see the yellow needle shield, and hold it in place.

• You will hear a "click" when the injection starts.
• The viewing window will begin to turn yellow.

The injection may take up to 15 seconds.

Pinching the skin is not required in adults and children aged 12 years and older.

C4. Hold firmly

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

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

If the window does not turn completely yellow, remove the pen and contact your healthcare professional.

Do not administer a second dose without speaking to your healthcare professional.

Pinching the skin is not required in adults and children aged 12 years and older.

C5. Remove

• After your injection is complete, pull straight up to remove the pre-filled pen from the skin and dispose of it immediately as described in Section D.

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

Do not rub the skin after administering the injection.

• Disposal

• Immediately after use, dispose of the pre-filled pens (with needle inside) and green caps into a sharps disposal container.

Do not dispose of (throw away) the pre-filled pens (with needle inside) or green caps in household waste.

Do not re-cap the green cap.