Label: information for the user

Dupixent 300 mg injectable solution in pre-filled pen

dupilumab

Read this label carefully before starting to use this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this label. See section 4.

What is Dupixent

Dupixent contains the active ingredient dupilumab.

Dupilumab is a monoclonal antibody (a type of specialized protein) that blocks the action of proteins called interleukins (IL)-4 and IL-13. Both play a key role in the appearance of symptoms and signs of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), nodular prurigo (NP), eosinophilic esophagitis (EoE), and chronic obstructive pulmonary disease (COPD).

Indications

Dupixent is used to treat adults and adolescents12 years and olderwith moderate to severe atopic dermatitis, also known as eczema. Dupixent is also used to treat children 6 months to 11 years with severe atopic dermatitis (see sectionChildren and adolescents). Dupixent can be used with topical medications for eczema or alone.

Dupixent is also used, along with other asthma medications, for themaintenance treatmentof severe asthma in adults, adolescents, and children6 years and olderwhose asthma is not controlled with their current medication (e.g., corticosteroids).

Dupixent is also used, along with other medications, for the maintenance treatment ofCRSwNP in adults whose disease is not controlled with their current medication for CRSwNP. Dupixent can also reduce the need for surgery and the need for systemic corticosteroids.

Dupixent is also used to treat adults with nodular prurigo (NP) of moderate to severe, also known as chronic nodular prurigo (CNP). Dupixent can be used with topical medications for NP or alone.

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

Dupixent is also used, along with other medications, for the maintenance treatment ofchronic obstructive pulmonary disease (COPD) in adults with uncontrolled COPD.

How Dupixent works

The use of Dupixent for atopic dermatitis (eczema) may improve your skin condition and reduce itching. Dupixent has also shown improvement in symptoms of pain, anxiety, and depression associated with atopic dermatitis. Additionally, Dupixent helps to improve sleep disorders and overall quality of life.

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

Dupixent helps to prevent moderate or severe COPD exacerbations and may improve lung function. Dupixent can also help to improve overall COPD symptoms.

No use Dupixent

• if you are allergic to dupilumab or any of the other ingredients in this medicine (listed in section 6).

If you think you may be allergic, or are not sure,consult your doctor, pharmacist or nurse before using Dupixent.

Warnings and precautions

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

Dupixentis not a rescue medicineand should not be used to treat a sudden asthma attack or COPD exacerbation.

Each time you have a new pack of Dupixent, it is important to note the name of the medicine, the date of administration and the batch number (which can be found on the pack after “Batch”) and keep this information in a safe place.

Allergic reactions

• Very rarely, Dupixent can cause serious side effects, including allergic reactions (hypersensitivity), anaphylactic reaction and angioedema. These reactions can occur from minutes after administration of Dupixent up to seven days after the same. While using Dupixent, you should observe the signs of these diseases (i.e. respiratory problems, swelling of the face, lips, mouth, throat or tongue, dizziness, drowsiness, feeling of low blood pressure, fever, feeling of general discomfort, lymph node inflammation, hives, itching, joint pain, skin rash). These signs are listed in “Serious side effects” in section 4.
• Stop using Dupixent and tell your doctor or get medical help immediately if you notice any sign of an allergic reaction.

Eosinophilic diseases

• Rarely, patients taking an asthma medicine may develop inflammation of the blood vessels or lungs due to an increase in a certain type of white blood cell (eosinophilia).
• It is not known if 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 whose dose is being reduced.
• If you experience a combination of symptoms that includes a flu-like illness, tingling or numbness in the arms or legs, worsening of lung symptoms and/or rash, report this to your doctor immediately.

Intestinal parasitic infection

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

Asthma

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

Eye problems

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

Children and adolescents

• The pre-filled pen of Dupixent is not designed for usein children under 2 years of age.
• For children from 6 months to less than 2 years of age, contact your doctor, who will prescribe the appropriate Dupixent pre-filled syringe.
• In children from 6 months to less than 12 years of age, dupilumab should be administered by a caregiver.
• In children 12 years of age and older, dupilumab should be administered by or under the supervision of an adult.

• The safety and benefits of Dupixent in children under 6 months of age with atopic dermatitis are not yet known.
• The safety and benefits of Dupixent in children under 6 years of age with asthma are not yet known.
• The safety and benefits of Dupixent in children under 18 years of agewithCSUCPN are not yet known.
• The safety and benefits of Dupixent in children under 18 years of agewithPNE are not yet known.

• The safety and benefits of Dupixent in children under 1 year of age, or with a body weight <15>withEEo are not yet known.
• The safety and benefits of Dupixent in children under 18 years of agewithCOPD are not yet known.

Other medicines and Dupixent

Inform your doctor or pharmacist

• if you are using, have used recently or may need to use any other medicine.
• if you have been recently vaccinated or need to be vaccinated.

Other asthma medicines

Do not interrupt or reduce your asthma medication, unless your doctor tells you to.

• These medicines (especially those called corticosteroids) should be tapered off.
• 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 intend to become pregnant, consult your doctor before using this medicine. The effects of this medicine on pregnant women are unknown; therefore, it is best to avoid using Dupixent during pregnancy unless your doctor advises you to do so.
• If you are breastfeeding or intend to breastfeed, consult your doctor before using this medicine. You and your doctor should decide whether to breastfeed or use Dupixent. Do not do both at the same time.

Driving and operating machines

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

Dupixent contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 300 mg dose; this is, 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 have or your child has any known allergy.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

What dose of Dupixent you will receive

Your doctor will decide what dose of Dupixent is suitable for you.

Recommended dose in adults with atopic dermatitis

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

Recommended dose in children 6 to 11 years old with atopic dermatitis

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

* The dose can be increased to 200 mg every two weeks as per doctor's opinion.

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

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

Recommended dose in adults and adolescents with asthma (from 12 years old)

For patients with severe asthma and takingcorticosteroidsorally or for patients with severe asthma and moderate to severe comorbid atopic dermatitis or adults withchronic rhinosinusitis with nasal polyps, the recommended dose of Dupixent is:

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

For the rest of 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 two weeks by subcutaneous injection.

Recommended dose in children with asthma

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

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

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

InCRSwNP,the first recommended dose of Dupixent is 300 mg followed by 300 mg every two weeks by subcutaneous injection.

Recommended dose in adults with prurigo nodularis (PN)

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

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

Recommended dose in adults, adolescents, and children (from 1 year old) with eosinophilic esophagitis (EoE)

Recommended dose in adults with chronic obstructive pulmonary disease (COPD)

In COPD, the recommended dose of Dupixent is 300 mgadministered every two weeksby subcutaneous injection.

Dupixent injection

Dupixent is administered by subcutaneous injection under your skin. 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 can also be administered by a caregiver after proper training by a doctor or nurse.

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

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

If you use more Dupixent than you should

If you use more Dupixent than you should or have administered the dose too soon, consult your doctor, pharmacist, or nurse.

If you forget to use Dupixent

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

Additionally,

If your dosing schedule isevery weekand you forget a dose of Dupixent:

• administer the Dupixent injection as soon as possible and start a new dosing schedule every week from the time you remember to administer your Dupixent injection.

If your dosing schedule isevery two weeksand you forget a dose of Dupixent:

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

If yourdosingschedule isevery 4 weeksand you forget a dose of Dupixent:

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

If you interrupt Dupixent treatment

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

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

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

Dupixent can cause serious side effects, including rare allergic reactions (hypersensitivity), including anaphylactic reaction, serum sickness, type of serum sickness reaction; symptoms may include:

• respiratory problems
• swelling of the face, lips, mouth, throat, or tongue (angioedema)
• dizziness, dizziness, feeling of dizziness (low blood pressure)
• fever
• general feeling of discomfort
• inflammation of lymph nodes
• itching
• itching
• joint pain
• skin rash

If you develop an allergic reaction, stop using Dupixent andconsultyour doctor immediately.

Other side effects

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

• reactions at the injection site (e.g., localized redness, swelling, itching, pain, hematomas)
• redness and itching of the eyes
• eye infection
• herpes (on the lips and skin)
• an increase in a certain number of white blood cells (eosinophils)
• joint pain (arthritis)

Uncommon(may affect up to 1 in 100 people):

• swelling of the face, lips, mouth, throat, or tongue (angioedema)
• itching, redness, and swelling of eyelids
• inflammation of the surface of the eye, sometimes with blurred vision (keratitis)
• skin rash or redness
• dry eyes

Rare(may affect up to 1 in 10,000 people):

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

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

Common: pinworms (enterobiasis)

Reporting side effects

If you experience any type of side effect, consult your doctor,pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughthe national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label and the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C). Do not freeze. Store in the original packaging to protect it from light.

If necessary, the preloaded pen can be removed from the refrigerator and stored in the packaging for a maximum of 14 days at room temperature up to 25°C, protected from light. The date when it is removed from the refrigerator will be noted in the space provided for this purpose on the outer packaging.The packaging must be discarded if it is left out of the refrigerator for more than 14 days or if the expiration date has passed.

Do not use this medication if you observe that the medication is cloudy, discolored, or contains particles.

Medications should not be thrown away through the drains or in the trash. Ask your doctor, pharmacist, or nurse how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Dupixent

• The active ingredient is dupilumab.
• Each pre-filled syringe contains 300 mg of dupilumab in 2 ml of injectable solution (injectable).
• The other components are L-Arginine monohydrochloride, L-Histidine, L-Histidine monohydrochloride monohydrate, polisorbate 80 (E 433), sodium acetate trihydrate, glacial acetic acid (E 260), sucrose, and water for injectable preparations.

Appearance of the product and contents of the package

Dupixent is a transparent to slightly opalescent, colorless to pale yellow solution that is presented in a pre-filled syringe.

The pre-filled syringe may either have a round cap and an oval-shaped viewing window surrounded by an arrow, or it may have a square cap with rounded edges and an oval-shaped viewing window without an arrow. Although there are small differences in the appearance of the two pre-filled syringes, both function equally.

Dupixent is available as pre-filled syringes of 300 mg in a package containing 1, 2, or 6 pre-filled syringes or in a package containing 6 (2 packages of 3) pre-filled syringes.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Responsible for manufacturing

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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Date of the last review of this leaflet:

Other sources of information

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

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Dupixent 300mg solution for injection in pre-filled syringe

dupilumab

Instructions for use

In this drawing, the parts of the pre-filled syringe of Dupixent are shown.

Important information

This device is a single-use pre-filled syringe. It contains 300mg of Dupixent for subcutaneous injection.

Do not attempt to administer the injection to yourself or to another person, unless you have received training from your healthcare professional. In adolescents aged 12 years and older, it is recommended that Dupixent be administered by or under the supervision of an adult. In children under 12 years of age, Dupixent should be administered by a caregiver. The pre-filled syringe of Dupixent is only for use in adults and children aged 2 years and older.

• Read all the instructions carefully before using the pre-filled syringe.
• 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 syringe if it has been damaged.
• Do not use the pre-filled syringe if the green cap is missing or not properly attached.
• Do not press or touch the yellow cap of the needle with your fingers.
• Do not inject through clothing.
• Do not remove the green cap until just before the injection is administered.
• Do not attempt to put the green cap back on the pre-filled syringe after it has been removed.
• Do not reuse the pre-filled syringe.

Storage of Dupixent

• Keep the pre-filled syringes and all medicines out of the reach of children.
• Keep unused pre-filled syringes in the original packaging and store them in the refrigerator between 2°C and 8°C.
• Store pre-filled syringes in the original packaging to protect them from light.
• Do not store pre-filled syringes at room temperature (<25°C) for more than 14days. If you need to remove the packaging from the refrigerator permanently, write the date you remove it in the space provided on the outer packaging, and use Dupixent within 14days.
• Do not shake the pre-filled syringe at any time.
• Do not heat the pre-filled syringe.
• Do not freeze the pre-filled syringe.
• Do not expose the pre-filled syringe to direct sunlight.

A: Prepare

A1. Prepare the necessary materials

Ensure that you have the following:

• the pre-filled syringe of Dupixent
• 1 alcohol wipe*
• 1 cotton ball or gauze*
• a sharps container* (see Step D)

*Items not included in the packaging

A2. Check the label

• Confirm that you have the correct medicine and dosage.

A3. Check the expiration date

• Check the expiration date.

Do not use the pre-filled syringe 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 syringe.

Check that the liquid is transparent and colorless to pale yellow.

Note: you may see a bubble of air, but this is normal.

Do not use the pre-filled syringe if the liquid is cloudy or discolored, or if it contains visible lumps or particles.

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

A5. Wait 45 minutes

Place the pre-filled syringe on a flat surface and let it come to room temperature (less than 25°C) for at least 45 minutes.

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

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

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

B. Choose the injection site

B1. Recommended injection sites are:

• Thigh.
• Abdomenavoiding the area within 5 cm of your navel.
• Upper arm.If a caregiver is administering your dose, you can also use the outer area of the upper arm.

Choose a different injection site for each injection of Dupixent.

Do not inject through clothing.

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

B2. Wash your hands

B3. Prepare the injection site

• Disinfect the injection site with an alcohol wipe.
• Allow the skin to dry before proceeding with the injection.

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

C. Administer the injection

C1. Remove the green cap

Remove the green cap by pulling it straight off.

Do not twist the green cap.

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

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

Do not attempt to put the green cap back on the pre-filled syringe after it has been removed.

C2. Pinch the skin and place

• Pinch the skin before and during the injection.
• You do not need to pinch the skin in adults and children aged 12 years and older.
• When you place the yellow cap of the needle on your skin, hold the pre-filled syringe in a way that allows you to see the viewing window.
• Place the yellow cap of the needle on your skin at an angle of approximately 90 degrees.

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

C3. Press down

Press the pre-filled syringe firmly against your skin until you cannot see the yellow cap of the needle and keep it that way.

• 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.

You do not need to pinch the skin in adults and children aged 12 years and older.

C4. Hold firmly

Continue to hold the pre-filled syringe firmly against your skin.

• You may hear a second click.
• Check that the entire viewing window has turned yellow.
• Then count slowly to 5.
• After that, lift the pre-filled syringe off your skin,your injection is complete.

If the viewing window does not turn completely yellow, remove the pre-filled syringe and call your healthcare professional.

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

You do not need to pinch the skin in adults and children aged 12 years and older.

C5. Remove

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

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

Do not rub the skin after the injection.

D. Dispose

• Dispose of the pre-filled syringes, (needle inside), and green caps in a sharps container immediately after use.

Do not dispose of (throw away) the pre-filled syringes, (needle inside), and green caps in the trash.

Do not put the green cap back on.