DUPIXENT 200 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Introduction

Package Leaflet: Information for the User

Dupixent 200 mg solution for injection in pre-filled pen

dupilumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dupixent and what is it used for
2. What you need to know before you use Dupixent
3. How to use Dupixent
4. Possible side effects
5. Storing Dupixent
6. Contents of the pack and other information

1. What is Dupixent and what is it used for

What is Dupixent

Dupixent contains the active substance dupilumab.

Dupilumab is a monoclonal antibody (a special type of protein) that blocks the action of proteins called interleukins (IL)-4 and IL-13. Both play a key role in the appearance of signs and symptoms of atopic dermatitis and asthma.

What is it used for

Dupixent is used to treat adults and adolescents from 12 years of age 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 can be used with medicines for eczema that are applied to the skin or can be used alone.

Dupixent is also used, along with other asthma medicines, for the maintenance treatment of severe asthma in adults, adolescents, and children from 6 years of age whose asthma is not controlled with their current medication (e.g., corticosteroids).

How Dupixent works

Using Dupixent for atopic dermatitis (atopic eczema) may improve your skin disease and reduce itching. Dupixent has also shown an improvement in symptoms of pain, anxiety, and depression associated with atopic dermatitis. Additionally, Dupixent helps improve sleep disorders and your 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 medicines you need to control your asthma, called oral corticosteroids, while preventing severe asthma attacks and improving your breathing ability.

2. What you need to know before you use Dupixent

Do not use Dupixent

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 Dupixent:

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

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

Allergic reactions

• 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 to seven days after administration. While using Dupixent, you should watch for signs of these diseases (i.e., respiratory problems, swelling of the face, lips, mouth, throat, or tongue, fainting, dizziness, feeling of dizziness (low blood pressure), fever, feeling of general discomfort, inflammation of the lymph nodes, 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 as a result of 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 discontinued or is being reduced in dose.
• If you experience a combination of symptoms that include a flu-like illness, tingling or numbness of the 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 upset, greasy stools, and dehydration that may be a sign of a parasitic infection.
• If you live in a region where these infections are frequent or if you are traveling to that region, 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 treatment with Dupixent or if your asthma is not controlled or worsens during treatment with this medicine.

Eye problems

Consult your doctor if eye problems appear or worsen, 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 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 from 12 years of age, it is recommended that dupilumab 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.

Other medicines and Dupixent

Tell your doctor or pharmacist

Other asthma medicines

Do not stop or reduce your asthma medicines unless your doctor tells you to.

• These medicines (especially those called 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 plan to become pregnant, consult your doctor before using this medicine. The effects of this medicine in pregnant women are not known; therefore, it is preferable to avoid using Dupixent during pregnancy unless your doctor advises you to do so.
• If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine. Your doctor and you 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 and use machines.

Dupixent contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 200 mg dose; this is essentially "sodium-free".

Dupixent contains polysorbate

This medicine contains 2.28 mg of polysorbate 80 in each 200 mg dose (1.14 ml). Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergies.

3. How to use Dupixent

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in 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 adolescents with atopic dermatitis

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

Recommended dose in children from 6 to 11 years of age with atopic dermatitis

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

• The dose may be increased to 200 mg every 2 weeks according to the doctor's opinion.

Recommended dose in children from 6 months to 5 years of age with atopic dermatitis

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

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

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

• An initial dose of 400 mg (two 200 mg injections)
• Followed by 200 mg every 2 weeks administered by subcutaneous injection.

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

• An initial dose of 600 mg (two 300 mg injections)
• Followed by 300 mg administered every 2 weeks by subcutaneous injection.

Recommended dose in children with asthma

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

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

Dupixent injection

Dupixent is administered by injection under your skin (subcutaneous injection). You and your doctor or nurse should decide if you should inject Dupixent yourself.

Before injecting Dupixent yourself, you must have been properly trained by your doctor or nurse. Your Dupixent injection can also be administered by a caregiver after proper training by a doctor or nurse. Each pre-filled pen contains a dose of Dupixent (200 mg). Do not shake the pre-filled pen. Read the "Instructions for Use" carefully 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 have been 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 is every weekand you miss a dose of Dupixent:

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

If your dosing schedule is every 2 weeksand you miss a dose of Dupixent:

• administer the Dupixent injection within 7 days of the missed dose, then follow your original schedule.

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

• administer the Dupixent injection within 7 days of the missed dose, then follow your original schedule.

If you stop treatment with Dupixent

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Dupixent may cause serious side effects, including rare allergic reactions (hypersensitivity), including anaphylactic reaction, serum sickness, serum sickness-like reaction; the signs may include:

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

If you develop an allergic reaction, stop using Dupixent and consult your 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, bruising)
• 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 (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 side effects in children from 6 to 11 years of age with asthma

Common: worms (enterobiasis)

Reporting of side effects

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

5. Storing Dupixent

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the pre-filled pen in the original package to protect it from light.

If necessary, the pre-filled pen can be removed from the refrigerator and stored in the carton at room temperature up to 25°C for a maximum of 14 days. The date it is removed from the refrigerator will be noted on the space provided on the outer carton. The carton should be discarded if it is left out of the refrigerator for more than 14 days or if it has passed the expiry date.

Do not use this medicine if you notice that the medicine 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 medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Dupixent Composition

• The active ingredient is dupilumab.
• Each pre-filled pen contains 200 mg of dupilumab in 1.14 ml of injectable solution (injectable).
• 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 injectable preparations.

Product Appearance and Container Contents

Dupixent is a clear to slightly opalescent, colorless to pale yellow solution presented 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 it may have a square cap with edges and an oval viewing window without an arrow. Although there are small differences in the appearance of the two pre-filled pens, both function equally.

Dupixent is available as 200 mg pre-filled pens in a container containing 1, 2, or 6 pre-filled pens or in a container containing 6 (2 packs of 3) pre-filled pens.

Only some 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Other sources of information

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

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Dupixent 200 mg solution for injection in pre-filled pen

dupilumab

Instructions for use

This drawing shows the parts of the Dupixent pre-filled pen.

Important information

This device is a single-use pre-filled pen. It contains 200 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 from 12 years of age, 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 Dupixent pre-filled pen is for use in adults and children over 2 years of age only.

• Read all instructions carefully before using the pre-filled pen.
• Ask your healthcare professional how often you should inject the medication.
• Choose a different injection site for each injection.
• Do notuse the pre-filled pen if it has been damaged.
• Do notuse the pre-filled pen if the yellow cap is missing or not properly secured.
• Do notpress or touch the orange needle shield with your fingers. The needle is inside.
• Do notinject through clothing.
• Do notremove the yellow cap until you are ready to inject.
• Do notattempt to put the yellow cap back on the pre-filled pen.
• Do notreuse the pre-filled pen.

Storage of Dupixent

• Keep the pre-filled pen(s) and all medications out of the reach of children.
• Keep unused pre-filled pens in the original container and store them in the refrigerator between 2 °C and 8 °C.
• Keep pre-filled pens in the original container to protect them from light.
• Do notstore pre-filled pens at room temperature (<25 °C) for more than 14 days. If you need to remove the container from the refrigerator permanently, write the date you removed it on the space provided on the outer container, and use Dupixent within 14 days.
• Do notshake the pre-filled pen at any time.
• Do notheat the pre-filled pen.
• Do notfreeze the pre-filled pen.
• Do notexpose 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 container* (see Step D)

• Items not included in the container

A2. Check the label

• Confirm that you have the correct medication 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 medication

Look at the medication through the pre-filled pen window.

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

Note: You may see an air bubble, but this is normal.

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

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

A5. Wait 30 minutes

Place the pre-filled pen on a flat surface and let it warm up to room temperature (less than 25 °C) for at least 30 minutes.

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

Do not expose the pre-filled pen to direct sunlight.

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

• Choose the injection site

B1. Recommended injection sites are:

• Thigh.
• Stomachavoiding the area around the navel.
• Upper arm.If a caregiver is administering your dose, they can also use the outer aspect of the upper arm.

Choose a different injection site for each Dupixent injection.

Do not inject through clothing.

Do not inject into sensitive, damaged, or scarred skin.

B2. Wash your hands

B3. Prepare the injection site

• Clean the injection site with an alcohol swab.
• Let the skin 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 yellow cap

Pull the yellow cap straight off.

Do nottwist the yellow cap.

Do notremove the yellow cap until you are ready to inject.

Do notpress or touch the orange needle shield with your fingers. The needle is inside.

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

C2. Pinch the skin and place

• Pinch the skin before and during the injection.
• No pinching is necessary in adults and children over 12 years of age.
• When placing the orange needle shield on your skin, hold the pre-filled pen so that you can see the window.
• Place the orange needle shield on your skin at an angle of approximately 90 degrees.

Do not press or touch the orange 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 orange needle shield and hold it there.

• There will be a "click" when the injection starts.
• The window will begin to turn yellow.

The injection may take up to 20 seconds.

No pinching is necessary in adults and children over 12 years of age.

C4. Hold firmly

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

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

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

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

No pinching is necessary in adults and children over 12 years of age.

C5. Remove

• After your injection is complete, pull the pre-filled pen straight up to remove it from your skin and dispose of it immediately as described in the section D.
• If you see a little blood at the injection site, gently press a cotton ball or gauze.

Do not rub your skin after the injection.

• Dispose of

• Throw away the pre-filled pens (needle inside) and yellow caps in a sharps container immediately after use.

Do notthrow away the pre-filled pens (needle inside) and yellow caps in the trash.

Do not put the yellow cap back on.

Dupixent 200 mg solution for injection in pre-filled pen

dupilumab

Instructions for use

This drawing shows the parts of the Dupixent pre-filled pen.

Important information

This device is a single-use pre-filled pen. It contains 200 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 from 12 years of age, 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 Dupixent pre-filled pen is for use in adults and children over 2 years of age only.

• Read all instructions carefully before using the pre-filled pen.
• Ask your healthcare professional how often you should inject the medication.
• Choose a different injection site for each injection.
• Do notuse the pre-filled pen if it has been damaged.
• Do notuse the pre-filled pen if the yellow cap is missing or not properly secured.
• Do notpress or touch the orange needle shield with your fingers.
• Do notinject through clothing.
• Do notremove the yellow cap until you are ready to inject.
• Do notattempt to put the yellow cap back on the pre-filled pen.
• Do notreuse 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 the original container and store them in the refrigerator between 2 °C and 8 °C.
• Keep pre-filled pens in the original container to protect them from light.
• Do notkeep pre-filled pens at room temperature (<25 °C) for more than 14 days. If you need to remove the container from the refrigerator permanently, write the date you removed it on the space provided on the outer container, and use Dupixent within the next 14 days.
• Do notshake the pre-filled pen at any time.
• Do notheat the pre-filled pen.
• Do notfreeze the pre-filled pen.
• Do notexpose 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 container* (see Step D)

• Items not included in the packaging

A2. Check the label

• Confirm that you have the correct medication 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 medication

Look at the medication through the window of the pre-filled pen.

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

Note: You may see an air bubble, but this is normal.

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

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

A5. Wait 30 minutes

Place the pre-filled pen on a flat surface and let it warm up to room temperature (less than 25 °C) for at least 30 minutes.

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

Do notexpose the pre-filled pen to direct sunlight.

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

• Choose the injection site

B1. The recommended injection sites are:

• Thigh.
• Stomachavoiding the area around your navel.
• Upper arm.If a caregiver is giving you your dose, they can also use the outer aspect of the upper arm.

Choose a different injection site for each Dupixent injection.

Do notinject through clothing.

Do notinject into sensitive, damaged, or scarred skin.

B2. Wash your hands

B3. Prepare the injection site

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

Do nottouch the injection site or blow on it before the injection.

• Administer the injection

C1. Remove the yellow cap

Pull the yellow cap straight off.

Do nottwist the yellow cap.

Do notremove the yellow cap until you are ready to inject.

Do notpress or touch the orange needle cover with your fingers. The needle is inside.

Do notput the yellow cap back on the pre-filled pen after it has been removed.

C2. Pinch the skin and place

• Pinch the skin before and during the injection.
• Pinching is not necessary for adults and children over 12 years of age.
• When placing the orange needle cover on your skin, hold the pre-filled pen so that you can see the window.
• Place the orange needle cover on your skin at an angle of approximately 90 degrees.

Do notpress or touch the orange needle cover with your fingers. The needle is inside.

C3. Press down

Press the pre-filled pen firmly against your skin until the orange needle cover is no longer visible and hold it in place.

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

The injection may take up to 15 seconds.

Pinching is not necessary for adults and children over 12 years of age.

C4. Hold firmly

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

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

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

Do notadminister a second dose without talking to your healthcare professional.

Pinching is not necessary for adults and children over 12 years of age.

C5. Remove

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

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

Do notrub the skin after the injection.

• Dispose

• Throw away the pre-filled pens (with the needle inside) and the yellow caps in a sharps container immediately after use.

Do notthrow away the pre-filled pens (with the needle inside) and the yellow caps in the trash.

Do notput the yellow cap back on.