DUPIXENT 200 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Dupixent 200 mg solution for injection in pre-filled syringe

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. 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 medicines for asthma, 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).

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

How Dupixent works

Using Dupixent for atopic dermatitis (atopic eczema) may improve your skin condition 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 are allergic to dupilumab or any of the other ingredients 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

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 date of administration, 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 you are 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 have 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, tell 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.

• Talk to 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

Talk to your doctor if eye problems appear or worsen, including eye pain or changes in vision.

Children and adolescents

• 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 1 year of age, or with a body weight <15 kg with eoe, are not yet known.< li>

Other medicines and Dupixent

Tell your doctor or pharmacist

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

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 in 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

Dupixent is unlikely to affect your ability to drive or 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. Tell your doctor if you or your child have any known allergy.

3. How to use Dupixent

Follow the instructions for administration of this medicine exactly 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 adolescents with atopic dermatitis

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

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

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

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

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:

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 comorbid atopic dermatitis or adults with severe comorbid chronic rhinosinusitis with nasal polyposis, 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 (6 to 11 years of age) with asthma is based on body weight:

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

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

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 you inject Dupixent yourself, you must have been properly trained by your doctor or nurse. Your Dupixent injection can also be given by a caregiver after proper training by a doctor or nurse. Each pre-filled syringe contains one dose of Dupixent (200 mg). Do not shake the pre-filled syringe. 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 have been given 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 time 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 first talking to your doctor.

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 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 syringe in the original package to protect it from light.

If necessary, the pre-filled syringe 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 syringe 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 glass pre-filled syringe with a needle shield.

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

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 medicinal product 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 200mg solution for injection in pre-filled syringe with needle shield

dupilumab

Instructions for Use

This drawing shows the parts of the Dupixent pre-filled syringe with needle shield.

Important Information

This device is a single-use pre-filled syringe. 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.

• Read all the instructions carefully before using the syringe.
• Check with your healthcare professional how often the medicine should be injected.
• Ask your healthcare professional to show you how to use the syringe correctly before using it for the first time.
• Change the injection site each time you inject.
• Do notuse the syringe if it has been dropped onto a hard surface or if it has been damaged.
• Do notuse the syringe if the needle shield is missing or not properly attached.
• Do nottouch the plunger rod until you are ready for injection.
• Do notinject through clothing.
• Do notattempt to remove air bubbles from the syringe.
• To help prevent accidental needle injuries, each pre-filled syringe comes with a needle shield that automatically activates to cover the needle after injection.
• Neverpull back on the plunger rod.
• Do notreuse the syringe.

Storage of Dupixent

• Keep the syringe(s) out of the reach of children.
• Keep unused syringes in the original container and store them in the refrigerator between 2 °C and 8 °C.
• Do notstore Dupixent at room temperature (<25 °c) for more than 14 days. if you need to remove the package from refrigerator permanently, write date removed it on space provided outer package, and use dupixent within days.< li>
• Do notshake the syringe at any time.
• Do notheat the syringe.
• Do notfreeze the syringe.
• Do notexpose the syringe to direct sunlight.

Step 1: Remove

Remove the syringe from the container by holding it in the middle of the syringe body.

Do not remove the needle shield until you are ready for injection.

Do not use the syringe if it has been dropped onto a hard surface or if it has been damaged.

Step 2: Prepare

Make sure you have:

• the Dupixent pre-filled syringe
• 1 alcohol swab*
• 1 cotton ball or gauze*
• a sharps container* (see Step 12)

• Items not included in the container

Check the label:

• Check the expiration date.
• Check that you have the correct medicine and dose.

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

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

Step 3: Check

Look at the medicine through the viewing window of the syringe:

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

Note: you may see an air bubble, which is normal.

Do not use the syringe if the liquid is cloudy or discolored, or if it contains flakes or particles.

Step 4: Wait 30minutes

Place the syringe on a flat surface for at least 30 minutes and let it reach room temperature naturally.

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

Do not expose the syringe to direct sunlight.

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

Step 5: Choose

Select the injection site.

• You can inject the medicine into your thigh or stomach (abdomen), avoiding the area around your navel.
• If someone else is giving you the injection, it can also be given in the upper arm.
• Change the injection site each time you inject.

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

Step 6: Clean

Wash your hands.

Disinfect 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 injection.

Step 7: Pull

Hold the syringe by the middle of the syringe body, with the needle pointing away from you, and pull off the needle shield.

Do not put the needle shield back on the needle.

Do not touch the needle.

Inject the medicine immediately after removing the needle shield.

Step 8: Pinch

Pinch a fold of skin at the injection site, as shown in the drawing.

Step 9: Insert

Insert the needle completely into the fold of skin at an angle of approximately 45°.

Step 10: Push

Release the pinch.

Push the plunger rod down slowly and continuously until it stops and the syringe is empty.

Note: you will feel a little resistance, which is normal.

Step 11: Release and Remove

Lift your thumb to release the plunger rod until the needle is covered by the needle shield, then remove the syringe from the injection site.

If you see a little blood, press gently on the injection site with a cotton ball or gauze.

Do not put the needle shield back on the needle.

Do not rub the skin after injection.

Step 12: Dispose

Throw away the syringe and needle shield in a sharps container.

Do not put the needle shield back on the needle.

Always keep the container out of the reach of children.