Dupixent 200 mg solucion inyectable en jeringa precargada

Label: information for the user

Dupixent 200 mg injectable solution in pre-filled syringe

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 adverse 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 of atopic dermatitis and asthma..

What is it used for

Dupixent is used to treat adults and adolescents12 years old and abovewith moderate to severe atopic dermatitis, also known as atopic eczema. Dupixent is also used to treat children 6 months to 11 years old with severe atopic dermatitis. 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 old and abovewhose asthma is not controlled with their current medication (e.g. corticosteroids).

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

How Dupixent works

The use of Dupixent for atopic dermatitis (atopic eczema) may improve your skin condition and reduce itching. Dupixent has also shown improvement of 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 also may 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.

No use Dupixent

• if you are allergic to dupilumab or any of the other components of this medication (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 to use Dupixent:

Dupixentis not a rescue medicationand should not be used to treat a sudden asthma attack.

Each time you receive a new package of Dupixent, it is essential to note the name of the medication, the date of administration, and the batch number (found on the package after “Batch”) and store this information in a safe place.

Severe allergic reactions

• Very rarely, Dupixent may cause severe side effects, including allergic reactions (hypersensitivity), anaphylactic reaction, and angioedema. These reactions may occur from minutes after administration of Dupixent to seven days after the same. While using Dupixent, you must 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, general feeling of discomfort, lymph node inflammation, hives, itching, joint pain, skin rash). These signs are listed in “Severe side effects” in section 4.
• Stop using Dupixent and seek medical help immediately if you notice any signs of a severe allergic reaction.

Eosinophilic diseases

• Rarely, patients taking an asthma medication 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 corticosteroid medication that has been discontinued or is having its dose reduced.
• If you experience a combination of symptoms including a condition similar to the flu, tingling or numbness in the arms or legs, worsening of lung symptoms, and/or rash, report to your doctor immediately.

Parasitic infections (intestinal parasites)

• 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 interrupting Dupixent treatment or if your asthma is not controlled or worsens during treatment with this medication.

Eye problems

Consult your doctor if eye problems appear or worsen, including pain in the eyes 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>withkg

Other medications and Dupixent

Inform your doctor or pharmacist

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

Other asthma medications

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

• These medications (especially those called corticosteroids) should be discontinued 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 medication. The effects of this medication 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 plan to breastfeed, consult your doctor before using this medication. Your doctor and you should decide whether to breastfeed or use Dupixent. Do not do both at the same time.

Driving and operating machinery

Dupixent is unlikely to affect your ability to drive and operate machinery.

Dupixent contains sodium

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

Dupixent contains polysorbate

This medication 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 have or your child has any known allergies.

Follow exactly the administration instructions of this medication as indicated 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 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 old) with atopic dermatitis is based on body weight:

Recommended dose in children aged 6 to 11 years 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 aged 6 months to 5 years with atopic dermatitis

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

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

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

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

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

• Initial dose of 600 mg (two injections of 300 mg)
• Followed by 300 mg administered every two weeks via 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 aged 6 to 11 years with asthma and severe co-existing atopic dermatitis, your doctor will decide what dose of Dupixent is suitable for you.

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

Dupixent injection

Dupixent is administered via subcutaneous injection under the skin. You and your doctor or nurse should decide whether to 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 syringe contains a dose of Dupixent (200 mg). Do not shake the pre-filled syringe.

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)
• lightheadedness, dizziness, feeling of dizziness (low blood pressure)
• fever
• general feeling of discomfort
• inflammation of lymph nodes
• itching
• pruritus
• 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 pre-filled syringe 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 disposed of through 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.

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 areL-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

Dupixentis a transparent to slightly opalescent, colorless to pale yellow solution that is presented in a pre-filled syringe of glass with a needle guard.

Dupixent is available as pre-filled syringes of 200 mg in a package containing 1 or 2 pre-filled syringes or in a multiple package containing 6 (3 packages of 2) pre-filled syringes.

Only some package 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

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

Last review date of this leaflet:

Other sources of information

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

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Dupixent 200mg solution for injection in pre-filled syringe with needle guard

dupilumab

Instructions for use

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

Important information

This device is a single-use pre-filled syringe. It contains 200mg of Dupixent for subcutaneous injection.

Do not attempt to administer the injection yourself or to another person, unless you have received training from your healthcare professional. In adolescents aged 12 years and older, Dupixent should be administered 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.
• Consult 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 administer the injection.
• Do notuse the syringe if it has fallen onto a hard surface or if it has been damaged.
• Do notuse the syringe if the needle guard is missing or not properly attached.
• Do nottouch the plunger rod until you are ready to administer the injection.
• Do notinject through clothing.
• Do nottry to remove air bubbles from the syringe.
• To help prevent accidental needlestick injuries, each pre-filled syringe comes with a needle guard that automatically activates to cover the needle after the injection has been administered.
• Neverpull back on the plunger rod.
• Do notre-use the syringe.

Storage of Dupixent

• Keep the syringe out of the reach of children.
• Keep unused syringes in the original package and store them in the refrigerator at 2 °C to 8 °C.
• Do notstore Dupixent at room temperature for more than 14 days. If you need to remove the package from the refrigerator permanently, write the date on which you remove it in the space provided on the outer package, and use Dupixent within 14 days.
• 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 package by grasping the middle of the syringe body.

Do notremove the needle guard until you are ready to administer the injection.

Do notuse the syringe if it has fallen onto a hard surface or if it has been damaged.

Step 2: Prepare

Make sure you have the following:

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

*Items not included in the package

Check the label:

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

Do notuse the syringe if the expiration date has passed.

Do notstore 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 transparent and colorless to pale yellow.

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

Do notuse the syringe if the liquid is cloudy or discolored, or if it contains lumps or particles.

Step 4: Wait 30minutes

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

Do notheat the syringe in a microwave, hot water, or direct sunlight.

Do notexpose the syringe to direct sunlight.

Do notstore Dupixent at room temperature for more than 14 days.

Step 5: Choose

Choose the injection site.

• You can inject the medicine into your thigh or abdomen (stomach), avoiding the area about 5cm around your navel.
• If someone else is giving you the injection, you can also inject it into the upper arm.
• Change the injection site each time you administer the injection.

Do notinject into sensitive, damaged, or bruised skin.

Step 6: Clean

Wash your hands.

Disinfect the injection site with an alcohol wipe.

Let the skin dry before proceeding with the injection.

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

Step 7: Pull

Hold the syringe by the middle of the syringe body, pointing the needle away from you and remove the needle guard.

Do notput the needle guard back on the needle.

Do nottouch the needle.

Inject the medicine immediately after removing the needle guard.

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 skin fold at an angle of about 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 bit of resistance, which is normal.

Step 11: Release and Remove

Lift your finger to release the plunger rod until the needle is covered by the needle guard and then remove the syringe from the injection site.

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

Do notput the needle guard back on the needle.

Do notrub the skin after the injection.

Step 12: Dispose

Dispose of the syringe and needle guard in a sharps container.

Do notput the needle guard back on the needle.

Always keep the sharps container out of the reach of children.