Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - dupixent

Document Subject

Generated Narrative: MedicinalProductDefinition mpc73c6f869bb1947667a63b227920af77

identifier: http://ema.europa.eu/identifier/EU/1/17/1229/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Dupixent 300 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c73c6f869bb1947667a63b227920af77

identifier: http://ema.europa.eu/identifier/EU/1/17/1229/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - dupixent

Attesters

What is in this leaflet

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

What Dupixent is Dupixent contains the active substance dupilumab.

Dupilumab is a monoclonal antibody (a type of specialised protein) that blocks the action of proteins called interleukins (IL)-4 and IL-13. Both play a major role in causing the signs and symptoms of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis (PN) and eosinophilic esophagitis (EoE).

What Dupixent is used for Dupixent is used to treat adults and adolescents 12 years and older with 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 may be used with eczema medicines that you apply to the skin or it may be used on its own.

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

Dupixent is also used with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled with their current CRSwNP medicines. Dupixent can also reduce the need for surgery and the need for systemic corticosteroid use.

Dupixent is also used to treat adults with moderate-to-severe prurigo nodularis (PN), also known as chronic nodular prurigo (CNPG). Dupixent may be used with PN medicines that you apply to the skin or it may be used on its own.

Dupixent is also used to treat adults and adolescents 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE).

How Dupixent works Using Dupixent for atopic dermatitis (atopic eczema) can improve the condition of your skin and reduce itching. Dupixent has also been shown to improve symptoms of pain, anxiety, and depression associated with atopic dermatitis. In addition, Dupixent helps improve your sleep disturbance and overall quality of life.

Dupixent helps prevent severe asthma attacks (exacerbations) and can improve your breathing. 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.

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 you are not sure, ask your doctor, pharmacist or nurse for advice before using Dupixent.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Dupixent:

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

Every time you get a new pack of Dupixent, it is important that you note down the date and the batch number (which is on the packaging after Lot ) and keep this information in a safe place.

Allergic reactions

• Rarely, Dupixent can cause serious side effects, including allergic (hypersensitivity) reactions and anaphylactic reaction and angioedema. These reactions can occur from minutes until seven days after Dupixent administration. You must look out for signs of these conditions (i.e. breathing problems, swelling of the face, lips, mouth, throat or tongue, fainting, dizziness, feeling lightheaded (low blood pressure), fever, general ill feeling, swollen lymph nodes, hives, itching, joint pain, skin rash) while you are taking Dupixent. Such signs are listed under Serious side effects in section 4. * Stop using Dupixent and tell your doctor or get medical help immediately if you notice any signs of an allergic reaction.

Eosinophilic conditions

• Rarely patients taking an asthma medicine may develop inflammation of blood vessels or lungs due to an increase of certain white blood cells (eosinophilia).
• It is not known whether this is caused by Dupixent. This usually, but not always, happens in people who also take a steroid medicine which is being stopped or for which the dose is being lowered.
• Tell your doctor immediately if you develop a combination of symptoms such as a flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash.

Parasitic (intestinal parasites) infection

• Dupixent may weaken your resistance to infections caused by parasites. If you already have a parasitic infection it should be treated before you start treatment with Dupixent.
• Check with your doctor if you have diarrhoea, gas, upset stomach, greasy stools, and dehydration which could be a sign of a parasitic infection.
• If you live in a region where these infections are common or if you are travelling to such a region check with your doctor.

Asthma If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your doctor. Talk to your doctor before you stop Dupixent or if your asthma remains uncontrolled or worsens during treatment with this medicine.

Eye problems Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision.

Children and adolescents

• The safety and benefits of Dupixent are not yet known in children with atopic dermatitis below the age of 6 months.
• The safety and benefits of Dupixent are not yet known in children with asthma below the age of 6 years.
• The safety and benefits of Dupixent are not yet known in children with CRSwNP below the age of 18 years.
• The safety and benefits of Dupixent are not known in children with PN below the age of 18 years.
• The safety and benefits of Dupixent are not yet known in children with EoE below the age of years.

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 recently had or are due to have a vaccination.

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

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

Pregnancy and breast-feeding

• If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. The effects of this medicine in pregnant women are not known; therefore, it is preferable to avoid the use of Dupixent in pregnancy unless your doctor advises to use it.
• If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you will breast-feed or use Dupixent. You should not do both.

Driving and using machines
Dupixent is unlikely to influence your ability to drive and use machines.

Dupixent contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 300 mg dose, that is to say essentially sodium-free .

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much Dupixent you will receive Your doctor will decide which dose of Dupixent is right for you.

Recommended dose in adults with atopic dermatitis For patients with atopic dermatitis, the recommended dose of Dupixent is:

• An initial dose of 600 mg (two 300 mg injections)
• Followed by 300 mg given every other week by subcutaneous injection.

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:

Body weight of patient Initial dose Subsequent doses (every other week) less than 60 kg 400 mg (two 200 mg injections) 200 mg 60 kg or more 600 mg (two 300 mg injections) 300 mg

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:

Body weight of patient Initial dose Subsequent doses

15 kg to less than 60 kg 300 mg (one 300 mg injection) on Day 1, followed by 300 mg on Day 300 mg every 4 weeks*, starting 4 weeks after Day 15 dose 60 kg or more 600 mg (two 300 mg injections) 300 mg every other week

• The dose may be increased to 200 mg every other week based on 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:

Body Weight of Patient Initial Dose Subsequent Doses 5 kg to less than 15 kg 200 mg (one 200 mg injection) 200 mg every 4 weeks 15 kg to less than 30 kg 300 mg (one 300 mg injection) 300 mg every 4 weeks

Recommended dose in adult and adolescent patients with asthma (12 years of age and older) For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid severe 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 given every other week administered as subcutaneous injection.

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

• An initial dose of 400 mg (two 200 mg injections)
• Followed by 200 mg given every other week administered as subcutaneous injection.

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

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

200 mg every other week or 300 mg every 4 weeks 60 kg or more 200 mg every other week

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

Recommended dose in adults with chronic rhinosinusitis with nasal polyposis (CRSwNP) In CRSwNP, the recommended first dose of Dupixent is 300 mg followed by 300 mg given 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 300 mg injections)
• Followed by 300 mg given every other week by subcutaneous injection.

Recommended dose in adult and adolescent patients (12 years of age and older) with eosinophilic esophagitis (EoE) In EoE, the recommended dose of Dupixent is 300 mg given every week by subcutaneous injection (for patients with body weight of 40 kg or more).

Injecting Dupixent Dupixent is given 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 may also be given by a caregiver after proper training by a doctor or nurse.

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

Read carefully 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 the dose has been given too early, talk to your doctor, pharmacist or nurse.

If you forget to use Dupixent
If you have forgotten to inject a dose of Dupixent, talk to your doctor, pharmacist or nurse. In addition,

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

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

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

• give the Dupixent injection within 7 days from the missed dose, then continue with your original schedule.
• if the missed dose is not given within 7 days, wait until the next scheduled dose to give your Dupixent injection.

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

• give the Dupixent injection within 7 days from the missed dose, then continue with your original schedule.
• if the missed dose is not given within 7 days, start a new every 4 week dose schedule from the time you remember to take your Dupixent injection.

If you stop using Dupixent
Do not stop using Dupixent without speaking to your doctor first.

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

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

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

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

If you develop an allergic reaction, stop using Dupixent and talk to your doctor right away.

Other side effects

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

• injection site reactions (i.e. redness, swelling, itching, pain, bruising)
• eye redness and itching
• eye infection
• cold sores (on lips and skin)
• an increase in a certain kind of white blood cell (eosinophils)
• joint pain (arthralgia)

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

• swelling of the face, lips, mouth, throat or tongue (angioedema)
• eyelid itching, redness and swelling
• inflammation of the eye surface, sometimes with blurred vision (keratitis)
• facial rash or redness
• eye dryness

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

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

Additional side effects in children 6 to 11 years old with asthma Common: pinworms (enterobiasis)

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 refers to the last day of that month.

Store in a refrigerator (2 C to 8 C). Do not freeze. Store in the original carton to protect from light. If necessary, the pre-filled syringe can be removed from the refrigerator and kept in the pack for up to days at room temperature up to 25 C, while protected from light. The date of removal from the refrigerator shall be recorded in the space provided on the outer carton. The pack must be discarded if left out of the refrigerator for more than 14 days or if the expiry date has passed.

Do not use this medicine if you notice that the medicine is cloudy, discoloured, or has particles in it. Do not throw away any medicines via wastewater or household waste. Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use. These measures will help protect the environment.

What Dupixent contains

• The active substance is dupilumab.
• Each pre-filled syringe contains 300 mg of dupilumab in 2 mL solution for injection (injection).
• The other ingredients are L-Arginine monohydrochloride, L-Histidine, L-Histidine monohydrochloride monohydrate, Polysorbate 80 (E 433), Sodium acetate trihydrate, Acetic acid glacial (E 260), Sucrose, Water for injections.

What Dupixent looks like and contents of the pack Dupixent is a clear to slightly opalescent, colourless to pale yellow solution supplied in a glass pre- filled syringe with or without needle shield.

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

Not all pack sizes may be marketed.

Marketing Authorisation 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 Br ningstrasse Industriepark Hoechst 65926 FRANKFURT AM MAIN GERMANY

Genzyme Ireland Limited IDA Industrial Park Old Kilmeaden Road Waterford Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Sanofi Belgium T l/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium
T l/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Magyarorsz g SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0Danmark Sanofi A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l. Tel: +39 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 Tel. aus dem Ausland: +49 69 305 70 Nederland Sanofi B.V. Tel: + 31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71
Sanofi-Aventis AEBE : +30 210 900 16 sterreich sanofi-aventis GmbH Tel: +43 1 80 185 0

Espa a sanofi-aventis, S.A.
Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 France Sanofi Winthrop IndustrieT l: 0 800 222 Appel depuis l tranger : +33 1 57 63 23 Portugal Sanofi - Produtos Farmac uticos, Lda Tel: +351 21 35 89 Hrvatska
Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovenija Swixx Biopharma d.o.o.
Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l. Tel: 800 536Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA
Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: