Dupixent 200 mg

Package leaflet: Information for the user

Package leaflet: Information for the user

What is in this leaflet

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

1. What Dupixent is and what it is used for

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 and chronic spontaneous urtircaria (CSU). 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 (see section Children and adolescents). 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 to treat chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older. 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.

2. What you need to know before you use Dupixent

3. How to use Dupixent

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 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 less than 60 kg 60 kg or more Initial dose 400 mg (two 200 mg injections) 600 mg (two 300 mg injections) Subsequent doses (every other week) 200 mg 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 15 kg to less than 60 kg 60 kg or more Initial dose Subsequent doses 300 mg (one 300 mg 300 mg every injection) 4 weeks*, on Day 1, starting followed by 4 weeks after 300 mg on Day 15 dose Day 15 600 mg (two 300 mg 300 mg every other week injections) *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 200 mg every (one 200 mg 4 weeks injection) 15 kg to less than 30 kg 300 mg 300 mg every (one 300 mg 4 weeks injection) Recommended dose in adult and adolescent patients with asthma (12 years of age and older) 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 given every other week administered as subcutaneous injection. 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. 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 200 mg every other week 60 kg or more 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 spontaneous urticaria (CSU) The recommended dose of Dupixent for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week. Recommended dose in adolescents with chronic spontaneous urticaria (CSU) The recommended dose of Dupixent for adolescents (12 to 17 years of age) with chronic spontaneous urticaria is based on body weight: Body Weight Initial Dose 30 to less than 60 kg 400 mg 200 mg every (two 200 mg other week injections) (Q2W) 60 kg or more Subsequent Doses 600 mg (two 300 mg every 300 mg other week injections) (Q2W) 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 pen contains one dose of Dupixent (200 mg). Do not shake the pre-filled pen. Read carefully the “Instructions for Use” included at the end of the package leaflet before using Dupixent.

4. Possible side effects

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 sicknesslike 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 (e.g. localized 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* *These eye side effects were common (up to 1 in 10 people) in patients with atopic dermatitis Rare (may affect up to 1 in 1000 people): • serious allergic (hypersensitivity) reactions • ulcers on the outer clear layer of the eye, sometimes with blurred vision (ulcerative keratitis)* *The side effect of ulcerative keratitis was uncommon (up to 1 in 100 people) in patients with atopic dermatitis Additional side effects in children 6 to 11 years old with asthma Common: pinworms (enterobiasis)

5. How to store 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 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 pen can be removed from the refrigerator and kept in the pack for up to 14 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.

6. Contents of the pack and other information