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 and asthma.

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 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).

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 Dupixent pre-filled pen is not intended for use in children below 6 years of age.

·         The safety and benefits of Dupixent are not yet known in children with atopic dermatitis below the age of 6 years.

·         The safety and benefits of Dupixent are not yet known in children with asthma below the age of 6.

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 200 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 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 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 other week based on the doctor’s opinion.

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:

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.

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.

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.

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)

·    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

To report any side effect(s):

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.