in , ,

Dupixent EMA Approval for Asthma and Atopic Dermatitis

Dupixent EMA Approval

Dupixent (Dupilumab) is a subcutaneous injection that blocks inflammation by inhibiting two key signaling pathways, IL-4 and IL-13.

Because the drug showed significant improvement in relieving symptoms of patients with moderate to severe asthma and eczema, it was approved by the EMA (European Medicines Agency) on 27th September 2017 initially for asthma.

Later, over the years, it was approved for atopic dermatitis and other inflammatory conditions mentioned below.

Dupixent EMA Approved Indications:

Dupixent has been approved by the EMA for the following indications in individuals 12 years of age or older [Ref]:

  • Severe asthma
  • Moderate to severe eczema (atopic dermatitis)
  • Severe chronic rhinosinusitis with nasal polyposis who have failed to respond to corticosteroids and surgery.
  • Moderate to severe prurigo nodularis
  • Eosinophilic esophagitis

For the treatment of atopic dermatitis, both the FDA and the EMA have reduced the age limit to 6 years.

You may also like to read:

Dupixent Dose and Formulations:

Dupixent is available in two formulations:

  • A prefilled pen, and
  • A prefilled Syringe

Both formulations contain 2 ml of the drug equivalent to a total dose of 300 mg (150 mg/ml).

Dupixent Dose in Atopic Dermatitis:

Condition/ ageWeightInitial DoseMaintenance Dose
Atopic Dermatitis in 6 – 11 years15 – 59 kg300 mg on Day 1,

300 mg on Day 15

300 mg every 4 weeks (starting 4 weeks after the 2nd dose)
60 kg or more600 mg (2×300 mg)300 mg every 14 days
Atopic Dermatitis in 12 years of age or more< 60 kg400 mg (2x 200 mg)200 mg every 14 days
> 60 kg600 mg (2×300 mg)300 mg every 14 days

Dupixent Dose in Asthma:

Condition/ ageWeightInitial and Maintenance Dose
Asthma in 6 – 11 years15 – 30 kg100 mg every 14 days, or

300 mg every 4 weeks

30 – 60 kg200 mg every 14 days, or

300 mg every 4 weeks

60 kg or more200 mg (2×300 mg) every 14 days

Dupixent Dose in adults and adolescents who are 12 years of age or older:

Asthma in 12 years of age or more
  • Severe asthma who are on oral corticosteroids, or
  • Who have co-morbid atopic dermatitis, or
  • Adults with comorbid chronic rhinosinusitis with nasal polyposis
600 mg (2x 300 mg)300 mg every 14 days
For all patients with asthma other than those mentioned above400 mg (2×200 mg)200 mg every 14 days

Dipixent Dose in CRSwNP (chronic rhinosinusitis with nasal polyposis):

  • 300 mg subcutaneous followed by repeat dosing every 14 days.

Dupixent Dose in Eosinophilic Esophagitis:

  • 300 mg every 14 days.

Dupixent Dose in Prurigo Nodularis:

  • 600 mg (2 injections of 300 mg) subcutaneously followed by 300 mg every other week.

If a dose is missed …

In case a patient misses his/her dose, the dose should be administered within 7 days of the recommended scheduled dose.

However, if more than 7 days have passed, a new dosing schedule should be followed starting from the day the new dose is administered and then every 14 or 28 days (depending on the recommendations) from the last dose.

How to administer Dupixent Injection via the Syringe (or Pen)?

Here are the steps that the person injecting it should follow:

  • Wash your hands with soap and water before administering the Dupixent injection
  • Remove the Dupixent prefilled syringe or pen from the refrigerator and allow it to reach room temperature for about 30-45 minutes.
  • Choose a clean, dry injection site on your abdomen, thigh, or upper arm.
  • Clean the injection site with an alcohol swab and allow it to dry.
  • Remove the needle cap from the prefilled syringe and hold the syringe with one hand, like a pencil.
  • Pinch the cleaned skin at the injection site with your other hand to create a small fold.
  • Insert the needle into the fold of the skin at a 45- to 90-degree angle, depending on the thickness of the skin and the length of the needle.
  • Slowly depress the plunger to inject the medication. You may feel a slight sting or burn during the injection.
  • Once the injection is complete, withdraw the needle from the skin and release the pinch on the skin.
  • Dispose of the used prefilled syringe and needle in a puncture-resistant container, as directed by your healthcare provider.

Dupixent Pen Vs Dupixent Syringe:


Dupixent Pen

Dupixent Syringe

Device DesignDisposable, pre-filled auto-injectorPre-filled glass syringe
Needle SizeFixed 27-gauge, ½ inch needleRequires a separate needle, size selected by a healthcare provider
Injection SiteUsually on the thighAbdomen, thigh, or upper arm
PreparationNo reconstitution or mixing requiredMedication requires preparation and withdrawal from the vial
AdministrationAutomatic injection via push-buttonManual injection by a healthcare provider or patient
Waste DisposalDispose of the entire device in a containerDispose of the syringe and needle in the container

Dupixent Side effects:

Here are some of the important side effects of Dupixent (Dupilumab):


Side Effect

SkinInjection site reactions, such as redness, swelling, itching, or pain
Eczema, worsening of existing eczema or new onset eczema-like rash
Skin infections
Dry skin
Alopecia (hair loss)
RespiratoryNasopharyngitis (inflammation of the nose and throat)
Upper respiratory tract infections
GastrointestinalGastroenteritis (inflammation of the stomach and intestines)
MusculoskeletalBack pain
Arthralgia (joint pain)
Myalgia (muscle pain)

Final words:

Dupixent (dupilumab) is a monoclonal antibody used to treat several inflammatory conditions, including moderate-to-severe atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

The European Medicines Agency (EMA) approved Dupixent for use in the European Union in 2017.

The drug works by blocking the action of interleukin-4 and interleukin-13, two proteins that play a role in the body’s immune response.

Clinical studies have shown that Dupixent can improve symptoms and reduce the need for other medications in patients with these conditions.

The drug is administered via subcutaneous injection and can be self-administered or given by a healthcare professional.

As with all medications, Dupixent may cause side effects, and patients should be monitored closely while receiving treatment.

Dupixent EMA Prescribing information is similar to the FDA prescribing information. Dupixent dose, side effects, and method of administration are summarized in table formats.

You may also like to read:

What do you think?

Written by Dr. Ahmed

I am Dr. Ahmed (MBBS; FCPS Medicine), an Internist and a practicing physician. I am in the medical field for over fifteen years working in one of the busiest hospitals and writing medical posts for over 5 years.

I love my family, my profession, my blog, nature, hiking, and simple life. Read more about me, my family, and my qualifications

Here is a link to My Facebook Page. You can also contact me by email at or at My Twitter Account
You can also contact me via WhatsApp 🙏

Coronary Artery Disease and diabetes type 2

Coronary Artery Disease and Diabetes Type 2

Imjudo (Tremelimumab) uses dose moa brands side effects

Imjudo (Tremelimumab) for HCC: FDA Prescribing Information