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.
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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).
|Condition/ age||Weight||Initial Dose||Maintenance Dose|
|Atopic Dermatitis in 6 – 11 years||15 – 59 kg||300 mg on Day 1,
300 mg on Day 15
|300 mg every 4 weeks (starting 4 weeks after the 2nd dose)|
|60 kg or more||600 mg (2×300 mg)||300 mg every 14 days|
|Atopic Dermatitis in 12 years of age or more||< 60 kg||400 mg (2x 200 mg)||200 mg every 14 days|
|> 60 kg||600 mg (2×300 mg)||300 mg every 14 days|
Dupixent Dose in Asthma:
|Condition/ age||Weight||Initial and Maintenance Dose|
|Asthma in 6 – 11 years||15 – 30 kg||100 mg every 14 days, or
300 mg every 4 weeks
|30 – 60 kg||200 mg every 14 days, or
300 mg every 4 weeks
|60 kg or more||200 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||
||600 mg (2x 300 mg)||300 mg every 14 days|
|For all patients with asthma other than those mentioned above||400 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.
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.
|Device Design||Disposable, pre-filled auto-injector||Pre-filled glass syringe|
|Needle Size||Fixed 27-gauge, ½ inch needle||Requires a separate needle, size selected by a healthcare provider|
|Injection Site||Usually on the thigh||Abdomen, thigh, or upper arm|
|Preparation||No reconstitution or mixing required||Medication requires preparation and withdrawal from the vial|
|Administration||Automatic injection via push-button||Manual injection by a healthcare provider or patient|
|Waste Disposal||Dispose of the entire device in a container||Dispose of the syringe and needle in the container|
Here are some of the important side effects of Dupixent (Dupilumab):
|Skin||Injection site reactions, such as redness, swelling, itching, or pain|
|Eczema, worsening of existing eczema or new onset eczema-like rash|
|Alopecia (hair loss)|
|Respiratory||Nasopharyngitis (inflammation of the nose and throat)|
|Upper respiratory tract infections|
|Gastrointestinal||Gastroenteritis (inflammation of the stomach and intestines)|
|Arthralgia (joint pain)|
|Myalgia (muscle pain)|
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.
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