Product Description:

• 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 IL-4 and IL-13. Both play a major role in causing the signs and symptoms of 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.
• Dupixent may be used with eczema medicines that you apply to the skin or it may be used on its own.
• Dupixent is used with other asthma medicines for the maintenance treatment of severe asthma in adults and adolescents (12 years of age and older) whose asthma is not controlled with their current asthma medicines.

Do not use dupilumab:

• If you are allergic to dupilumab or any of the other ingredients of this medicine


• If you think you may be allergic, or you are not sure, ask your doctor, pharmacist or nurse for advice before using dupilumab

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before using in cases of:

• Allergic reactions


• Eosinophilic conditions


• Parasitic (intestinal parasites) infection


• Asthma


• Eye problems

Possible side effects:

• Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing.


• Stop using the product if you develop hives or itching of the face or body.

Other medicines and dupilumab:

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 dupilumab.

How to use:

• Your doctor will decide which dose of Dupixent is right for you.
• Recommendeddose 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

InitialDose

SubsequentDoses (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

• Recommendeddose 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:

Body Weight of Patient

InitialDose

SubsequentDoses

15 kg to

less than 60 kg

300 mg (one 300 mg injection) on Day 1, followed by 300 mg on Day 15

300 mgevery 4 weeks*,

starting 4 weeks after Day 15 dose

60 kg or more

600 mg (two 300 mg injections)

300 mgevery other week

* 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 400mg (two 200mg injections)
• · Followed by 200mg 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 600mg (two 300mg injections)
• · Followed by 300mg given every other week administered as subcutaneous injection.

How to store dupilumab:

• Store in a refrigerator (2°C to 8°C).


• If necessary, pre-filled syringes may be kept at room temperature up to 25°C for a maximum of 14 days.


• Do not store above 25°C.


• If you need to permanently remove the carton from the refrigerator, write down the date of removal in the space provided on the outer carton, and use dupilumab within 14 days.


• Store in the original carton to protect from light.

* Dosage form and route of administration of Dupilumab 200 mg solution for injection in pre-filled syringe & Dupilumab 300 mg solution for injection in pre-filled syringe should be prescribed according to therapeutic indication and disease severity of each individual patient.