Dupixent 300 Mg 2 Prefilled Pen 2 Ml ( Refrigerator)

What dupilumab is used for:

• Dupilumab is used to treat adults and adolescents 12 years and older with moderate-to-severe atopic
  dermatitis, also known as atopic eczema.


• Dupilumab is also used to treat children 6 to 11 years old with severe atopic dermatitis.


• Dupilumab 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 and adolescents (12 years of age and older) whose asthma is not controlled with their current asthma medicines.
• Dupixent is also used with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled with their current CRSwNP medicines. Dupixent can also reduce the need for surgery and the need for systemic corticosteroid use.
  

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 dupilumab:

• Dupilumab is given by injection under the skin (subcutaneous injection).


• Recommended dose in adolescents with atopic dermatitis


• The recommended dose of dupilumab for adolescents (12 to 17 years of age) with atopic dermatitis is based on
  body weight:

Body Weight of

Patient

Initial Dose

Subsequent Doses

(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

• Recommended dose in children with atopic dermatitis

• The recommended dose of dupilumab for children (6 to 11 years of age) with atopic dermatitis is based on
  body
  weight:

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Body Weight of

Patient

Initial Dose

Subsequent Doses

(every other week)

15 kg to

Less than 60 kg

300 mg (one 300 mg injection) on Day 1,

Followed by 300 mg on Day 15

300 mg every 4 weeks*,

Starting 4 weeks after Day 15 dose

60 kg or more

600 mg (two 300 mg injections)

300 mg every 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 Dupilumab 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 Dupilumab 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 in adults with chronic rhinosinusitis with nasal polyposis (CRSwNP)
  In CRSwNP, the recommended first dose of Dupixent is 300 mg followed by 300 mg given every two weeks by 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.