Dupixent

Sanofi Egypt gets approval for registering Dupixent for Dermatitis & Asthma

Sanofi Egypt gets approval for registering Dupixent for Dermatitis & Asthma

Dupixent

Sanofi Egypt is the first company in Africa to obtain approval from the Egyptian Drug Authority for registering as a treatment for atopic dermatitis and severe uncontrolled asthma.

The General Manager of Sanofi Egypt said “This approval represents a new hope for patients suffering atopic dermatitis and severe uncontrolled asthma , therapeutic uses, side effects, dose, and more from this article.

What is Dupixent?

  • solution for injection in a pre-filled syringe.
  • It treats moderate-to-severe eczema (atopic dermatitis) that cannot be controlled with topical medicines applied to the skin.
  • It treats eczema in adults and children at least 6 years old.
  • is also used together with other medications to treat moderate-to-severe asthma that is not controlled with other asthma medicines.
  • It is used for asthma in adults and children at least 12 years old.
  • It is used only in adults to treat a condition called chronic rhinosinusitis (long-term sinus inflammation) that is associated with nasal polyps.

 

Active Ingredient

Dupilumab

 

What is the Mechanism of Action of Dupixent?

A monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13 signaling by specifically binding to the IL-4R-alpha subunit shared by the IL-4 and IL-13 receptor complexes

Blocking the IL-4R-alpha subunit inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines, and IgE

 

Dupixent and Pregnancy, Breastfeeding

  • When used in women with poorly or moderately controlled asthma, evidence demonstrates there is an increased risk of preeclampsia in the mother and prematurity. Low birth weight, and small for gestational age in the neonate as well. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.
  • There are no data on the presence of dupilumab in human milk, and its effects on the breastfed infant. A decision must be made whether to discontinue breastfeeding or to discontinue dupilumab therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

 

 

dose

Asthma

The recommended dose for adults and adolescents (12 years of age and older) is:

  • an initial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week or
  • an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week
  • for patients with oral corticosteroids-dependent asthma, or with co-morbid moderate-to-severe atopic dermatitis for which is indicated, start with an initial dose of 600 mg followed by 300 mg given every other week

Atopic Dermatitis

The recommended dose for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W).

Dose for Subcutaneous Administration in Pediatric Patients (6 to 17 Years of Age)

Body Weight Initial Dose Subsequent Doses
15 to less than 30 kg 600 mg (two 300 mg injections) 300 mg every 4 weeks (Q4W)
30 to less than 60 kg 400 mg (two 200 mg injections) 200 mg every other week (Q2W)
60 kg or more 600 mg (two 300 mg injections) 300 mg every other week (Q2W)

 

Does it Cure eczema and dermatitis ?

dupilumab is not a cure for eczema; however, it does effectively reduce symptoms in the majority of people prescribed it, such as:

  • Itching
  • The appearance of the rash

 

Is  an immunosuppressant ?

No, (dupilumab) is not an immunosuppressant or a steroid. works by targeting a type of protein called interleukin, which is involved in inflammation. Dupixent calms an overreactive immune system but it does not suppress the immune system. This leads to fewer and less severe symptoms of chronic inflammatory conditions, such as atopic dermatitis or asthma.

 

How to use ?

You can inject the pre-filled syringe into your thigh or stomach, except for the 2 inches (5 cm) around your belly button. If a caregiver injects the dose, they can also use the outer area of the upper arm.

Choose a different site each time you inject Dupixent. Do not inject into skin that is tender, damaged, bruised, or scarred.

Lay the Syringe on a flat surface and let it naturally warm to room temperature for at least 30 minutes (for the 200 mg syringe) or 45 minutes (for the 300 mg syringe). Do not heat the syringe or place in direct sunlight.

  • Before injection, wash your hands well with soap and water. Pinch a fold of skin at the injection site (thigh or stomach, except 2 inches around your belly button, or outer area of the upper arm if injected by your caregiver). Insert the needle completely into the fold of the skin at about a 45° angle.
  • Relax the pinch. Push the plunger rod down slowly and steadily as far as it will go until the Dupixent Syringe is empty. Lift your thumb to release the plunger rod until the needle is covered by the needle shield and then remove the syringe from the injection site.
  • Dispose of the syringe as directed.

injection

 

side effects

• eye pain or discomfort

• vision changes

• watery eyes (your eyes may be more sensitive to light)

• pain, swelling, burning, or irritation where an injection was given.

• blood vessel inflammation

• eye redness or itching, puffy eyelids

• stomach pain, nausea, vomiting

• sore throat

• tooth pain

• sleep problems (insomnia).

• joint pain.

• cold sores or fever blisters on your lips or in your mouth.

 

What is the Price in Egypt?

It costs around 3354 US dollars. We are not sure of the price here in Egypt in Egyptian Pounds. But once we are sure we’ll update it here as soon as possible.

 

See Also

What is asthma and How to treat it ? 

COPD 

Patient Leaflet 

References

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