Severe asthma with type 2 inflammation

Active Ingredient: Dupilumab

Indication for Dupilumab

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised FeNO, who are inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment.

For this indication, competent medicine agencies globally authorize below treatments:

200-600 mg once every 2 weeks

Route of admnistration

Subcutaneous

Defined daily dose

200 - 600 mg

Dosage regimen

From 200 To 600 mg once every 14 day(s)

Loading dose

600 mg

Maintenance dose

300 mg

Detailed description

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

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, an initial dose of 600 mg, followed by 300 mg every other week administered as subcutaneous injection.
For all other patients, an initial dose of 400 mg, followed by 200 mg every other week administered as subcutaneous injection.

Patients receiving concomitant oral corticosteroids may reduce their steroid dose once clinical improvement with dupilumab has occurred. Steroid reductions should be accomplished gradually.

Dupilumab is intended for long-term treatment. The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient’s level of asthma control.

Missed dose

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Dosage considerations

Dupilumab is administered by subcutaneous injection into the thigh or abdomen, except for the 5 cm around the navel.

Active ingredient

Dupilumab
Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling. Dupilumab inhibits IL-4 signaling via the Type I receptor (IL-4Rα/γc), and both IL-4 and IL-13 signaling through the Type II receptor (IL-4Rα/IL-13Rα). IL-4 and IL-13 are major drivers of human type 2 inflammatory disease, such as atopic dermatitis, asthma, and CRSwNP. Blocking the IL-4/IL-13 pathway with dupilumab in patients decreases many of the mediators of type 2 inflammation. Read more about Dupilumab

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Summary of Product Characteristics (SPC) 2023: DUPIXENT 300 mg Solution for injection

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