Dupilumab

Therapeutic indications

Dupilumab is indicated for:

Atopic dermatitis

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Adults and adolescents

Dupilumab is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Children 6 months to 11 years of age

Dupilumab is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Severe asthma with type 2 inflammation

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

Adults and adolescents

Dupilumab 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 fraction of exhaled nitric oxide (FeNO) who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

Children 6 to 11 years of age

Dupilumab is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO) who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Chronic rhinosinusitis with nasal polyposis (CRSwNP)

Population group: only adults (18 years old or older)

Dupilumab is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Moderate-to-severe prurigo nodularis (PN)

Population group: only adults (18 years old or older)

Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Eosinophilic esophagitis (EoE)

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

Dupilumab is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Chronic obstructive pulmonary disease (COPD)

Population group: only adults (18 years old or older)

Dupilumab is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

Contraindications

Dupilumab is contraindicated in the following cases:

Lactation

Lactation

Acute asthma exacerbations

at least one of
Acute severe exacerbation of asthma
Acute exacerbation of chronic obstructive airways disease

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