IMPORTANT SAFETY INFORMATION

Indication and clinical use:

Atopic Dermatitis

DUPIXENT® (dupilumab injection) is indicated for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 

DUPIXENT® can be used with or without topical corticosteroids.

• No dose adjustment is recommended for elderly patients
• Efficacy and safety of DUPIXENT® in pediatric patients with atopic dermatitis below the age of 6 years have not been established

Asthma

DUPIXENT® (dupilumab injection) is indicated as an add-on maintenance treatment in patients aged 6 years and older with severe asthma with a type 2/eosinophilic phenotype or oral corticosteroid-dependent asthma.

DUPIXENT® is not indicated for relief of acute bronchospasm or status asthmaticus.

• Efficacy and safety in pediatric patients with asthma below the age of 6 years have not been established

Chronic Rhinosinusitis with Nasal Polyposis

DUPIXENT® (dupilumab injection) is indicated as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery

• No dose adjustment is recommended for elderly patients.
• Efficacy and safety of DUPIXENT® in pediatric patients with CRSwNP have not been established

Contraindications:

Hypersensitivity to DUPIXENT® or to any ingredient in the formulation or component of the container.

Warnings and precautions:

• Reduction of corticosteroid dosage
• Systemic hypersensitivity reactions
• Elevation of blood eosinophils
• Eosinophilic pneumonia
• Not studied with live vaccines
• Conjunctivitis and keratitis
• Patients with helminth infection
• Patients with concomitant atopic conditions
• Acute asthma symptoms or deteriorating disease
• Pregnant and nursing women

For more information:

Consult the Product Monograph at http://products.sanofi.ca/en/dupixent-en.pdf for important information relating to adverse drug reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-589-6215.

References:
1. DUPIXENT® Product Monograph, sanofi-aventis Canada Inc., March 25, 2022.
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