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.
2. Castro M, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. NEJM 2018;378:2486–96.
3. Rabe KF, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. NEJM 2018;378:2475–85.
4. Wenzel S, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet 2016;388:31–44.


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MAT-CA-2300228
Last updated: 06/2023


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