The Food and Drug Administration (FDA) has expanded the approval of the Dupixent® (dupilumab) single-dose prefilled pen to include use in pediatric patients 2 years of age and older for approved indications. Previously, the prefilled pen was only indicated for use in patients 12 years of age and older.

Dupixent is available as 200mg/1.14mL and 300mg/2mL solutions in single-dose prefilled pens, featuring a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration. In children 2 years to less than 12 years of age, Dupixent should be given by a caregiver. 

Dupixent is indicated for the following:

  • Treatment of patients 6 months of age 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.
  • As add-on maintenance treatment of patients 6 years of age and older with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
  • As add-on maintenance treatment in patients 18 years of age and older with inadequately controlled chronic rhinosinusitis with nasal polyposis.
  • Treatment of patients 12 years of age and older, weighing at least 40kg, with eosinophilic esophagitis.
  • Treatment of patients 18 years of age and older with prurigo nodularis.

The product is also available as a single-dose prefilled syringe for adult and pediatric patients aged 6 months and older in the following strengths: 300mg/2mL, 200mg/1.14mL, and 100mg/0.67mL.

Reference

Dupixent®. Package insert. Tarrytown, NJ: Regeneron; 2022. Accessed November 1, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s046lbl.pdf