What is the recommended dupilumab (Dupixent) dosing schedule for asthma in patients 12 years or older weighing ≥30 kg and in children 6–11 years weighing <30 kg?

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Dupilumab Dosing for Asthma

For patients 12 years or older weighing ≥30 kg with asthma, administer dupilumab 400 mg loading dose (two 200 mg injections) followed by 200 mg every 2 weeks, or alternatively 600 mg loading dose (two 300 mg injections) followed by 300 mg every 2 weeks; for children 6-11 years weighing <30 kg, give 300 mg every 4 weeks without a loading dose. 1

Dosing by Age and Weight

Adults and Adolescents (≥12 years)

Standard dosing regimen:

  • Loading dose: 400 mg (two 200 mg injections) subcutaneously
  • Maintenance: 200 mg every 2 weeks (Q2W)

Alternative regimen:

  • Loading dose: 600 mg (two 300 mg injections)
  • Maintenance: 300 mg every 2 weeks (Q2W)

Higher dose required for:

  • Oral corticosteroid-dependent asthma
  • Co-morbid moderate-to-severe atopic dermatitis
  • Adults with co-morbid chronic rhinosinusitis with nasal polyps
    • Use 600 mg loading dose followed by 300 mg Q2W 1

Children 6-11 Years

Weight-tiered dosing (no loading dose):

  • 15 to <30 kg: 300 mg every 4 weeks (Q4W)
  • ≥30 kg: 200 mg every 2 weeks (Q2W) 1

Important exception: For children 6-11 years with asthma AND co-morbid moderate-to-severe atopic dermatitis, use the atopic dermatitis dosing schedule which includes a loading dose 1

Administration Details

  • Route: Subcutaneous injection
  • Sites: Thigh, abdomen (except 2 inches around navel), or upper arm (if caregiver administers)
  • Rotate injection sites with each dose
  • For loading doses requiring two injections, use different injection sites 1

Preparation and Storage

  • Remove from refrigerator and allow to reach room temperature:
    • 45 minutes for 300 mg/2 mL formulation
    • 30 minutes for 200 mg/1.14 mL formulation
  • Once removed from refrigerator, must be used within 14 days or discarded
  • Do not use if liquid contains visible particles, is discolored, or cloudy 1

Missed Dose Management

For Q2W dosing:

  • If missed dose administered within 7 days: resume original schedule
  • If missed dose NOT administered within 7 days: wait until next scheduled dose 1

For Q4W dosing:

  • If missed dose administered within 7 days: resume original schedule
  • If missed dose NOT administered within 7 days: administer dose and start new schedule from that date 1

Clinical Context

The weight-tiered dosing in children 6-11 years achieves mean serum concentrations within the therapeutic range established in adults and adolescents (29-80 mg/L), with steady-state reached by week 12 2. In the VOYAGE trial, this dosing demonstrated 59.3% reduction in severe asthma exacerbations compared to placebo in children with type 2 inflammatory asthma 3. The efficacy was consistent across patients with different allergen sensitization patterns, though benefits were numerically greater in those with mono- or multi-allergen sensitization 4.

Common pitfall: Do not confuse asthma dosing with atopic dermatitis dosing in children 6-11 years—asthma dosing does NOT include a loading dose unless the child has co-morbid moderate-to-severe atopic dermatitis 1.

References

2
Research

Dupilumab pharmacokinetics and effect on type 2 biomarkers in children with moderate-to-severe asthma.

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2023

3
Research

Dupilumab in Children with Uncontrolled Moderate-to-Severe Asthma.

The New England journal of medicine, 2021

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