Appropriate Dupixent (Dupilumab) Dosing for Pediatric Patients
The appropriate Dupixent (dupilumab) dosage for pediatric patients is weight-based, with specific FDA-approved regimens for different age groups: for children 6 months to 5 years with atopic dermatitis, 200 mg every 4 weeks for those 5 to <15 kg and 300 mg every 4 weeks for those 15 to <30 kg; for children 6 years and older, 300 mg every 4 weeks for those 15 to <30 kg, 200 mg every 2 weeks for those 30 to <60 kg, and 300 mg every 2 weeks for those ≥60 kg. 1
Age-Specific Dosing Guidelines
Children 6 Months to 5 Years (Atopic Dermatitis)
- 5 to <15 kg: 200 mg every 4 weeks (Q4W)
- 15 to <30 kg: 300 mg every 4 weeks (Q4W)
- No initial loading dose is recommended for this age group 1
Children 6 Years and Older (Atopic Dermatitis)
- 15 to <30 kg: Initial loading dose of 600 mg (two 300 mg injections), followed by 300 mg every 4 weeks (Q4W)
- 30 to <60 kg: Initial loading dose of 400 mg (two 200 mg injections), followed by 200 mg every 2 weeks (Q2W)
- ≥60 kg: Initial loading dose of 600 mg (two 300 mg injections), followed by 300 mg every 2 weeks (Q2W) 1
Children 6 to 11 Years (Asthma)
- 15 to <30 kg: 300 mg every 4 weeks (Q4W)
- ≥30 kg: 200 mg every 2 weeks (Q2W)
- No initial loading dose is recommended for asthma in this age group 1
Children 12 Years and Older (Multiple Indications)
- For asthma: 200 mg every 2 weeks (Q2W) or 300 mg every 2 weeks (Q2W)
- For chronic spontaneous urticaria:
- 30 to <60 kg: Initial loading dose of 400 mg, followed by 200 mg every 2 weeks
- ≥60 kg: Initial loading dose of 600 mg, followed by 300 mg every 2 weeks 1
Administration Guidelines
Delivery Method
- Pre-filled pen can be used in patients aged 2 years and older
- Pre-filled syringe can be used in patients aged 6 months and older 1
Administration Supervision
- Patients 12 years and older: Administration under adult supervision
- Patients 6 months to <12 years: Administration by a caregiver 1
Injection Technique
- Administer subcutaneously into the thigh or abdomen (except within 2 inches of navel)
- Upper arm can be used if a caregiver administers the injection
- Rotate injection sites with each dose
- Do not inject into skin that is tender, damaged, bruised, or scarred 1
Clinical Evidence and Efficacy
Research has demonstrated the efficacy of these dosing regimens in pediatric populations. In a phase 3 trial of children 6-11 years with severe atopic dermatitis, both weight-based dosing every 2 weeks and 300 mg every 4 weeks with concomitant topical corticosteroids showed significant improvement in disease signs, symptoms, and quality of life compared to placebo 2.
For children 6 months to <6 years with moderate-to-severe atopic dermatitis, a randomized controlled trial showed that weight-based dosing (200 mg for 5 to <15 kg; 300 mg for 15 to <30 kg) every 4 weeks significantly improved disease measures compared to placebo, with 28% achieving clear or almost clear skin versus 4% with placebo 3.
Important Considerations
Vaccination Timing: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating Dupixent 1
Concomitant Therapy: Dupixent can be used with or without topical corticosteroids for atopic dermatitis 1
Safety Profile: The most common adverse events in pediatric patients include injection site reactions and conjunctivitis. In clinical trials, conjunctivitis was more frequent with dupilumab than placebo, but no serious adverse events led to treatment discontinuation 3
Monitoring: Regular monitoring for adverse events is essential, particularly for injection site reactions and conjunctivitis 2
By following these weight-based and age-specific dosing guidelines, healthcare providers can optimize the efficacy and safety of Dupixent therapy for pediatric patients with atopic dermatitis, asthma, and other approved indications.