What are the indications and dosing guidelines for Dupixent (dupilumab)?

Dupilumab (Dupixent): Indications and Dosing Guidelines

Dupilumab is FDA-approved for multiple inflammatory conditions with specific dosing regimens based on age, weight, and indication, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and eosinophilic COPD.

Approved Indications

Atopic Dermatitis

• Adults: Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week 1
• Pediatric patients 6-17 years:
  • 15 to <30 kg: 600 mg loading dose, then 300 mg every 4 weeks
  • 30 to <60 kg: 400 mg loading dose, then 200 mg every other week
  • ≥60 kg: 600 mg loading dose, then 300 mg every other week 1
• Pediatric patients 6 months to 5 years:
  • 5 to <15 kg: 200 mg every 4 weeks (no loading dose)
  • 15 to <30 kg: 300 mg every 4 weeks (no loading dose) 1

Asthma

• Adults and pediatric patients ≥12 years:
  • Standard dosing: 400 mg loading dose, then 200 mg every 2 weeks OR 600 mg loading dose, then 300 mg every 2 weeks
  • For oral corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis or CRSwNP: 600 mg loading dose, then 300 mg every 2 weeks 1
• Pediatric patients 6-11 years:
  • 15 to <30 kg: 300 mg every 4 weeks (no loading dose)
  • ≥30 kg: 200 mg every other week (no loading dose) 1

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

• Adults and pediatric patients ≥12 years: 300 mg every other week 1, 2

Eosinophilic Esophagitis

• Adults and pediatric patients ≥1 year (≥15 kg):
  • 15 to <30 kg: 200 mg every other week
  • 30 to <40 kg: 300 mg every other week
  • ≥40 kg: 300 mg every week 1

Prurigo Nodularis

• Adults: Initial dose of 600 mg, followed by 300 mg every other week 1

Chronic Obstructive Pulmonary Disease (COPD)

• Adults: 300 mg every other week 1

Chronic Spontaneous Urticaria

• Adults and pediatric patients ≥12 years who remain symptomatic despite H1 antihistamine treatment 3

Administration Guidelines

Preparation and Injection Technique

• Administer subcutaneously into the thigh, abdomen (except 2 inches around navel), or upper arm 1
• Rotate injection sites with each administration 1
• Allow pre-filled syringe/pen to reach room temperature before injection:
  • 45 minutes for 300 mg/2 mL
  • 30 minutes for 200 mg/1.14 mL 1
• After removal from refrigerator, must be used within 14 days 1

Age-Specific Administration

• Pre-filled pen: For patients ≥2 years
• Pre-filled syringe: For patients ≥6 months
• Patients 12-17 years: Administer under adult supervision
• Patients 6 months to <12 years: Must be administered by a caregiver 1

Vaccination Considerations

• Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment 1

Monitoring and Safety Considerations

Ocular Monitoring

• Refer patients with significant current or chronic corneal/conjunctival eye disease to ophthalmology before starting dupilumab 2
• Delay treatment in patients with history of corneal transplant until discussion with ophthalmology 2
• Monitor for dupilumab-related ocular surface disorders, especially in patients with atopic dermatitis 2, 3
• Risk factors for ocular complications include:
  • Pre-existing dry eye disease or keratitis
  • Higher baseline AD severity
  • Eyelid or facial eczema
  • Elevated eosinophil count or total IgE at baseline 2

Common Adverse Effects

• Injection site reactions
• Nasopharyngitis
• Headache
• Conjunctivitis and keratitis (particularly in atopic dermatitis patients) 3

Efficacy Outcomes

For CRSwNP

• Significantly improves:
  • Nasal polyp score
  • SNOT-22 quality of life scores
  • Rhinosinusitis disease severity
  • Nasal congestion/obstruction
  • Sense of smell
  • Sinus opacification on CT 2, 3

For Atopic Dermatitis

• Significantly improves signs and symptoms in patients with inadequate response to conventional topical treatments 2, 4
• Can be used with or without topical corticosteroids 1

For Asthma

• Reduces exacerbations and systemic corticosteroid use 3, 5
• Improves lung function regardless of baseline eosinophil count 6

Special Considerations

Missed Doses

• If weekly dose is missed: Administer as soon as possible and restart weekly schedule from that date
• If every other week dose is missed: Administer within 7 days, then resume original schedule
• If every 4 week dose is missed: Administer within 7 days, then resume original schedule 1

Concomitant Therapy

• Can be used with or without topical corticosteroids for atopic dermatitis
• Topical calcineurin inhibitors may be used for problem areas (face, neck, intertriginous and genital areas) 1

By following these specific dosing guidelines and monitoring recommendations, dupilumab can effectively treat multiple inflammatory conditions with an acceptable safety profile.