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

Indications and Dosing Guidelines for Dupixent (Dupilumab)

Dupixent (dupilumab) is FDA-approved for multiple conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease, with specific dosing regimens for each indication based on age and weight. 1

Approved Indications

1. Atopic Dermatitis

• Adults: Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week (Q2W) 1
• Pediatric patients 6 months to 5 years:
  • 5 to <15 kg: 200 mg every 4 weeks
  • 15 to <30 kg: 300 mg every 4 weeks 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 2 weeks
  • ≥60 kg: 600 mg loading dose, then 300 mg every 2 weeks 1

2. 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
  • ≥30 kg: 200 mg every 2 weeks 1

3. Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

• Adults and pediatric patients ≥12 years: 300 mg every 2 weeks 1
• Dupilumab has demonstrated significant efficacy in reducing nasal polyp burden, improving quality of life, and reducing symptoms in patients with inadequately controlled CRSwNP 2, 3

4. Eosinophilic Esophagitis

• Adults and pediatric patients ≥1 year weighing at least 15 kg:
  • 15 to <30 kg: 200 mg every 2 weeks
  • 30 to <40 kg: 300 mg every 2 weeks
  • ≥40 kg: 300 mg every week 1

5. Prurigo Nodularis

• Adults: Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every 2 weeks 1

6. Chronic Obstructive Pulmonary Disease

• Adults: 300 mg every 2 weeks 1

Administration Guidelines

General Administration

• Administer subcutaneously into the thigh, abdomen, or upper arm 1
• Rotate injection sites with each injection 1
• Do not inject into skin that is tender, damaged, bruised, or scarred 1
• For initial loading doses requiring multiple injections, administer each injection at different sites 1

Pre-filled Pen or Pre-filled Syringe Use

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

Preparation

• Remove from refrigerator and allow to reach room temperature (45 minutes for 300 mg/2 mL or 30 minutes for 200 mg/1.14 mL) without removing needle cap
• After removal from refrigerator, must be used within 14 days or discarded
• Inspect visually for particulate matter and discoloration prior to administration 1

Special Considerations

Vaccination

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

Concomitant Therapy

• For atopic dermatitis: Can be used with or without topical corticosteroids; topical calcineurin inhibitors may be used for problem areas only 1
• For CRSwNP: Should be continued with intranasal corticosteroids 2

Monitoring

• Monitor for eye symptoms, particularly in patients with atopic dermatitis, as dupilumab can cause conjunctivitis and keratitis 4, 2
• For patients with CRSwNP: Regular assessment using validated measures such as SNOT-22, VAS, and smell testing 2
• For patients with pre-existing eye disease starting dupilumab for atopic dermatitis: Consider ophthalmology referral 4

Missed Doses

• Weekly dosing: Administer as soon as possible and restart weekly schedule from that date
• Every 2 week dosing: Administer within 7 days of missed dose and resume original schedule; if >7 days, wait until next scheduled dose
• Every 4 week dosing: Same guidance as every 2 week dosing 1

Common Adverse Effects

• Injection site reactions
• Nasopharyngitis
• Headache
• Conjunctivitis (particularly in atopic dermatitis patients) 2, 5

Dupilumab has demonstrated significant efficacy across multiple inflammatory conditions by inhibiting IL-4 and IL-13 signaling pathways, which are key drivers of type 2 inflammation 2, 6.