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

Indications and Dosing Guidelines for Dupixent (Dupilumab)

Dupixent (dupilumab) is FDA-approved for multiple inflammatory conditions with specific dosing regimens based on indication, age, and weight. 1

Approved Indications

Atopic Dermatitis (AD)

• 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 (Q4W)
  • 15 to <30 kg: 300 mg every 4 weeks (Q4W) 1
• Pediatric patients 6-17 years:
  • 15 to <30 kg: 600 mg loading dose, then 300 mg Q4W
  • 30 to <60 kg: 400 mg loading dose, then 200 mg Q2W
  • ≥60 kg: 600 mg loading dose, then 300 mg Q2W 1

Asthma

• Adults and pediatric patients ≥12 years:
  • Standard dosing: 400 mg loading dose, then 200 mg Q2W; OR 600 mg loading dose, then 300 mg Q2W
  • For oral corticosteroid-dependent asthma or comorbid moderate-to-severe AD or CRSwNP: 600 mg loading dose, then 300 mg Q2W 1
• Pediatric patients 6-11 years:
  • 15 to <30 kg: 300 mg Q4W
  • ≥30 kg: 200 mg Q2W 1

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

• Adults and pediatric patients ≥12 years: 300 mg Q2W 1
• Significantly improves nasal polyp score, nasal congestion, sense of smell, and sinus opacification 2, 3

Eosinophilic Esophagitis

• Adults and pediatric patients ≥1 year weighing at least 15 kg:
  • 15 to <30 kg: 200 mg Q2W
  • 30 to <40 kg: 300 mg Q2W
  • ≥40 kg: 300 mg weekly 1

Prurigo Nodularis

• Adults: Initial dose of 600 mg, followed by 300 mg Q2W 1

Chronic Obstructive Pulmonary Disease (COPD)

• Adults: 300 mg Q2W 1

Chronic Spontaneous Urticaria (CSU)

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

Administration Guidelines

• Administer subcutaneously into the thigh, abdomen, or upper arm 1
• Rotate injection sites with each injection 1
• For initial loading doses, administer each injection at different sites 1
• Pre-filled pen is for patients ≥2 years; pre-filled syringe for patients ≥6 months 1
• For pediatric patients 12-17 years: administer under adult supervision 1
• For pediatric patients 6 months to <12 years: must be administered by a caregiver 1

Pre-Treatment Considerations

• Consider completing all age-appropriate vaccinations before initiating treatment 1
• For patients with history of corneal transplant: delay dupilumab therapy until discussion with ophthalmology 2
• For patients with acute eye conditions (e.g., infectious conjunctivitis): delay until resolution 2
• For patients with significant current or chronic corneal/conjunctival disease: refer to ophthalmology before starting 2

Concomitant Therapy

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

Monitoring and Safety

• Monitor for ocular symptoms, particularly in patients with atopic dermatitis 2, 3
• Risk factors for dupilumab-related ocular surface disorders include:
  • History of atopic dermatitis
  • Previous ophthalmology attendance for ocular surface disorder
  • Higher baseline AD severity 2
• Common adverse effects include injection site reactions, nasopharyngitis, headache, and conjunctivitis 3

Missed Doses

• If a weekly dose is missed: administer as soon as possible and restart weekly schedule from that date
• If a Q2W dose is missed: administer within 7 days of missed dose and resume original schedule
• If a Q4W dose is missed: administer within 7 days of missed dose and resume original schedule 1

Dupilumab has demonstrated significant efficacy across multiple inflammatory conditions, with a favorable safety profile that makes it a valuable treatment option for patients with inadequate response to conventional therapies.