How do I start dupilumab (Dupixent) in a patient with an approved indication (moderate-to-severe atopic dermatitis, asthma, or chronic rhinosinusitis with nasal polyps), including necessary screening, baseline laboratory assessment, vaccination status, dosing regimen, subcutaneous injection technique, and monitoring?

Starting Dupilumab (Dupixent): A Practical Guide

Before initiating dupilumab, complete age-appropriate vaccinations, screen for pre-existing ocular disease, and begin prophylactic preservative-free ocular lubricants in patients with any history of eye disease or eyelid/facial eczema. 1

Pre-Treatment Screening and Risk Assessment

Vaccination Status

• Complete all age-appropriate vaccinations according to current immunization guidelines before starting dupilumab. 2

Ocular Disease Screening

• Screen all patients for current or pre-existing corneal or conjunctival eye disease before initiation. 1
• Patients with any history of dry eye disease (OR 6.3), atopic conjunctivitis, keratitis, prior eye disease (OR 2.97), prior ophthalmic medication use (OR 5.16), or eyelid/facial eczema require prophylactic preservative-free ocular lubricants started before the first dupilumab dose. 3, 1
• Delay dupilumab in patients with reversible acute eye conditions (e.g., infectious conjunctivitis) until complete resolution. 1
• Delay dupilumab in patients with history of corneal transplant until ophthalmology consultation is obtained. 1
• Refer patients with significant current or chronic corneal or conjunctival disease to ophthalmology before starting therapy. 1

Baseline Laboratory Assessment

• No specific baseline laboratory tests are mandated by FDA labeling, though clinical judgment should guide assessment based on the underlying condition. 2

Dosing Regimens by Indication

Atopic Dermatitis (Adults)

• Loading dose: 600 mg (two 300 mg injections) subcutaneously at different injection sites 2
• Maintenance: 300 mg every 2 weeks 2
• Can be used with or without topical corticosteroids; reserve topical calcineurin inhibitors for problem areas only (face, neck, intertriginous and genital areas). 2

Atopic Dermatitis (Pediatric 6-11 Years)

• 15 to <30 kg: Loading dose 600 mg (two 300 mg injections), then 300 mg every 4 weeks 2
• 30 to <60 kg: Loading dose 400 mg (two 200 mg injections), then 200 mg every 2 weeks 2
• ≥60 kg: Loading dose 600 mg (two 300 mg injections), then 300 mg every 2 weeks 2

Chronic Rhinosinusitis with Nasal Polyps (Adults and Pediatric ≥12 Years)

• No loading dose required 2
• Maintenance: 300 mg every 2 weeks 2, 3
• Concomitant intranasal corticosteroids are mandatory: mometasone furoate nasal spray 100 μg in each nostril twice daily. 3, 4

Asthma (Adults and Pediatric ≥12 Years)

• Standard dosing: Loading dose 400 mg (two 200 mg injections), then 200 mg every 2 weeks 2
• For oral corticosteroid-dependent asthma OR co-morbid moderate-to-severe atopic dermatitis OR co-morbid chronic rhinosinusitis with nasal polyps: Loading dose 600 mg (two 300 mg injections), then 300 mg every 2 weeks 2

Asthma (Pediatric 6-11 Years)

• 15 to <30 kg: 300 mg every 4 weeks (no loading dose) 2
• ≥30 kg: 200 mg every 2 weeks (no loading dose) 2
• For patients with co-morbid moderate-to-severe atopic dermatitis, follow the atopic dermatitis dosing regimen which includes a loading dose. 2

Subcutaneous Injection Technique

Administration Sites

• Inject into the thigh or abdomen (except 2 inches around the navel). 2
• The upper arm can be used if a caregiver administers the injection. 2
• Rotate injection sites with each dose. 1, 2
• Do NOT inject into skin that is tender, damaged, bruised, or scarred. 2

Device Selection and Supervision

• Pre-filled pen: for patients aged ≥2 years 2
• Pre-filled syringe: for patients aged ≥6 months 2
• Patients ≥12 years or caregivers may self-inject using either device. 2
• Pediatric patients 6 months to <12 years: administer by caregiver only. 2
• Pediatric patients 12 years and older: administer under adult supervision. 2

Loading Dose Administration

• For loading doses requiring two injections (e.g., 600 mg = two 300 mg injections), administer at different injection sites during the same session. 2

Patient Education and Monitoring

Ocular Symptom Surveillance

• Educate patients to immediately report any eye symptoms, as ocular complications occur in 10-42% of atopic dermatitis patients, typically within the first 4 months. 1
• Bilateral eye involvement is typical for dupilumab-related ocular issues; unilateral symptoms suggest another cause requiring standard ophthalmology pathways. 5

RAPID Criteria for Emergency Ophthalmology Referral (<24 Hours)

• Redness of the conjunctiva PLUS any of the following: 1, 5
• Acuity loss or worsening 1, 5
• Pain in the eye 1, 5
• Intolerance of light (photophobia) 1, 5
• Damaged cornea visible or opacity 1, 5

First-Line Treatment for Mild-to-Moderate Ocular Symptoms

• Preservative-free ocular lubricants 2-4 times daily 1, 5
• Topical antihistamine eyedrops for moderate symptoms 5
• Continue dupilumab in most cases; only 4.2% of patients discontinue due to ocular complications. 5

Urgent Ophthalmology Referral (Within 4 Weeks)

• Severe redness at onset 5
• Cases requiring tacrolimus treatment 5
• Children <7 years with any ocular symptoms 5

Expected Clinical Outcomes

Atopic Dermatitis

• Significant improvement in skin disease with excellent overall safety profile over 10+ years of follow-up data. 1

Chronic Rhinosinusitis with Nasal Polyps

• Significant reductions at 24 weeks: 3, 4
  • Nasal polyp score: mean difference -1.79 3
  • Lund-Mackay CT score: standardized mean difference -1.50 3
  • SNOT-22 quality of life: mean difference -19.61 3
  • Nasal congestion score: mean difference -0.86 3
  • Sense of smell (UPSIT): mean difference +10.83 3
• Improvements in lung function (FEV1 mean difference +0.21 L) and asthma control in patients with comorbid asthma, regardless of baseline eosinophil count. 3

Critical Clinical Pitfalls to Avoid

• Do not skip prophylactic ocular lubricants in high-risk patients (those with any history of eye disease, eyelid eczema, or facial eczema), as this significantly increases DROSD risk. 3, 1
• Do not delay emergency ophthalmology referral for RAPID criteria symptoms, as visual outcomes depend on prompt intervention. 1, 5
• Do not forget concomitant intranasal corticosteroids for chronic rhinosinusitis with nasal polyps patients, as all pivotal trials used this combination. 3, 4
• Conjunctivitis is more common in atopic dermatitis trials but not observed in asthma and chronic rhinosinusitis with nasal polyps trials. 3
• Most adverse events (nasopharyngitis, worsening nasal polyps, headache, epistaxis, injection-site erythema) were more frequent with placebo in chronic rhinosinusitis with nasal polyps trials. 3