Dupixent injection for treating moderate-to-severe atopic dermatitis and other inflammatory conditions

Dupixent (dupilumab) is a subcutaneous injection used to treat several chronic inflammatory diseases. It is approved for patients from infancy to adulthood with moderate-to-severe atopic dermatitis and several other conditions characterized by type 2 inflammation, such as asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and others. Dupixent works by blocking specific immune pathways involved in inflammation.

Dupixent is approved for use in the following conditions and patient groups:

• Atopic dermatitis: Treatment of moderate-to-severe atopic dermatitis in adults and children aged 6 months and older when topical prescription therapies are inadequate or not advisable. It can be used with or without topical corticosteroids.
• Asthma: Add-on maintenance treatment for moderate-to-severe asthma in patients aged 6 years and older with an eosinophilic phenotype or oral corticosteroid-dependent asthma. Not for acute bronchospasm or status asthmaticus.
• Chronic rhinosinusitis with nasal polyps (CRSwNP): Add-on maintenance treatment in patients aged 12 years and older with inadequately controlled disease.
• Eosinophilic esophagitis (EoE): Treatment in patients aged 1 year and older weighing at least 15 kg.
• Prurigo nodularis (PN): Treatment of adult patients.
• Chronic obstructive pulmonary disease (COPD): Add-on maintenance treatment of adult patients with inadequately controlled COPD and an eosinophilic phenotype. Not for acute bronchospasm.
• Chronic spontaneous urticaria (CSU): Treatment in patients aged 2 years and older remaining symptomatic despite H1 antihistamine treatment. Not for other urticaria forms.
• Bullous pemphigoid (BP): Treatment of adult patients.
• Allergic fungal rhinosinusitis (AFRS): Treatment in patients aged 6 years and older with a history of sino-nasal surgery.

dupilumab

Dupixent is a monoclonal antibody that targets the interleukin-4 receptor alpha subunit. By blocking this receptor, Dupixent inhibits signaling of interleukin-4 and interleukin-13, key drivers of type 2 inflammation. This action disrupts the inflammatory response involved in conditions like atopic dermatitis, asthma, and eosinophilic esophagitis, helping to reduce inflammation and symptom severity.

Administration

Dupixent is given by subcutaneous injection. The pre-filled syringe is for patients aged 6 months and older; the pre-filled pen is for patients 2 years and older. Patients or caregivers receive instruction on proper injection technique. Injections should be rotated between the thigh, abdomen (avoiding 2 inches around the navel), or upper arm if administered by a caregiver.

Atopic Dermatitis

• Adults: Initial dose of 600 mg (two 300 mg injections), then 300 mg every 2 weeks.
• Children 6 months to 5 years: No loading dose. For 5 to <15 kg, 200 mg every 4 weeks; for 15 to <30 kg, 300 mg every 4 weeks.
• Children 6 to 17 years: Loading and maintenance doses vary by weight:
  15 to <30 kg: 600 mg loading (two 300 mg injections), then 300 mg every 4 weeks;
  30 to <60 kg: 400 mg loading (two 200 mg injections), then 200 mg every 2 weeks;
  ≥60 kg: 600 mg loading, then 300 mg every 2 weeks.

Asthma

• Patients 12 years and older: Initial dose 400 mg (two 200 mg injections) then 200 mg every 2 weeks, or initial 600 mg (two 300 mg injections) then 300 mg every 2 weeks.
• Children 6 to 11 years: No loading dose.
  15 to <30 kg: 300 mg every 4 weeks;
  ≥30 kg: 200 mg every 2 weeks.

Other Conditions

• Chronic rhinosinusitis with nasal polyps (≥12 years): 300 mg every 2 weeks.
• Eosinophilic esophagitis (≥1 year, ≥15 kg): Weight-based dosing every 2 weeks or weekly.
  15 to <30 kg: 200 mg Q2W;
  30 to <40 kg: 300 mg Q2W;
  ≥40 kg: 300 mg weekly.
• Prurigo nodularis (adults): Initial 600 mg, then 300 mg every 2 weeks.
• Chronic obstructive pulmonary disease (adults): 300 mg every 2 weeks.
• Chronic spontaneous urticaria: Dosage varies by age and weight similar to atopic dermatitis, with loading doses for patients 6 years and older.
• Bullous pemphigoid (adults): Initial 600 mg, then 300 mg every 2 weeks, used with tapering oral corticosteroids.
• Allergic fungal rhinosinusitis: Adults 300 mg every 2 weeks; pediatric dosing weight-based.

Additional Notes

• Do not abruptly stop corticosteroids when starting Dupixent; taper gradually if appropriate.
• If a dose is missed, administer as soon as possible and resume the schedule accordingly, restarting timing from the new dose if late.
• Allow the injection to reach room temperature before administration and inspect for particulate matter or discoloration. Discard unused product as it contains no preservatives.

Dupixent is contraindicated in patients with known hypersensitivity to dupilumab or any excipients in the formulation.

• Hypersensitivity reactions: Severe allergic reactions including anaphylaxis, angioedema, serum sickness, rash, and others can occur. Discontinue treatment if these occur.
• Eye issues: Conjunctivitis, keratitis, and blepharitis have been reported, especially in atopic dermatitis patients. Patients should report new or worsening eye symptoms promptly. Consider ophthalmologic evaluation; discontinue if symptoms persist despite standard treatment.
• Eosinophilic conditions: Watch for vasculitis-related symptoms such as rash, worsening lung symptoms, or neuropathy, especially during corticosteroid taper.
• Corticosteroid dosage: Do not stop corticosteroids abruptly upon starting Dupixent; taper slowly.
• Psoriasis and joint symptoms: New-onset psoriasis and arthralgia including psoriatic arthritis have been reported; monitor and consider dermatologic or rheumatologic evaluation. Discontinue if symptoms worsen.
• Parasitic infections: Treat existing helminth infections before treatment. Discontinue Dupixent if infection does not respond to therapy.
• Vaccinations: Avoid live vaccines during treatment. Complete age-appropriate vaccinations before starting.
• Not for acute relief: Dupixent should not be used to treat acute asthma or COPD attacks.

Common adverse reactions vary by condition but include:

• Atopic dermatitis: Injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex infections, dry eye, eosinophilia.
• Asthma: Injection site reactions, oropharyngeal pain, eosinophilia.
• Chronic rhinosinusitis with nasal polyps: Injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, conjunctivitis.
• Eosinophilic esophagitis: Injection site reactions, upper respiratory infections, arthralgia, herpes viral infections.
• Prurigo nodularis: Nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, diarrhea.
• Chronic obstructive pulmonary disease: Viral infections, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infections, local reactions, rhinitis, eosinophilia, toothache, gastritis.
• Chronic spontaneous urticaria: Injection site reactions.
• Bullous pemphigoid: Arthralgia, conjunctivitis, blurred vision, herpes viral infections, keratitis.

Avoid live vaccines during treatment with Dupixent. Limited data exist on coadministration with non-live vaccines. Treat helminth infections before initiation; discontinue if infections fail to respond to treatment during Dupixent therapy.

Store Dupixent refrigerated. Before injection, allow to reach room temperature (45 minutes for 300 mg/2 mL pre-filled syringe or pen; 30 minutes for 200 mg/1.14 mL pre-filled syringe or pen) without removing needle cap. Use within 14 days after removal from refrigerator. Inspect for particulate matter and discoloration before use; discard if present. Do not freeze or shake.