Dupixent Dupilumab Injection

1. Indications and Usage
Moderate-to-Severe Atopic Dermatitis:
Indicated for the treatment of adults and pediatric patients (6 months of age and older) with moderate-to-severe atopic dermatitis whose disease is not well controlled with topical prescription therapies or when those therapies are not advisable.
Asthma:
Indicated as an add-on maintenance treatment for adults and pediatric patients (6 years of age and older) with moderate-to-severe asthma with an eosinophilic phenotype.
Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP):
Indicated for the treatment of adults with disease that is uncontrolled with intranasal corticosteroids.
Eosinophilic Esophagitis (EoE):
Indicated for the treatment of adults and pediatric patients (12 years of age and older) weighing at least 40 kg with eosinophilic esophagitis.
Prurigo Nodularis:
Indicated for the treatment of adults with prurigo nodularis.
2. Dosage and Administration
Recommended Dosage:
Atopic Dermatitis (Adults): Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week.
Asthma/CRSwNP (Adults): 300 mg every other week. No initial loading dose.
Pediatric Patients: Dosing varies by age and weight (e.g., 10 mg/kg for 6 months to <6 years).
Administration Instructions:
Administer as a subcutaneous injection.
Allow the prefilled syringe to reach room temperature for 45 minutes before injection.
Inject into the thigh, abdomen (at least 5 cm away from the navel), or back of the upper arm (if self-administered by a caregiver).
3. Mechanism of Action
IL-4Rα Antagonist:
Dupilumab is a human monoclonal antibody (IgG4) that binds specifically to the IL-4 receptor alpha (IL-4Rα) subunit.
Physiological Effect:
By blocking the IL-4Rα subunit, it inhibits the signaling of Interleukin-4 (IL-4) and Interleukin-13 (IL-13). These cytokines are key drivers of type 2 inflammation (involving mast cells, eosinophils, etc.) in conditions like atopic dermatitis and asthma.
4. Safety and Warnings
Hypersensitivity:
Serious hypersensitivity reactions (e.g., anaphylaxis, serum sickness) have been reported. Discontinue if severe reactions occur.
Ocular Events:
Conjunctivitis and keratitis are common adverse reactions. Patients should be monitored for new or worsening eye symptoms.
Vaccinations:
Patients should not receive live vaccines while on dupilumab.
5. Adverse Reactions
Most Common:
Injection site reactions (redness, swelling, pain), conjunctivitis, blepharitis, dry skin, oral herpes, hot spots, and pharyngitis.
6. Drug Interactions
Live Vaccines:
Avoid concurrent use with live vaccines.
Topical Therapies:
Dupilumab can be used with or without topical corticosteroids or calcineurin inhibitors.
7. Pharmaceutical Information
Storage:
Store in the original carton at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. If removed from the refrigerator, allow to warm to room temperature before use.