Dupilumab｜Chronic Spontaneous Urticaria｜HongKong DengYue Medicine

Dupilumab Application Scope

• Atopic Dermatitis (AD): Treatment of moderate-to-severe AD in adults and pediatric patients aged 6 months and older whose disease is not adequately controlled with topical therapies or when those therapies are not advisable.

• Asthma: Add-on maintenance treatment for moderate-to-severe asthma in adults and pediatric patients aged 6 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

• Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP): Add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled CRSwNP.

• Eosinophilic Esophagitis (EoE): Treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with EoE.

• Prurigo Nodularis (PN): Treatment of adult patients with PN.

• Chronic Obstructive Pulmonary Disease (COPD): Add-on maintenance treatment of adult patients with inadequately controlled COPD and an eosinophilic phenotype.

• Chronic Spontaneous Urticaria (CSU): Treatment of adult and pediatric patients aged 12 years and older with CSU who remain symptomatic despite H1 antihistamine treatment.

Dupilumab Characteristics

Ingredients:

• Active Ingredient: Dupilumab (a human monoclonal antibody targeting interleukin-4 receptor alpha). ​

• Excipients: Arginine hydrochloride, histidine, polysorbate 80, sodium acetate, sucrose, water for injection, adjusted to pH 5.9 with acetic acid.

Properties:

• Dupilumab is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling, key drivers in type 2 inflammatory diseases. ​

Specification:

• 200 mg/1.14 mL and 300 mg/2 mL.​

Packaging Specification:

• Pack sizes of 1, 2, 3, or 6 pre-filled syringes or pens per carton.

Storage:

• Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

• If necessary, may be kept at room temperature up to 77°F (25°C) for a maximum of 14 days. Do not freeze or expose to heat.

Expiry Date:

• The expiry date is indicated on the packaging.

Executive Standard:

• Approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).​

Approval Number:

• FDA Biologics License Application (BLA) Number: 761055.

Date of Revision:

• The prescribing information was last updated in April 2025.​

Manufacturer:

• Regeneron Pharmaceuticals, Inc. and Sanofi.

Guidelines for the Use of Dupilumab

Dosage and Administration:

• Atopic Dermatitis (Adults): Initial dose of 600 mg (two 300 mg injections), followed by 300 mg every two weeks.

• Asthma (Adults): Initial dose of 400 mg or 600 mg, followed by 200 mg or 300 mg every two weeks, depending on body weight and disease severity. ​

• Administration: Subcutaneous injection; rotate injection sites and avoid injecting into tender, damaged, or scarred skin.

Adverse Reactions:

• Common: Injection site reactions, conjunctivitis, eosinophilia, and oral herpes.​

• Serious: Hypersensitivity reactions including anaphylaxis, serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme.

Contraindications:

• Known hypersensitivity to dupilumab or any of its excipients.

Precautions:

• Monitor for signs of hypersensitivity reactions.​

• Avoid use of live vaccines during treatment.

Dupilumab Interactions

Drug Interactions:

• No significant drug interactions have been identified.​

• Caution is advised when co-administering with live vaccines.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.