DUPIXENT
Generic Name/API: dupilumab
Manufacturer: Regeneron Pharmaceuticals
Dosage Forms & Strength & Pack Size:
Single-Dose Pre-Filled Syringe with Needle Shield (3):
• Injection: 300 mg/2 mL
• Injection: 200 mg/1.14 mL
Single-Dose Pre-Filled Pen (3):
• Injection: 300 mg/2 mL
• Injection: 200 mg/1.14 mL
Storage:
DUPIXENT is sterile and preservative-free. Discard any unused portion.
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
If necessary, DUPIXENT may be kept at room temperature up to 25°C (77°F) for a
maximum of 14 days. Do not store above 25°C (77°F). After removal from the refrigerator,
DUPIXENT must be used within 14 days or discarded.
Do not expose DUPIXENT to heat or direct sunlight.
Do NOT freeze. Do NOT shake.
DUPIXENT is an interleukin-4 receptor alpha antagonist indicated:
Atopic Dermatitis
for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. (1.1)
Asthma
as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. (1.2)
Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus.
(1.2)
Chronic Rhinosinusitis with Nasal Polyposis
as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). (1.3)
Eosinophilic Esophagitis
for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE). (1.4)
Prurigo Nodularis
for the treatment of adult patients with prurigo nodularis (PN). (1.5)
Warnings and precautions
• Hypersensitivity: Hypersensitivity reactions including anaphylaxis, serum sickness, angioedema, urticaria, rash, erythema nodosum, and erythema multiforme have occurred. Discontinue DUPIXENT in the event of a hypersensitivity reaction. (5.1)
• Conjunctivitis and Keratitis: Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination, as appropriate. (5.2)
• Eosinophilic Conditions: Be alert to vasculitic rash, worsening pulmonary symptoms, and/or neuropathy, especially upon reduction of oral corticosteroids.
(5.3)
• Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Decrease steroids
gradually, if appropriate. (5.5)
• Arthralgia: Advise patients to report new onset or worsening joint symptoms to their healthcare provider. If symptoms persist or worsen, consider rheumatological
evaluation and/or discontinuation of DUPIXENT. (5.7)
• Parasitic (Helminth) Infections: Treat pre-existing helminth infections before initiating DUPIXENT. If patients become infected while receiving DUPIXENT and do not respond to anti-helminth treatment, discontinue DUPIXENT until the infection resolves. (5.8)
• Vaccinations: Avoid use of live vaccines. (5.9)
*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.
