CONTRAINDICATION: DUPIXENT (dupilumab) is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.
Hypersensitivity: Hypersensitivity reactions, including generalized urticaria and serum sickness or serum sickness-like reactions, were reported in <1% of subjects who received DUPIXENT. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in subjects who received DUPIXENT. Conjunctivitis was the most frequently reported eye disorder. Advise patients to report new onset or worsening eye symptoms to their healthcare provider.
Comorbid Asthma: Safety and efficacy of DUPIXENT have not been established in the treatment of asthma. Advise patients with comorbid asthma not to adjust or stop their asthma treatments without consultation with their healthcare provider.
Parasitic (Helminth) Infections: Patients with known helminth infections were excluded from participation in clinical studies. It is unknown if DUPIXENT will influence the immune response against helminth infections.
ADVERSE REACTIONS: The most common adverse reactions (incidence ≥1%) are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye.
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DUPIXENT is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis 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.