DUPIXENT does not have a boxed warning. In the DUPIXENT pivotal clinical trials, the most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis were injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile of DUPIXENT in pediatric patients 6 months to 17 years of age through Week 16 was similar to the safety profile from studies in adults with atopic dermatitis. The 52-week safety profile of DUPIXENT + TCS in adults was generally consistent with the Week 16 adult safety profile. In an open-label extension study (AD-1434), the safety profile of DUPIXENT ± TCS in pediatric patients observed through Week 52 was consistent with that seen in adults with atopic dermatitis. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in patients 6 months to 5 years of age. These cases did not lead to study drug discontinuation.1
Note: Select Important Safety Information: Warnings and Precautions–Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.1
Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.