The most common adverse reactions (incidence ≥1%) 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. 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

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Safety Profile