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Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum and serum sickness or serum sickness-like reactions, were reported in less than 1% of subjects who received DUPIXENT in clinical trials. Two subjects in the atopic dermatitis development program experienced serum sickness or serum sickness-like reactions that were associated with high titers of antibodies to dupilumab. One subject in the asthma development program experienced anaphylaxis [see Immunogenicity under Adverse Reactions]. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT [see Clinical Trials Experience and Immunogenicity under Adverse Reactions].
Conjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT. Conjunctivitis was the most frequently reported eye disorder. Most subjects with conjunctivitis or keratitis recovered or were recovering during the treatment period [see Clinical Trials Experience under Adverse Reactions].
Among asthma subjects, the frequencies of conjunctivitis and keratitis were similar between DUPIXENT and placebo [see Clinical Trials Experience under Adverse Reactions].
Advise patients to report new onset or worsening eye symptoms to their healthcare provider.
Eosinophilic Conditions: Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis, conditions which are often treated with systemic corticosteroid therapy. These events may be associated with the reduction of oral corticosteroid therapy. Physicians should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. Cases of eosinophilic pneumonia were reported in adult patients who participated in the asthma development program and cases of vasculitis consistent with eosinophilic granulomatosis with polyangiitis have been reported with DUPIXENT in adult subjects who participated in the asthma development program. A causal association between DUPIXENT and these conditions has not been established.
Acute Asthma Symptoms or Deteriorating Disease: DUPIXENT should not be used to treat acute asthma symptoms or acute exacerbations. Do not use DUPIXENT to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with DUPIXENT.
Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical or inhaled corticosteroids abruptly upon initiation of therapy with DUPIXENT. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Patients with Co-morbid Asthma: Advise patients with atopic dermatitis who have co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.
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.
Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. If patients become infected while receiving treatment with DUPIXENT and do not respond to antihelminth treatment, discontinue treatment with DUPIXENT until the infection resolves.
Use in Children: Atopic Dermatitis: The safety and efficacy of DUPIXENT have been established in pediatric patients 6 months of age and older with moderate-to-severe atopic dermatitis [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions]. Use of DUPIXENT in this age group is supported by data from the following clinical trials: AD-1526 which included 251 pediatric subjects 12 to 17 years old with moderate-to-severe atopic dermatitis treated with DUPIXENT; AD-1652 which included 367 pediatric subjects ages 6 to 11 years of age with severe atopic dermatitis treated with DUPIXENT + TCS; AD-1539 which included 161 pediatric subjects 6 months to 5 years of age with moderate-to-severe atopic dermatitis treated with DUPIXENT + TCS; AD-1434, an open-label extension study that enrolled 275 pediatric subjects 12 to 17 years of age treated with DUPIXENT, 368 pediatric subjects 6 to 11 years of age treated with DUPIXENT ± TCS, and 180 pediatric subjects 6 months to 5 years of age treated with DUPIXENT ± TCS.
The safety and efficacy were generally consistent between pediatric and adults [see Clinical Trials Experience under Adverse Reactions and Pharmacology: Pharmacodynamics: Clinical Studies: Asthma under Actions]. In addition, hand-foot-and-mouth disease was reported in 9 (5%) pediatric subjects and skin papilloma was reported in 4 (2%) pediatric subjects 6 months to 5 years of age treated with DUPIXENT ± TCS in AD-1434. These cases did not lead to study drug discontinuation [see Clinical Trials Experience under Adverse Reactions].
Safety and efficacy in pediatric patients <6 months of age with atopic dermatitis have not been established.
Asthma: A total of 107 pediatric subjects aged 12 to 17 years with moderate-to-severe asthma were enrolled in QUEST and received either 200 mg (N=21) or 300 mg (N=18) DUPIXENT (or matching placebo either 200 mg [N=34] or 300 mg [N=34]) Q2W. Asthma exacerbations and lung function were assessed in both pediatric subjects 12 to 17 years of age and adults. For both the 200 mg and 300 mg Q2W doses, improvements in FEV1 (LS mean change from baseline at Week 12) were observed (0.36 L and 0.27 L, respectively). For the 200 mg Q2W dose, subjects had a reduction in the rate of severe exacerbations that was consistent with adults. Safety and efficacy in pediatric patients (<12 years of age) with asthma have not been established. Dupilumab exposure was higher in pediatric subjects 12 to 17 years of age than in adults at the respective dose level which was mainly accounted for by difference in body weight [see Pharmacology: Pharmacokinetics under Actions].
The adverse event profile in pediatric subjects 12 to 17 years of age was generally similar to the adults [see Clinical Trials Experience under Adverse Reactions].
Use in Elderly: Of the 1472 subjects with atopic dermatitis exposed to DUPIXENT in a dose-ranging study and placebo-controlled trials, 67 subjects were 65 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects [see Pharmacology: Pharmacokinetics under Actions].
Of the 1977 subjects with asthma exposed to DUPIXENT, a total of 240 subjects were 65 years or older. Efficacy and safety in this age group was similar to the overall study population.
