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Hypersensitivity: Hypersensitivity reactions, including generalized urticaria, rash, erythema nodosum, erythema multiforme, anaphylaxis, serum sickness or serum sickness-like reactions and angioedema, have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT [see Clinical Trials Experience, Immunogenicity and Post Marketing Experience under Adverse Reactions].
Conjunctivitis and Keratitis: Conjunctivitis and keratitis adverse reactions have been reported in clinical trials.
Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT compared to those who received placebo. 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].
In subjects with CRSwNP, the frequency of conjunctivitis was 2% in the DUPIXENT group compared to 1% in the placebo group in the 24-week safety pool; these subjects recovered. There were no cases of keratitis reported in the CRSwNP development program [see Clinical Trials Experience under Adverse Reactions].
Conjunctivitis and keratitis adverse events have also been reported with DUPIXENT in postmarketing settings, predominantly in atopic dermatitis patients. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis.
Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate [see Clinical Trials Experience under Adverse Reactions].
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. Healthcare providers 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 subjects 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 as well as in adult subjects with co-morbid asthma in the CRSwNP development program. A causal association between DUPIXENT and these conditions has not been established.
Acute Symptoms of Asthma or Chronic Obstructive Pulmonary Disease or Deteriorating Disease: DUPIXENT should not be used to treat acute symptoms or acute exacerbations of asthma or COPD. Do not use DUPIXENT to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma or COPD remains uncontrolled or worsens after initiation of treatment with DUPIXENT.
Risk Associated with Abrupt 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 healthcare provider. 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 co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.
Arthralgia: Arthralgia has been reported with the use of DUPIXENT with some patients reporting gait disturbances or decreased mobility associated with joint symptoms; some cases resulted in hospitalization [see Clinical Trials Experience under Adverse Reactions]. In postmarketing reports, onset of arthralgia was variable, ranging from days to months after the first dose of DUPIXENT. Some patients' symptoms resolved while continuing treatment with DUPIXENT and other patients recovered or were recovering following discontinuation of DUPIXENT.
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.
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 anti-helminth treatment, discontinue treatment with DUPIXENT until the infection resolves. Adverse reactions of helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old who participated in the pediatric asthma development program [see Clinical Trials Experience under Adverse Reactions].
Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with DUPIXENT. Avoid use of live vaccines during treatment with DUPIXENT. It is unknown if administration of live vaccines during DUPIXENT treatment will impact the safety or effectiveness of these vaccines. Limited data are available regarding coadministration of DUPIXENT with non-live vaccines [see Pharmacology: Pharmacodynamics under Actions].
Use in Children: Atopic Dermatitis: The safety and effectiveness of DUPIXENT have been established in pediatric patients 6 months of age and older with moderate-to-severe atopic dermatitis, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable [see Pharmacology: Pharmacodynamics: Clinical Studies: Atopic Dermatitis 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 of age with moderate-to-severe atopic dermatitis. Of the 251 subjects, 82 were treated with DUPIXENT 200 mg Q2W (<60 kg) or 300 mg Q2W (≥60 kg) and 85 were treated with matching placebo.
AD-1652 which included 367 pediatric subjects 6 to 11 years of age with severe atopic dermatitis. Of the 367 subjects, 120 were treated with DUPIXENT 300 mg Q4W + TCS (15 to <30 kg) or 200 mg Q2W + TCS (≥30 kg) and 123 were treated with matching placebo + TCS.
AD-1539 which included 162 pediatric subjects 6 months to 5 years of age with moderate-to-severe atopic dermatitis. Of the 162 subjects, 83 were treated with DUPIXENT 200 mg Q4W + TCS (5 to <15 kg) or 300 mg Q4W + TCS (15 to <30 kg) and 79 subjects were assigned to be treated with matching placebo + TCS.
AD-1434, an open-label extension study that enrolled 275 pediatric subjects 12 to 17 years of age treated with DUPIXENT ± TCS, 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.
Liberty-AD-HAFT which included 27 pediatric subjects 12 to 17 years of age with atopic dermatitis with moderate-to-severe hand and/or foot involvement treated with DUPIXENT (N=14) or matching placebo (N=13).
The safety and effectiveness were generally consistent between pediatric and adult patients [see Clinical Trials Experience under Adverse Reactions and Pharmacology: Pharmacodynamics: Clinical Studies: Atopic Dermatitis 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 effectiveness in pediatric patients <6 months of age with atopic dermatitis have not been established.
Asthma: Pediatric Subjects (12 to 17 years of age): A total of 107 pediatric subjects aged 12 to 17 years with 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. Dupilumab exposure was higher in pediatric subjects 12 to 17 years of age than that 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].
Pediatric Subjects 6 to 11 years of age: A total of 408 pediatric subjects aged 6 to 11 years with asthma was enrolled in the VOYAGE study, which evaluated doses of 100 mg Q2W and 200 mg Q2W. The efficacy of DUPIXENT 300 mg Q4W in pediatric subjects aged 6 to 11 years is extrapolated from the efficacy of 100 mg and 200 mg Q2W in VOYAGE and 200 mg and 300 mg Q2W in adults and pediatric subjects 12 to 17 years of age (QUEST). Patients who completed the treatment period of the VOYAGE study could participate in the open label extension study (EXCURSION). Fourteen patients (≥15 to <30 kg) out of 365 patients were exposed to 300 mg Q4W in this study, and the safety profile was similar to that seen in VOYAGE.
Safety, efficacy, and pharmacokinetics in pediatric patients <6 years of age with asthma have not been studied.
CRSwNP: CRSwNP does not normally occur in pediatric patients. Safety and effectiveness in pediatric patients younger than 18 years of age with CRSwNP have not been established.
Prurigo Nodularis: Prurigo Nodularis rarely occurs in children. Safety and efficacy in pediatric patients with PN younger than 18 years have not been established.
Chronic Obstructive Pulmonary Disease: COPD does not normally occur in children. Safety and efficacy in pediatric patients with COPD younger than 18 years have not been established.
Use in the Elderly: Of the 1539 subjects with atopic dermatitis exposed to DUPIXENT in a dose-ranging study and placebo-controlled trials, 70 subjects were 65 years or older. Clinical trials of DUPIXENT in atopic dermatitis did not include sufficient numbers of subjects aged 65 years and over 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.
Of the 440 subjects with CRSwNP exposed to DUPIXENT, a total of 79 subjects were 65 years or older. Efficacy and safety in this age group were similar to the overall study population.
Of the 152 patients with PN exposed to DUPIXENT, a total of 37 were 65 years of age or older. Efficacy and safety in this age group were similar to the overall study population. A total of 8 patients were 75 years of age or older.
Of the 938 patients with COPD exposed to DUPIXENT, a total of 435 were 65 years of age and older including 116 patients 75 years of age and older. Efficacy and safety in this age group were similar to the overall study population.
