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 [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 recovered or were recovering during the treatment period [see Clinical Trials Experience under Adverse Reactions].
Keratitis was reported in <1% of the DUPIXENT group (1 per 100 subject-years) and in 0% of the placebo group (0 per 100 subject-years) in the 16-week atopic dermatitis monotherapy trials. In the 52-week DUPIXENT + topical corticosteroids (TCS) atopic dermatitis trial, keratitis was reported in 4% of the DUPIXENT + TCS group (12 per 100 subject-years) and in 0% of the placebo + TCS group (0 per 100 subject-years). Most subjects with keratitis recovered or were recovering during the treatment period [see Clinical Trials Experience under Adverse Reactions].
Advise patients to report new onset or worsening eye symptoms to their healthcare provider.
Reduction of Corticosteroid Dosage: Do not discontinue systemic or topical 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.
Atopic Dermatitis Patients with Comorbid Asthma: Advise patients with comorbid 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 12 years of age and older with moderate-to-severe atopic dermatitis. A total of 251 adolescents ages 12 to 17 years old with moderate-to-severe atopic dermatitis were enrolled in Trial 6. The safety and efficacy were generally consistent between adolescents and adults [see Clinical Trials Experience under Adverse Reactions and Pharmacology: Pharmacodynamics: Clinical Studies: Atopic Dermatitis under Actions]. Safety and efficacy in pediatric patients (<12 years of age) with atopic dermatitis have not been established.
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].