Contraindications, Warnings, and Precautions
Dupilumab is contraindicated in patients with a history of hypersensitivity to the drug or the excipients used in preparation of the solution. Hypersensitivity reactions to dupilumab appear to be rare, with an incidence < 1% in clinical trials. Symptoms range from pruritus and rash to anaphylaxis or serum sickness. A serum sickness-like reaction has also been reported, associated with the development of high levels of antibodies to dupilumab.
Conjunctivitis has been reported in approximately 10% of patients in dupilumab clinical trials. In the cases reported to date, conjunctivitis has been treated successfully without the need to discontinue dupilumab. In the May 2019 issue of the Journal of the European Academy of Dermatology and Venereology, 46 members of the International Eczema Council published a consensus statement to call attention to this adverse effect and provide guidance on the identification and treatment of conjunctivitis in patients with atopic dermatitis with and without dupilumab. The authors recommend that patients and their families be asked about signs and symptoms of eye discomfort, itching, or changes in vision prior to starting dupilumab and at every subsequent encounter. Patients who develop conjunctivitis should be referred to an ophthalmologist, with dupilumab continued whenever possible.
When used for the treatment of asthma, dupilumab has been associated with the development of systemic eosinophilic granulomatosis with polyangitis. Patients and families should report any signs of a rash, pulmonary, or cardiac symptoms to their healthcare provider. While systemic or topical corticosteroids may often be successfully reduced or discontinued after treatment with dupilumab has been started, they should be tapered gradually.
Pediatr Pharm. 2019;25(6) © 2019 University of Virginia