Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a healthcare provider. Risk Associated with Abrupt Reduction of Corticosteroid Dosage: Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon initiation of DUPIXENT. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of DUPIXENT. A causal association between DUPIXENT and these conditions has not been established.Īcute Asthma Symptoms or Deteriorating Disease: Do not use DUPIXENT to treat acute asthma symptoms, acute exacerbations, acute bronchospasm or status asthmaticus. Cases of eosinophilic pneumonia were reported in adult subjects who participated in the asthma development program and cases of vasculitis consistent with EGPA 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.
Healthcare providers should be alert to vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients with eosinophilia. These events may be associated with the reduction of oral corticosteroid therapy. Consider ophthalmological examination for patients who develop conjunctivitis that does not resolve following standard treatment or signs and symptoms suggestive of keratitis, as appropriate.Įosinophilic 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 (EGPA), conditions which are often treated with systemic corticosteroid therapy. Advise patients to report new onset or worsening eye symptoms to their healthcare provider. Some patients reported visual disturbances (e.g., blurred vision) associated with conjunctivitis or keratitis. Conjunctivitis and keratitis have been reported with DUPIXENT in postmarketing settings, predominantly in AD patients.
Conjunctivitis also occurred more frequently in chronic rhinosinusitis with nasal polyposis subjects and prurigo nodularis subjects who received DUPIXENT compared to those who received placebo. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT.Ĭonjunctivitis and Keratitis: Conjunctivitis and keratitis occurred more frequently in atopic dermatitis subjects who received DUPIXENT versus placebo, with conjunctivitis being the most frequently reported eye disorder. Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. CONTRAINDICATION: DUPIXENT is contraindicated in patients with known hypersensitivity to dupilumab or any of its excipients.
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