Vaccinations: Consider completing all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating DUPIXENT. Helminth infections (5 cases of enterobiasis and 1 case of ascariasis) were reported in pediatric patients 6 to 11 years old in the pediatric asthma development program. 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. Treat patients with pre-existing helminth infections before initiating therapy with DUPIXENT. Parasitic (Helminth) Infections: It is unknown if DUPIXENT will influence the immune response against helminth infections. If symptoms persist or worsen, consider rheumatological evaluation and/or discontinuation of DUPIXENT. Advise patients to report new onset or worsening joint symptoms. Patients with Co-morbid Asthma: Advise patients with co-morbid asthma not to adjust or stop their asthma treatments without consultation with their physicians.Īrthralgia: 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.

Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. 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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