DUPIXENT does not have a boxed warning. In the DUPIXENT pivotal PN clinical trials, the most common adverse reactions in adult patients with prurigo nodularis (≥2%, pooled safety data across PRIME and PRIME2) were nasopharyngitis (5% for DUPIXENT vs 2% for placebo); conjunctivitis (4% for DUPIXENT vs 1% for placebo); herpes infection (3% for DUPIXENT vs 0% for placebo); dizziness (3% for DUPIXENT vs 1% for placebo); myalgia (3% for DUPIXENT vs 1% for placebo); and diarrhea (3% for DUPIXENT vs 1% for placebo). No patients treated with DUPIXENT (0%) discontinued treatment due to adverse events vs 3% with placebo. Patients should discontinue DUPIXENT if a clinically significant hypersensitivity reaction occurs or until a parasitic (helminth) infection resolves in a patient who does not respond to anti-helminth treatment.1
Note: Select Important Safety Information: Warnings and Precautions—Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, angioedema, generalized urticaria, rash, erythema nodosum, and erythema multiforme have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue DUPIXENT. Please see additional Warnings and Precautions in the Prescribing Information and Important Safety Information below.