Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Dupixent

Dupixent 300 mg solution for injection in pre-filled syringe Dupixent 300 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 11

HOS-138342 · Präparat HOS-098186

Conjunctivitis and keratitis related events Conjunctivitis and keratitis occurred more frequently in atopic dermatitis patients who received dupilumab compared to placebo in atopic dermatitis studies. Most patients with conjunctivitis or keratitis recovered or were recovering during the treatment period. In the long-term OLE atopic dermatitis study (AD-1225) at 5 years, the respective rates of conjunctivitis and keratitis remained similar to those in the dupilumab arm in the placebo controlled atopic dermatitis studies. Among asthma and COPD patients, the frequency of conjunctivitis and keratitis was low and similar between dupilumab and placebo. Among CRSwNP and Prurigo Nodularis (PN) patients the frequency of conjunctivitis was higher in dupilumab than placebo, though lower than that observed in atopic dermatitis patients. Among patients with EoE and CSU, the frequency of conjunctivitis was low and similar between dupilumab and placebo groups. There were no cases of keratitis in the CRSwNP, PN, EoE, and CSU development program (see section 4.4).

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