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 13

HOS-138361 · Präparat HOS-098186

Approximately 8% of patients with COPD who received dupilumab 300 mg Q2W for 52 weeks developed antibodies to dupilumab; approximately 3% exhibited persistent ADA responses and approximately 3% had neutralizing antibodies. Approximately 4.7% of adult patients with CSU who received dupilumab 300 mg Q2W and adolescent patients with CSU who received dupilumab 300 mg or 200 mg Q2W for 24 weeks developed antibodies to dupilumab; approximately 0.5% exhibited persistent ADA responses and approximately 1% had neutralizing antibodies. No paediatric patients 2 to 11 years of age with CSU who received dupilumab 200 mg Q4W, 300 mg Q4W, or 200 mg Q2W for 24 weeks developed a positive ADA response to dupilumab.

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