Nebenwirkungen · Tegsedi
Tegsedi 284 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 9
HOS-141991 · Präparat HOS-098728
Immunogenicity In the pivotal Phase 2/3 study, 30.4% of patients treated with inotersen tested positive for anti-drug antibodies following 15 months of treatment. Development of anti-drug antibodies to inotersen was characterised by late onset (median onset > 200 days) and low titer (median peak titer of 284 in the pivotal study). No effect on the pharmacokinetic properties (maximum plasma concentration (Cmax), area under the curve (AUC) or half-life) and efficacy of inotersen was observed in the presence of anti-drug antibodies, but patients with anti-drug antibodies had more reactions at the injection site.
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Version 2026-06-04T16:00:00Z · SHA-256 e7a3d6958e7ed25c1232e5e4f0396780c8c247b46fe67d9aef17e4a907e8d778 · Passage 0d70e41cd1c2c14a9777813a5c5190160a8c050d2068adcd2731e60d45999574 · Zeichen 4170–4786 im Abschnitt