Nebenwirkungen · Loargys
Loargys 5 mg/ml solution for injection/infusion · Abschnitt 4.8 · PDF-Seite 7
HOS-147743 · Präparat HOS-099734
There is potential for immunogenicity to pegylated therapeutic proteins. The observed incidence of anti-drug antibodies (ADAs) is highly dependent on the sensitivity and specificity of the assay. Across all clinical trials in the pegzilarginase ARG1-D development program, 12 of 48 subjects (25%) tested positive for ADAs against PEG and/or the protein moiety of pegzilarginase, with the majority detected early after the first dose. There was no assay available for detecting neutralising antibodies during the clinical development programme. The ADAs were transient in nature and resolved during continued treatment. The presence of ADAs was associated with transient changes in the pharmacokinetics (PK) and pharmacodynamics (PD) of Loargys in patients with ARG1-D.
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