Nebenwirkungen · Onpattro
Onpattro 2 mg/mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 7
HOS-140746 · Präparat HOS-098570
In clinical studies, all patients received premedication with a corticosteroid, paracetamol, and H1 and H2 blockers to reduce the risk of IRRs. In the double-blind placebo-controlled study, 18.9% of Onpattro-treated patients experienced IRRs, compared to 9.1% of placebo-treated patients. In Onpattro-treated patients, all IRRs were either mild (95.2%) or moderate (4.8%) in severity. Among Onpattro-treated patients who experienced an IRR, 78.6% experienced the first IRR within the first 2 infusions. The frequency of IRRs decreased over time. Some patients still experienced IRRs after 18 months of treatment, and in a few patients IRRs continued to be frequent. Few IRRs led to infusion interruption. IRRs resulted in permanent discontinuation of Onpattro in < 1% of patients in clinical studies. For clinical management of IRRs, see section 4.4.
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