Tabulated Summary of Adverse Reactions: Adverse reactions are displayed by system organ class and frequency as follows using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), and very rare (< 1/10,000). (See Table 7).
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Immunogenicity: As with all therapeutic proteins, there is potential for immunogenicity. The immunogenicity of romosozumab has been evaluated using a screening immunoassay for the detection of binding anti-romosozumab antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro assay was performed to detect neutralising antibodies.
In postmenopausal women dosed with 210 mg monthly EVENITY, the incidence of anti-romosozumab antibodies was 18.1% (1072 of 5914) for binding antibodies and 0.8% (50 of 5914) for neutralising antibodies. Across all doses studied in postmenopausal women, the pooled incidence of binding antibodies and neutralising antibodies was similar to the 210 mg monthly dose, respectively. No impact to the efficacy and safety of romosozumab was observed in the presence of anti-romosozumab antibodies.
Reporting of Suspected Adverse Reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions as per local regulations.
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