Summary of the Safety Profile: The adverse reactions described in the table as follows are based on 12-month pooled data from 3695 postmenopausal women with osteoporosis treated with EVENITY in Phase II and Phase III, placebo-controlled clinical trials [see Adverse Reactions]. The adverse reactions in EVENITY treated patients (N = 2040) in a double blind, Phase III active-controlled study were similar in type to those seen in the placebo-controlled trials. The most common adverse reactions (≥ 1/10) from the pooled safety data were viral upper respiratory tract infection and arthralgia.
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).
Click on icon to see table/diagram/image
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.