Summary of the safety profile: A total of over 2,500 patients (more than 2,600 patient years) have been treated with Aimovig in registration studies. Of these, more than 1,300 patients were exposed for at least 12 months.
The reported adverse drug reactions for 70 mg and 140 mg were injection site reactions (5.6%/4.5%), constipation (1.3%/3.2%), muscle spasms (0.7%/2.0%) and pruritus (1.0%/1.8%). Most of the reactions were mild or moderate in severity. Less than 2% of patients in these studies discontinued due to adverse events.
Tabulated list of adverse reactions: Table 3 lists all adverse drug reactions that occurred in Aimovig-treated patients during the 12-week placebo-controlled periods of the studies. Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). (See Table 3.)
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Description of selected adverse reactions: Injection site reactions: In the integrated 12-week placebo-controlled phase of the studies, injection site reactions were mild and mostly transient. There were no cases of discontinuation due to injection site reactions. The most frequent injection site reactions were localised pain, erythema and pruritus. Injection site pain typically subsided within 1 hour after administration.
Cutaneous reactions: Non-serious cases of rash, pruritus and swelling/oedema were observed, which in the majority of cases were mild and did not lead to treatment discontinuation.
Immunogenicity: In the clinical studies, the incidence of anti-erenumab antibody development during the double-blind treatment phase was 6.3% (56/884) among subjects receiving a 70 mg dose of erenumab (3 of whom had in vitro neutralising activity) and 2.6% (13/504) among subjects receiving a 140 mg dose of erenumab (none of whom had in vitro neutralising activity). There was no impact of anti-erenumab antibody development on efficacy or safety.
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.