Aquipta Adverse Reactions

Summary of the safety profile: Safety was evaluated in 2 657 patients with migraine who received at least one dose of atogepant in clinical studies. Of these, 1 225 patients were exposed to atogepant for at least 6 months and 826 patients were exposed for 12 months.
In 12-week, placebo-controlled clinical studies, 678 patients received at least one dose of atogepant 60 mg once daily, and 663 patients received placebo.
The most commonly reported adverse drug reactions were nausea (9%), constipation (8%), and fatigue/somnolence (5%). Most of the reactions were mild or moderate in severity. The adverse reaction that most commonly led to discontinuation was nausea (0.4%).
Tabulated list of adverse reactions: Adverse reactions reported in clinical trials and from post-marketing experience are listed as follows by system organ class and frequency, most frequent reactions first. Frequencies are defined as follows: 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), or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. (See Table 4.)

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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 according to local requirements.