Pontevia Adverse Reactions

Summary of the safety profile: Over 2500 patients were exposed to galcanezumab in clinical studies in migraine prophylaxis. Over 1400 patients were exposed to galcanezumab during the double-blind treatment phase of the placebo-controlled phase 3 studies. 279 patients were exposed for 12 months.
The reported adverse drug reactions for 120 mg and 240 mg were injection site pain (10.1%/11.6%), injection site reactions (9.9%/14.5%), vertigo (0.7%/1.2%), constipation (1.0%/1.5%), pruritus (0.7%/1.2%) and urticaria (0.3%/0.1%). Most of the reactions were mild or moderate in severity. Less than 2.5% of patients in these studies discontinued due to adverse events.
Tabulated list of adverse reactions: See Table 3.

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Description of selected adverse reactions: Injection site pain or reactions: The majority of events related to the injection site were mild to moderate and less than 0.5% of patients exposed to galcanezumab during the phase 3 studies discontinued the treatment due to an injection site reaction. The majority of injection site reactions were reported within 1 day and on average resolved within 5 days. In 86% of the patients reporting injection site pain, the event occurred within 1 hour of injection and resolved on average in 1 day. One percent of the patients exposed to galcanezumab during the phase 3 studies experienced severe pain at the injection site.
Urticaria: While urticaria is uncommon, serious cases of urticaria have been reported in galcanezumab clinical studies.
Immunogenicity: In the clinical studies, the incidence of anti-drug antibody development during the double-blind treatment phase was 4.8% in patients receiving galcanezumab once monthly (all but one of whom had in vitro neutralizing activity). With 12 months of treatment, up to 12.5% of galcanezumab-treated patients developed anti-drug antibodies, most of which were of low titre and tested positive for neutralising activity in vitro. However, the presence of anti-drug antibodies did not affect the pharmacokinetics, efficacy, or safety of galcanezumab.
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 via the national reporting system.