Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
Over 2,500 patients were exposed to galcanezumab in migraine prophylaxis studies supporting the initial registration of Galcanezumab. Over 1,400 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 in the migraine clinical trials 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 reactions.

Tabulated list of adverse reactions

Table 1. List of adverse reactions in clinical studies and post-marketing reports Frequency estimate: 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).




System organ class      Very common             Common              Uncommon               Rare 
Immune system                                                                          Anaphylaxis disorders                                                                              Angioedema Ear and labyrinth                          Vertigo disorders
Gastrointestinal                           Constipation disorders
Skin and                                   Pruritus              Urticaria subcutaneous                               Rash tissue disorders
General disorders        Injection site and administration       pain site conditions          Injection site reactionsa a
Most frequently reported terms (≥ 1%) were: Injection site reaction, Injection site erythema, Injection site pruritus, Injection site bruising, Injection site swelling.

Description of selected adverse reactions

Injection site pain or reactions
The majority of reactions 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 reaction 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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il