EMGALITY Solution for injection Ref.[7656] Active ingredients: Galcanezumab

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Cardiovascular risk

Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1). No safety data are available in these patients.

Serious hypersensitivity

Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been reported. If a serious hypersensitivity reaction occurs, administration of galcanezumab should be discontinued immediately and appropriate therapy initiated.

Excipients

This medicinal product contains less than 1 mmol sodium (23 mg) per 120 mg dose, i.e., is essentially “sodium-free”.

No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.

Pregnancy

There are limited data from the use of galcanezumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Human immunoglobulin (IgG) is known to cross the placental barrier. As a precautionary measure, it is preferable to avoid the use of galcanezumab during pregnancy.

Breast-feeding

It is unknown whether galcanezumab is excreted in human milk. Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. Afterwards, use of galcanezumab could be considered during breast-feeding only if clinically needed.

Fertility

The effect of galcanezumab on human fertility has not been evaluated. Fertility studies in animals do not indicate harmful effects with respect to male and female fertility (see section 5.3).

Galcanezumab may have a minor influence on the ability to drive and use machines. Vertigo may occur following the administration of galcanezumab (see section 4.8).

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 placebocontrolled 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 events.

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).

Immune system disorders

Rare: Anaphylaxis, Angioedema

Ear and Labyrinth System

Common: Vertigo

Gastrointestinal System

Common: Constipation

Skin and Subcutaneous Tissue

Common: Pruritus, Rash

Uncommon: Urticaria

General disorders and administration site conditions

Very common: Injection site pain, Injection site reactions^a

^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 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 listed in Appendix V

Not applicable.