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Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. Posology The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.

Patients should be instructed to inject a missed dose as soon as possible and then resume monthly dosing. The treatment benefit should be assessed within 3 months after initiation of treatment. Any further decision to continue treatment should be taken on an individual patient basis.

Evaluation of the need to continue treatment is recommended regularly thereafter. Elderly (≥ 65 years) There is limited information in subjects aged ≥ 65 years. No dose adjustment is required as the pharmacokinetics of galcanezumab are not affected by age.

2). Paediatric population The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established. No data are available. 3 There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of migraine.

Method of administration Subcutaneous use. A patient may self-inject galcanezumab by following the Instructions for Use. Galcanezumab is to be injected subcutaneously in the abdomen, thigh, back of the upper arm, or in the gluteal region.

After training, patients may self-inject galcanezumab if a healthcare professional determines that it is appropriate. Comprehensive instructions for administration are given in the Package Leaflet.

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. 1 %). Most of the reactions were mild or moderate in severity. 5 % of patients in these studies discontinued due to adverse reactions. 5 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 disorders Anaphylaxis Angioedema Ear and labyrinth disorders Vertigo Gastrointestinal disorders Constipation Skin and subcutaneous tissue disorders Pruritus Rash Urticaria General disorders and administration site conditions Injection site pain 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.

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. 8 % in patients receiving galcanezumab once monthly (all but one of whom had in vitro neutralizing activity). 5 % of galcanezumab-treated patients developed anti-drug antibodies, most of which were of low titre and tested positive for neutralising activity in vitro.

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. 1). No safety data are available in these patients. 8). Serious hypersensitivity reactions may occur within 1 day after galcanezumab administration, however cases with a delayed onset (ranging from more than 1 day to 4 weeks after administration) have been reported.

In some cases, hypersensitivity reactions had a prolonged duration. 3). Patients should be informed on the possibility of a delayed onset hypersensitivity reaction and instructed to contact their physician. Excipients This medicine contains less than 1 mmol sodium (23 mg) per 120 mg dose, that is to say essentially “sodium-free”.

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