Aimovig

Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. Posology Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with erenumab. The recommended dose is 70 mg erenumab every 4 weeks.

1). 3 Each 140 mg dose is given either as one subcutaneous injection of 140 mg or as two subcutaneous injections of 70 mg. Clinical studies have demonstrated that the majority of patients responding to therapy showed clinical benefit within 3 months.

Consideration should be given to discontinuing treatment in patients who have shown no response after 3 months of treatment. Evaluation of the need to continue treatment is recommended regularly thereafter. Special populations Elderly (aged 65 years and over) Aimovig has not been studied in elderly patients.

No dose adjustment is required as the pharmacokinetics of erenumab are not affected by age. 2). Paediatric population The safety and efficacy of Aimovig in children below the age of 18 years have not yet been established. No data are available.

Method of administration Aimovig is for subcutaneous use. Aimovig is intended for patient self-administration after proper training. The injections can also be given by another individual who has been appropriately instructed. 2). Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard.

Pre-filled syringe The entire contents of the Aimovig pre-filled syringe should be injected. Each pre-filled syringe is for single use only and designed to deliver the entire contents with no residual content remaining. Comprehensive instructions for administration are given in the instructions for use in the package leaflet.

Pre-filled pen The entire contents of the Aimovig pre-filled pen should be injected. Each pre-filled pen is for single use only and designed to deliver the entire contents with no residual content remaining. Comprehensive instructions for administration are given in the instructions for use in the package leaflet.

Summary of the safety profile A total of over 2 500 patients (more than 2 600 patient years) have been treated with Aimovig in registration studies. Of these, more than 1 300 patients were exposed for at least 12 months and 218 patients were exposed for 5 years.

The overall safety profile of Aimovig remained consistent for 5 years of long-term open-label treatment. 8%). Most of the reactions were mild or moderate in severity. Less than 2% of patients in these studies discontinued due to adverse reactions.

Tabulated list of adverse reactions Table 1 lists all adverse drug reactions that occurred in Aimovig-treated patients during the 12-week placebo-controlled periods of the studies, as well as in the post-marketing setting. Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.

Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: 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); not known (cannot be estimated from the available data).

6 Table 1 List of adverse reactions System Organ Class Adverse reaction Frequency category Immune system disorders Hypersensitivity reactionsa including anaphylaxis, angioedema, rash, swelling/oedema and urticaria Common Gastrointestinal disorders Constipation Common Oral soresb Not known Skin and subcutaneous tissue disorders Pruritusc Common Alopecia Rashd Not known Musculoskeletal and connective tissue disorders Muscle spasms Common General disorders and administration site conditions Injection site reactionsa Common a See section “Description of selected adverse reactions” b Oral sores includes preferred terms of stomatitis, mouth ulceration, oral mucosal blistering.

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. Hypersensitivity reactions Serious hypersensitivity reactions, including rash, angioedema, and anaphylactic reactions, have been reported with erenumab in post-marketing experience.

These reactions may occur within minutes, although some may occur more than one week after treatment. In that context, patients should be warned about the symptoms associated with hypersensitivity reactions. 3). Constipation Constipation is a common adverse reaction of erenumab and is usually mild or moderate in intensity.

In a majority of the cases, the onset was reported after the first dose of erenumab; however patients have also experienced constipation later on in the treatment. In most cases constipation resolved within three months. In the post-marketing setting, constipation with serious complications has been reported with erenumab.

In some of these cases hospitalisation was required, including cases where surgery was necessary. History of constipation or the concurrent use of medicinal products associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

Patients should be warned about the risk of constipation and advised to seek medical attention in case constipation does not resolve or worsens. Patients should seek medical attention immediately if they develop severe constipation.

Constipation should be managed promptly as clinically appropriate. For severe constipation, discontinuation of treatment should be considered. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

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