Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

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 effect

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


AIM API Aug23 V8                               Page 2 of 14                      EU SmPC July23 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. If a serious or severe hypersensitivity reaction occurs, appropriate therapy should be initiated and treatment with erenumab should be discontinued (see section 4.3).

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.

Latex-sensitive individuals

The removable cap of of this medicinal product contains latex rubber, which may cause severe allergic reactions.

Sodium content

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

Effects on Driving

4.7   Effects on ability to drive and use machines

Aimovig is expected to have no or negligible influence on the ability to drive and use machines.