Patients with certain major cardiovascular diseases were excluded from clinical studies (see Pharmacology: Pharmacodynamics under Actions). No safety data are available in these patients.
Hypersensitivity reactions: Serious hypersensitivity reactions, including rash, angioedema, and anaphylactoid 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, initiate appropriate therapy and do not continue treatment with erenumab (see Contraindications).
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.
Latex-sensitive individuals: The removable cap of the Aimovig pre-filled syringe/pen contains dry natural rubber latex, which may cause allergic reactions in individuals sensitive to latex.
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.