Aimovig Special Precautions

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 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, initiate appropriate therapy and do not continue treatment with erenumab (see Contraindications).
Constipation: Constipation is a common undesirable effect of Aimovig and is usually mild or moderate in intensity. In a majority of the cases, the onset was reported after the first dose of Aimovig; 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.
Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of Aimovig in the post-marketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalisation. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. Aimovig was discontinued in many of the reported cases.
Monitor patients treated with Aimovig for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of Aimovig is warranted if evaluation fails to establish an alternative etiology.
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 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.