Ajovy Special Precautions

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.
Hypersensitivity: Hypersensitivity reactions such as rash, pruritus, urticaria and swelling have been reported uncommonly with fremanezumab (see Adverse Reactions). Most reactions were reported from within hours to one month after administration and were mild to moderate, but some led to discontinuation or required corticosteroid treatment. If a hypersensitivity reaction occurs, discontinuation of fremanezumab administration should be considered and appropriate therapy should be initiated.
Major cardiovascular diseases: Patients with certain major cardiovascular diseases were excluded from clinical studies (see Pharmacology: Pharmacodynamics under Actions). No safety data are available in these patients.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., is essentially "sodium-free".
Effects on ability to drive and use machines: AJOVY has no or negligible influence on the ability to drive and use machines.