Emgality 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.
Cardiovascular risk: Patients with certain major cardiovascular diseases were excluded from clinical studies (see Pharmacology: Pharmacodynamics under Actions). No safety data are available in these patients.
Serious hypersensitivity: Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been reported (see Adverse Reactions). Serious hypersensitivity reactions may occur within 1 day after galcanezumab administration, however cases with a delayed onset (ranging from more than 1 day to 4 weeks after administration) have been reported. In some cases, hypersensitivity reactions had a prolonged duration. If a serious hypersensitivity reaction occurs, administration of galcanezumab should be discontinued immediately and appropriate therapy initiated (see Contraindications). Patients should be informed on the possibility of a delayed onset hypersensitivity reaction and instructed to contact their physician.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per 120 mg dose, i.e., is essentially "sodium-free".
Effects on ability to drive and use machines: Galcanezumab may have a minor influence on the ability to drive and use machines. Vertigo may occur following the administration of galcanezumab (see Adverse Reactions).