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SAFETY INFORMATION
Indication & clinical use:
PrVyepti® (eptinezumab for injection) is indicated for the prevention of migraine in adults who have at least 4 migraine days per month. Vyepti® should be prescribed by healthcare professionals experienced in the diagnosis and treatment of migraine.
No data are available in the pediatric population (<18 years of age). Therefore, Vyepti® is not authorized for pediatric use.
The safety and efficacy of Vyepti® has not been established in geriatric patients (≥65 years of age). The clinical study program of Vyepti® did not include sufficient numbers of these patients to determine whether they respond differently from younger patients.
Most serious warnings and precautions:
Hypersensitivity reactions: Serious hypersensitivity reactions, including angioedema, urticaria, rash and anaphylactic reactions have been reported with the CGRP-class products including Vyepti®. These reactions may develop within minutes of the infusion. If a serious hypersensitivity reaction occurs, administration of Vyepti® should be discontinued immediately and appropriate therapy initiated.
Other relevant warnings and precautions:
• Patients with cardiovascular diseases
• Patients with diabetes or morbid obesity
• Patients with hereditary fructose intolerance (HFI)
• Hepatic insufficiency
• Patients with HIV, Hepatitis B and C
• Patients with autoimmune disorder
• Patients with neurological disorder
• Renal insufficiency
• Fertility
• Pregnancy
• Breastfeeding
For more information:
Please consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-800-586-2325.
Reference: Vyepti® Product Monograph. Lundbeck Canada Inc.