DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/mL solution in a single-dose vial
The most common adverse reactions (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity
To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at
1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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INDICATION AND IMPORTANT SAFETY INFORMATION
VYEPTI (eptinezumab-jjmr) is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.
The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.